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 Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea (NCT00250458), a randomized phase 3 study. The primary outcome is Participants With Elimination of Nausea at 2 Hours Postdose.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00250458 |
| Phase | Phase 3 |
| Condition | Migraine |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 346 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Organon and Co |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people with migraine. The primary outcome population was the Full Analysis Set: randomized and treated participants with at least one post-baseline assessment within 2 hours after treatment. The registry enrollment is 346, but the record does not report the primary-outcome denominators by arm.
Intervention
Participants in the active-treatment arm received rizatriptan 10 mg as an orally disintegrating tablet, also described as an oral lyophilisate. The study title identifies the product as rizatriptan ODT.
Comparator
The comparison group received matching placebo. The study was randomized, double-blind and placebo-controlled, with a parallel-group model. The record does not describe the allocation ratio or how the randomization sequence was generated.
Primary question
The primary question was whether participants reported no nausea at 2 hours after treatment. Participants recorded nausea presence or absence in an electronic diary. The registry record does not report the number who met this endpoint in either arm, an effect estimate, or a statistical test of the between-arm comparison.
3. Trial Design
This was a Phase 3 randomized, double-blind, placebo-controlled, parallel-group study of rizatriptan ODT for migraine-associated nausea. The registry lists Organon and Co as the sponsor and gives an enrollment of 346. The recorded start is 2006-03, primary completion is 2006-10, and study status is completed.
The intervention arms are described as rizatriptan 10 mg orally disintegrating tablet/oral lyophilisate and matching placebo. Double masking indicates that the study was designed to keep treatment assignment concealed from participants and relevant study personnel, but the registry does not specify exactly who was masked or how the masking was maintained. The allocation is identified as randomized; sequence generation and concealment procedures are not reported in the registry record.
The primary endpoint was participants with elimination of nausea at 2 hours after treatment. A secondary outcome listed in the record was participants with pain relief at 2 hours postdose. Although the record identifies two outcome measures, it does not include the numerical results for the primary nausea endpoint or a statistical analysis of it. It also records no analyses. The enrollment figure should not be treated as the number contributing to the primary endpoint: that endpoint used a defined Full Analysis Set, and arm-specific analysis denominators are not reported in the registry record.
The record does not describe the planned allocation ratio, sample-size justification, interim monitoring, or the statistical analysis plan. Those design details cannot be inferred from the randomized, double-blind, parallel-group labels.
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: Each patient was to treat one migraine attack of moderate or severe intensity with accompanying nausea. Rescue medication was allowed for headache non-response or recurrence after 2 hours postdose. Patients were to treat a qualifying migraine attack within 3 months after randomization.
Overall Study
| Stage | Rizatriptan 10 mg | Placebo |
|---|---|---|
| STARTED | 232 | 114 |
| COMPLETED | 200 | 97 |
| NOT COMPLETED | 32 | 17 |
Reasons for not completing this period:
| Reason | Rizatriptan 10 mg | Placebo |
|---|---|---|
| Lost to Follow-up | 4 | 2 |
| Protocol Violation | 0 | 1 |
| Withdrawal by Subject | 4 | 2 |
| Lack of Migraine Attack | 20 | 9 |
| Qualifying migraine but did not treat | 3 | 3 |
| Other | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Full Analysis Set (FAS): The FAS population included all randomized and treated Participants who had at least one assessment within 2 hours post-dose (i.e., after baseline 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 | Rizatriptan 10 mg | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 232 | 114 | 346 | |
| Age, Continuous | Years | 40 (18 to 65) | 41 (18 to 60) | 40 (18 to 65) |
| Sex: Female, Male: Female | Participants | 207 | 103 | 310 |
| Sex: Female, Male: Male | Participants | 25 | 11 | 36 |
6. Primary Endpoint
The registry lists the primary outcome as Participants With Elimination of Nausea at 2 Hours Postdose, measured over At 2 hours after treatment.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counted participants who reported an absence of nausea at 2 hours after treatment. Nausea presence or absence was recorded by participants in an electronic diary; absence at that assessment was the endpoint definition. This makes the outcome binary for each participant: the participant either met the stated definition at the specified assessment or did not.
A fixed-time symptom measure can make a treatment comparison clinically interpretable by focusing on whether participants reached a defined state at a particular point after treatment. It does not, by itself, describe the full course of nausea between assessments, how quickly symptoms changed, or symptom severity. The registry description is about absence of nausea at the specified assessment, not a broader measure of sustained symptom relief.
The endpoint population was the Full Analysis Set, defined as randomized and treated participants with at least one assessment within 2 hours after treatment, following baseline assessment. The registry record does not report how many participants in each arm met this population definition or how many reported no nausea. Without those counts and an analysis, the size and precision of the treatment comparison cannot be assessed from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the trial question and endpoint definition, but it does not provide the numerical primary-outcome results. It gives no arm-specific counts of participants with elimination of nausea at 2 hours, no effect estimate, no confidence interval, and no p-value. The record also lists no analyses. Consequently, the posted information does not establish the direction, magnitude, or statistical precision of the primary comparison.
The enrollment figure of 346 is a trial-level registry figure, not an endpoint result or a guarantee that every enrolled participant contributed to the primary analysis. The Full Analysis Set required randomization, treatment, and at least one assessment within 2 hours after treatment following baseline. The number meeting that definition in each arm is not reported in the registry record. It would therefore be inappropriate to infer analysis denominators from enrollment or from the safety figures.
In general, an effect estimate describes the size and direction of a comparison, while a confidence interval indicates the range of values reasonably compatible with the data under the analysis assumptions. A p-value addresses how compatible the observed data are with a specified null model; it does not measure the size or clinical importance of an effect. None of these primary comparison statistics is reported in the registry record, so those interpretations cannot be made for this trial from the posted information.
The available safety counts are separate from the efficacy endpoint. The registry records 0 serious adverse events among 200 participants at risk in the rizatriptan group and 0 among 97 at risk in the placebo group. It also records 30 other adverse events among 200 at risk in the rizatriptan group and 4 among 97 at risk in the placebo group. These are counts in different adverse-event categories; they are not the primary nausea results and do not supply an efficacy estimate. No rates or comparative safety effects are calculated.
Thