This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes (NCT00306787), a randomized phase 3 study. The primary outcome is Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00306787 |
| Phase | Phase 3 |
| Condition | Genital Herpes |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 1179 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Novartis Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
Immunocompetent adults with recurrent genital herpes. The primary endpoint used the modified Intent To Treat population: participants who initiated study treatment for a recurrence and developed non-aborted genital herpes lesions during that treated recurrence. Further wording about exclusions in the registry record is incomplete.
Intervention
Patient-initiated famciclovir 1000 mg twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions, with the second dose approximately 12 hours later. Matching placebo was used to support blinding.
Comparator
Patient-initiated valacyclovir 500 mg twice a day for 3 consecutive days, with the first dose within 6 hours after onset of prodromal symptoms or genital herpes lesions. Matching placebo was used to support blinding.
Primary question
How did investigator-assessed time to healing of all non-aborted genital herpes lesions compare between the famciclovir and valacyclovir groups? The endpoint was assessed from the first study dose through Day 20, with a stated timeframe beginning 72 hours after treatment initiation.
The trial addresses a comparison between two treatment schedules in adults with recurrent genital herpes, rather than a comparison with no treatment. The registry record describes the aim as assessing safety and efficacy, including lesion duration and associated symptoms. The posted primary result concerns healing time for non-aborted lesions; it does not by itself report every aspect of that broader aim.
Both schedules were patient-initiated, so treatment began in relation to the onset of prodromal symptoms or lesions. The record specifies the intended timing of the first dose and the dosing schedule for each active treatment. It does not report how closely participants followed those instructions or how treatment timing varied in practice.
The question is about a time-to-event outcome. A shorter observed time to healing would correspond to earlier healing, but the primary comparison should be interpreted through its reported estimates and uncertainty, not from treatment labels or dosing duration alone. The registry record does not report a threshold for a clinically important difference in healing time.
3. Trial Design
This was a Phase 3, randomized, double-blind, parallel-group study. The official title describes it as multicenter. A total enrollment of 1179 is recorded. The study status is completed, with a recorded start of 2006-03 and primary completion in 2008-02. The sponsor was Novartis Pharmaceuticals.
Participants were assigned to famciclovir or valacyclovir. The famciclovir schedule was 1000 mg twice a day for one day; the valacyclovir schedule was 500 mg twice a day for 3 consecutive days. Each schedule began with a dose intended within 6 hours after onset of prodromal symptoms or genital herpes lesions. Matching placebo for the other drug was included in the intervention descriptions, consistent with the double-blind design. The record does not describe the practical procedures used to maintain masking or whether masking was assessed.
The primary endpoint was investigator-assessed time to healing of all non-aborted genital herpes lesions. The primary analysis population was the modified Intent To Treat population, described as participants who initiated treatment with the intention of treating a recurrence and developed non-aborted lesions during that recurrence. The record's population wording includes an incomplete exclusion phrase, so the full eligibility detail cannot be reconstructed from the posted description.
The registry lists six outcome measures, including the primary endpoint and five secondary outcomes. Those secondary outcomes address aborted lesions, healing of all lesions, symptom resolution, and second recurrence. The registry record does not report numerical results for those secondary outcomes in the information summarized for this analysis. The number of posted analyses is 1.
The record does not report the planned sample-size justification, a prespecified non-inferiority margin, interim analyses, or a full statistical analysis plan. The sample-size illustrations associated with the results are planning illustrations based on the observed effect, not the trial's design calculations and not observed power. They should not be read as evidence about the original design or as a measure of the probability that the study detected an effect.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: A total of 1179 patients were randomized in the study and followed to their first genital herpes recurrence. A total of 423 patients did not experience a recurrence within 4 months of randomization therefore, no treatment was initiated and study drug was not taken. A total of 756 patients were randomized and took study drug (safety population).
Overall Study
| Stage | Famciclovir | Valacyclovir |
|---|---|---|
| STARTED | 579 | 600 |
| Received Study Drug (Safety Population) | 371 | 385 |
| Intent to Treat (ITT) Population | 370 | 381 |
| COMPLETED | 345 | 359 |
| NOT COMPLETED | 234 | 241 |
Reasons for not completing this period:
| Reason | Famciclovir | Valacyclovir |
|---|---|---|
| Discontinued without taking study drug | 208 | 215 |
| Adverse Event | 1 | 1 |
| Lack of Efficacy | 1 | 0 |
| Protocol Violation | 8 | 10 |
| Withdrawal by Subject | 2 | 9 |
| Lost to Follow-up | 9 | 6 |
| Administrative problems | 4 | 0 |
| Abnormal laboratory value(s) | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Modified Intent To Treat (mITT) population. The mITT population included all patients who initiated treatment with the study drug, with the intention of treating genital herpes recurrences who developed non-aborted genital herpes lesions during the treated recurrence except those with confirmed aborted lesions at the final clinical assessment.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Famciclovir | Valacyclovir | Total |
|---|---|---|---|---|
| Participants analysed | 370 | 381 | 751 | |
| Age Continuous | years | 39.6 (SD 11.6) | 41.7 (SD 12.6) | 40.7 (SD 12.2) |
| Sex: Female, Male: Female | Participants | 245 | 243 | 488 |
| Sex: Female, Male: Male | Participants | 125 | 138 | 263 |
6. Primary Endpoint
The registry lists the primary outcome as Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions, measured over 72 hours after initiation of study medication up to Day 20.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | days |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint was investigator-assessed time to healing of all non-aborted genital herpes lesions. The registry defines the starting point as the first study dose taken no earlier than the recurrence of genital herpes, and the endpoint as the investigator-assessed time of healing. Healing was defined as loss of all crusts and re-epithelialization of the lesions; erythema could still be present.
Non-aborted lesions were defined as lesions that underwent vesicle, ulcer or soft-crust, and/or hard-crust formation and required re-epithelialization for healing. This distinction means that lesions that did not progress to the specified lesion stages were not part of the primary endpoint's lesion-healing definition. The primary endpoint therefore addresses time to healing within a defined subset of lesions, not the duration of every recurrence or every symptom.
A time-to-event endpoint retains information about when healing occurred, rather than recording only whether healing was observed at a fixed assessment. In general, the median time describes the point by which half of the relevant event-time distribution has experienced the event, subject to the analysis method and available follow-up. The registry states that the median was estimated using Kaplan-Meier methods and that missing observations were censored at the last clinical lesion observation.
The stated timeframe was 72 hours after initiation of study medication up to Day 20. The registry record does not explain further how that timeframe relates to any assessments before its stated start. The endpoint is useful for comparing the timing of lesion healing, but it does not directly measure symptom burden, recurrence frequency over longer follow-up, or all safety outcomes.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted median healing time was 4.25 days in the famciclovir group and 4.08 days in the valacyclovir group. The associated displayed lower and upper bounds were 3.06 and 5.78 days for famciclovir, and 3.02 and 5.8 days for valacyclovir. The registry labels the primary measure as a median and lists inter-quartile range as its dispersion measure; the posted arm-level bounds are stated without assigning them a different interpretation.
The sponsor-reported comparison used the Hodges-Lehmann method and gave a median difference of 0.16 days, with a 95% confidence interval from -0.15 to 0.60. The registry classifies this comparison as a non-inferiority or equivalence analysis. No p-value is reported for this comparison, and the registry record does not report the margin that would be needed to interpret a non-inferiority conclusion against a prespecified criterion.
In general, a confidence interval expresses the uncertainty around an estimated comparison under the assumptions of the analysis. This interval includes zero, so the posted estimate is compatible with no difference in median healing time as well as with differences in either direction under the reported scale. Its upper and lower limits also show that the data do not pin down the comparison to a single value. The interval alone does not establish equivalence or non-inferiority: those conclusions require a stated margin and a comparison of the interval with that margin.
The arm medians are close as posted, but proximity of point estimates is not a substitute for an uncertainty assessment. Conversely, uncertainty does not mean that the treatments are necessarily different. The posted comparison is the relevant estimate for the treatment contrast, and its interval communicates the range of values reasonably compatible with that analysis. No treatment-effect threshold for clinical importance is reported, so the size of the estimated difference cannot be judged against a registry-stated clinical threshold.
The result is specific to the modified Intent To Treat population, the definition of non-aborted lesions, and the follow-up window stated for this endpoint. It should not be extended to the secondary outcomes, for which numerical results are not reported in the analysis information. The trial enrolled 1179 participants overall, while the reported primary endpoint groups included 249 participants for famciclovir and 253 for valacyclovir. These are not the same denominators, reflecting that the primary endpoint analysis population was defined more narrowly than total enrollment.
There is no posted p-value for the primary comparison. It is therefore more informative to describe the point estimate and interval than to characterize the result as statistically significant or not significant. The record also does not report the non-inferiority margin, any multiplicity adjustment, or enough detail to determine how the analysis was positioned among all planned analyses. The result is a reported comparative estimate with uncertainty, not an unqualified statement about treatment effectiveness.
9. Statistical Methods Explained
The primary outcome is a time-to-event measure, where the event is investigator-assessed healing of non-aborted lesions. Time-to-event methods are useful when participants can have different observed follow-up times or when the event is not observed for everyone during follow-up. They use the timing of events and account for participants whose event time is not observed in the same way as a completed event.
The registry says the median was estimated with the Kaplan-Meier method. In general, the Kaplan-Meier estimate describes the event-free proportion over time while accounting for censored observations. The median event time is identified from that estimated curve at the point where the estimated event-free proportion reaches one half. This is distinct from taking an ordinary average of observed times, which can be misleading if some event times are censored.
The registry specifies that missing values were censored at the time of the last clinical lesion observation. In general, censoring indicates that the exact event time is not observed, while information up to the last observation remains available. The method relies on assumptions about the censoring process; if the chance of being censored is related to the unobserved event time in a way not adequately addressed, estimates may be affected. The registry record does not report an assessment of those assumptions or a sensitivity analysis for missing observations.
The primary endpoint description also defines the event carefully. Healing required loss of all crusts and re-epithelialization, while erythema could remain. Only lesions that progressed through specified stages and required re-epithelialization were classified as non-aborted. Outcome definitions matter because a change in how healing or eligible lesions are classified can change which observations contribute to the analysis. The record does not report additional adjudication procedures beyond investigator assessment.
The sponsor-reported contrast was calculated with the Hodges-Lehmann method and is described as a median difference using final values. In general, the Hodges-Lehmann estimate is a robust way to summarize a location difference between two groups, based on pairwise differences between observations. It is not simply the subtraction of the two separately reported group medians. Its interpretation depends on the comparison's definition and analysis population. The registry lists the groups in the order famciclovir and valacyclovir, and reports the estimate as 0.16 days.
The 95% confidence interval for that contrast ranges from -0.15 to 0.60. In general, a confidence interval presents uncertainty around an estimate and helps distinguish a precise estimate from one that admits a broader range of plausible values. It is not the probability that the true effect lies within this particular interval. Nor does an interval crossing zero prove that the groups are identical. It indicates that the reported data and method do not exclude a zero contrast at the corresponding confidence level.
The registry classifies the comparison as non-inferiority or equivalence, but the margin is not reported. In general, a non-inferiority analysis asks whether a treatment is not worse than a comparator by more than a prespecified acceptable amount. Equivalence asks whether the difference lies within prespecified bounds in both directions. The bounds must be defined before the result is interpreted; without them, the label alone is not enough to determine whether the statistical criterion was met. The registry record does not report a p-value for the comparison.
The primary measure is a median-time analysis, and the posted comparison uses a method for a median difference. No recalculated two-arm result is reported for this endpoint. In general, recalculations from summary statistics can be useful checks, but they do not replace an analysis that uses the trial's participant-level data, prespecified methods, or censoring information. Here, the reported sponsor comparison is the available inferential comparison, while the arm-level medians offer a descriptive view of each group.
Other statistical quantities should be kept distinct from the primary comparison. The record lists six outcomes and five secondary outcomes, but numerical secondary results are not reported in the information considered for this discussion. The number of posted analyses is 1. These registry entries do not establish whether other analyses were planned or conducted, whether any adjustment for multiple testing was used, or how results were selected for reporting. Those details are not reported in the registry record.
Planning illustrations based on an observed effect answer a different question from the trial's observed analysis. In general, such calculations can show what sample size might be needed under stated assumptions and a chosen effect to detect. They are not observed power and do not reconstruct the original design rationale. The record's illustration assumptions include two-sided significance level 0.05, equal allocation, and a normal approximation; these are calculation assumptions and should not be mistaken for documented design choices for this trial. The original sample-size justification is not reported in the registry record.
Over-dispersion is a general concern when count outcomes vary more than a model's assumed distribution allows; in that situation, standard errors can be too small if the extra variability is ignored. It is not a feature of this primary median-time endpoint as described, and the registry record does not report a count model for the primary analysis. Such general considerations should not be used to infer an analysis that the record does not describe.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Hodges-Lehman | Median Difference (Final Values) 0.16 | -0.15 to 0.60 | not reported |
The sponsor-reported comparison is the central inferential result available for the primary endpoint: a Hodges-Lehmann median difference of 0.16 days with a 95% confidence interval from -0.15 to 0.60. It accompanies the arm-specific median estimates of 4.25 days for famciclovir and 4.08 days for valacyclovir. The group medians are descriptive summaries; the reported Hodges-Lehmann contrast is not necessarily obtained by subtracting those two medians.
No recalculated two-arm comparison is reported for this median-time endpoint. The available information therefore does not support presenting an independent recalculation as a second estimate. The sponsor's comparison should be read as the posted analysis, with its method and uncertainty, rather than as a result independently confirmed from summary statistics.
The comparison is labeled as a non-inferiority or equivalence analysis, but no margin is reported. That omission limits interpretation of the label: the estimate and interval can be described, but the registry record does not give the criterion needed to assess a non-inferiority or equivalence claim. No p-value is reported for the comparison either. The interval includes zero, but that alone does not demonstrate equivalence, establish non-inferiority, or show that a clinically important difference has been excluded.
The record does not identify a discrepancy between the sponsor analysis and an available recalculation. It also does not report enough detail to reproduce the participant-level analysis, including a full statistical analysis plan. The most defensible reading is therefore to state the sponsor's estimate and interval directly, while keeping the missing margin and analysis details in view.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists six outcome measures: the primary time to healing of non-aborted lesions and five secondary outcomes. The secondary outcomes concern aborted lesions, healing of all lesions, symptom resolution, and second recurrence. Numerical results for those secondary outcomes are not reported in the analysis information. The registry records one posted analysis, but that does not establish how many outcomes or analysis choices were prespecified or examined.
When a study evaluates multiple outcomes or multiple comparisons, the chance of at least one apparently unusual result can increase. In general, multiplicity procedures can control that risk, but the appropriate approach depends on the planned outcome hierarchy and analysis strategy. The registry record does not report a multiplicity adjustment, an outcome hierarchy, or a complete statistical analysis plan. It is therefore not possible to determine from the record whether the primary result was protected from other testing or how secondary findings should be interpreted together.
The primary analysis used the modified Intent To Treat population. The record describes this population as participants who initiated study treatment to treat genital herpes recurrences and developed non-aborted lesions during the treated recurrence. The available wording ends with an incomplete exclusion phrase, so the full population definition is not reported in the registry record. The primary endpoint group sizes were 249 for famciclovir and 253 for valacyclovir; overall enrollment was 1179. These populations and denominators should not be treated as interchangeable.
For the primary time-to-healing endpoint, missing observations were censored at the last clinical lesion observation. In general, this approach retains follow-up information before censoring, but conclusions can depend on why observations are missing and whether censoring is informative. The registry record does not report the amount or pattern of missing endpoint data, reasons for missingness, or sensitivity analyses. It also does not report a missing-data strategy for the secondary outcomes in the information.
The registry record does not report interim analyses, stopping rules, or the trial's sample-size justification. The sample-size illustrations are planning calculations based on an observed effect and are not evidence of the original design or observed power. These missing details limit reconstruction of the full analysis plan, but they do not change the estimates and interval that are posted for the primary comparison.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Famciclovir | 2 | 371 | 0.5% |
| Valacyclovir | 1 | 385 | 0.3% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Famciclovir | 66 of 371 |
| Valacyclovir | 47 of 385 |
Most frequent serious adverse event terms
| Event term | Organ system | Famciclovir | Valacyclovir |
|---|---|---|---|
| Myocardial ischemia | Cardiac disorders | 1 of 371 | 0 of 385 |
| Suicide Attempt | Psychiatric disorders | 1 of 371 | 0 of 385 |
| Substance Abuse | Psychiatric disorders | 0 of 371 | 1 of 385 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Famciclovir | Valacyclovir |
|---|---|---|---|
| Headache | Nervous system disorders | 29 of 371 | 17 of 385 |
| Nausea | Gastrointestinal disorders | 23 of 371 | 18 of 385 |
| Diarrhea | Gastrointestinal disorders | 8 of 371 | 5 of 385 |
| Vomiting | Gastrointestinal disorders | 5 of 371 | 3 of 385 |
| Abdominal pain | Gastrointestinal disorders | 1 of 371 | 4 of 385 |
Serious events with the highest arm-level rate: myocardial ischemia (0.3%), suicide attempt (0.3%), substance abuse (0.3%).
The posted serious adverse event counts were 2 affected participants among 371 at risk in the famciclovir group and 1 among 385 at risk in the valacyclovir group. For other adverse events, the posted counts were 66 among 371 at risk and 47 among 385 at risk, respectively. These are counts with the listed at-risk denominators, not the primary endpoint analysis group sizes.
The registry also lists myocardial ischemia, suicide attempt, and substance abuse among the top serious terms, each reported as 0.3%. The information available does not specify the treatment group or denominator for each term, so those percentages should not be attributed to either group. Death counts are not reported in the registry record.
These figures describe recorded events in the registry; they do not by themselves establish that an event was caused by a study treatment. The counts also do not provide a complete account of timing, severity, duration, or individual clinical context. The differing at-risk denominators matter when comparing counts, and no new percentages or comparative safety estimates should be inferred from the counts alone.
The registry's summary does not state how adverse events were collected or classified, whether all events were considered treatment-emergent, or whether exposure duration was incorporated into the comparison. The event figures should therefore be read as descriptive safety information, alongside the explicit limitations in reporting, rather than as a stand-alone causal comparison.
13. What the Result Does, and Does Not, Mean
The primary endpoint results describe investigator-assessed time to healing of non-aborted genital herpes lesions in the modified Intent To Treat population. The posted median estimates were 4.25 days for famciclovir and 4.08 days for valacyclovir. The sponsor-reported median difference was 0.16 days, with a 95% confidence interval from -0.15 to 0.60. Together, these statistics describe the observed contrast and the uncertainty around it; they do not establish that the schedules are identical.
The result does not, on its own, establish non-inferiority or equivalence. Although the registry labels the comparison as non-inferiority or equivalence, the margin is not reported. Without that prespecified boundary, the estimate and interval cannot be judged against the criterion for either conclusion. The record also does not report a p-value for this comparison.
The endpoint is narrower than the study's overall aims. It addresses healing of qualifying non-aborted lesions, not every lesion or all symptoms. The registry lists outcomes for aborted lesions, healing of all lesions, symptom resolution, and subsequent recurrence, but numerical results for those secondary outcomes are not reported in the analysis information. The primary endpoint should not be treated as a result for those separate outcomes.
The findings are also tied to the recorded study population, treatment schedules, endpoint definition, and observation window. They do not automatically generalize to people outside the described population or to other dosing schedules. The registry record does not report a threshold for a clinically important difference, so it is not possible to classify the reported difference as clinically meaningful or unimportant based on a stated trial criterion.
Safety counts are descriptive and do not establish causation. The serious and other adverse event figures have their own at-risk denominators, which differ from the primary endpoint group sizes. Details needed to assess event timing and attribution are not reported in the registry record. The primary efficacy estimate and the safety counts therefore answer different questions and should be considered separately.
Overall, the posted results support a precise description of the recorded endpoint estimates and their uncertainty. They do not supply every detail needed to evaluate the trial's full statistical plan, a non-inferiority margin, missing-data assumptions, multiplicity handling, or clinical importance. Those limits should accompany any interpretation of the primary comparison.
14. Why This Trial Matters Statistically
This trial illustrates why the treatment contrast and the group medians should be read as related but distinct summaries. The arm-level medians describe the estimated event time in each group, while the sponsor-reported Hodges-Lehmann statistic is the stated comparison between groups. The contrast has its own confidence interval, which communicates uncertainty beyond the point estimate.
It also shows the importance of endpoint definitions in time-to-event work. The outcome is not simply any change in a lesion: healing was defined by loss of all crusts and re-epithelialization, and the primary endpoint excluded lesions that did not meet the non-aborted definition. A reader needs those rules to understand what the median time represents and which participants contribute to the primary analysis.
The use of Kaplan-Meier estimation and censoring at the last clinical lesion observation makes missing follow-up relevant to interpretation. In general, censored observations contribute information up to their last observed time, but the method cannot remove uncertainty about unobserved event times. The record does not describe missingness patterns or sensitivity analyses, making those reporting gaps important for assessing robustness.
The registry's non-inferiority or equivalence label also makes the absent margin especially consequential. A point estimate close to zero and an interval that includes zero do not independently demonstrate equivalence. Interpretation requires a stated criterion. This distinction is broadly important in clinical research: failure to show a difference is not the same as demonstrating that a difference is acceptably small.
Finally, overall enrollment and primary analysis denominators answer different questions. The primary analysis was restricted to the modified Intent To Treat population with non-aborted lesions, so its group sizes are smaller than total enrollment. Recognizing that distinction prevents the entire enrollment from being mistaken for the number contributing to the primary endpoint.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record does not report the non-inferiority or equivalence margin, so the sponsor's classification cannot be fully evaluated against a stated decision boundary. The primary comparison also has no reported p-value. Its point estimate and confidence interval can be described, but the record does not establish whether a prespecified non-inferiority or equivalence criterion was met.
The primary analysis population definition is incomplete in the available registry wording. The record identifies participants who initiated treatment and developed non-aborted lesions during the treated recurrence, but the exclusion phrase at the end is truncated. This limits a complete account of who was included. Overall enrollment of 1179 should not be confused with the primary endpoint group sizes of 249 and 253.
The primary endpoint depends on investigator assessment and on a specific definition of healing. The record does not describe further adjudication procedures or report an assessment of consistency between assessors. It also states that missing values were censored at the last clinical lesion observation, but does not report missingness patterns, reasons for loss of observation, or sensitivity analyses.
Numerical results for the five secondary outcomes are not reported in the analysis information. The record lists six outcomes and one posted analysis, but does not report multiplicity handling, an outcome hierarchy, or a complete statistical analysis plan. It also does not report interim analyses or the original sample-size justification. Those omissions restrict reconstruction of the full prespecified analysis strategy.
The safety summary gives affected counts and at-risk denominators but does not report deaths, and the serious event terms are not linked to treatment groups in the available information. Details about event timing, duration, attribution, and collection procedures are not reported in the registry record. These limitations mean the figures should be treated as descriptive, not as a complete comparative safety analysis.
Finally, the registry does not state a threshold for a clinically important healing-time difference. Statistical uncertainty and clinical importance are separate considerations, and the available record does not provide the criterion needed to judge the latter. These limitations do not erase the posted estimates, but they narrow the conclusions that can be drawn from them.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes — NCT00306787.
- Registry record last updated 2011-06-30; status last verified 2011-06.
- Results first posted 2011-06-17.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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19. Record Summary
NCT00306787 records a completed Phase 3, randomized, double-blind, parallel-group study sponsored by Novartis Pharmaceuticals. It enrolled 1179 participants and compared patient-initiated famciclovir 1000 mg twice a day for one day with valacyclovir 500 mg twice a day for 3 consecutive days in immunocompetent adults with recurrent genital herpes.
The primary outcome was investigator-assessed time to healing of non-aborted genital herpes lesions. The posted median estimates were 4.25 days for famciclovir and 4.08 days for valacyclovir. The sponsor-reported Hodges-Lehmann median difference was 0.16 days, with a 95% confidence interval from -0.15 to 0.60.
The registry labels the comparison as non-inferiority or equivalence, but does not report the margin. Numerical results for the listed secondary outcomes are not reported in the analysis information. Missing-data details beyond censoring at the last clinical lesion observation, multiplicity handling, and the original sample-size justification are not reported in the registry record.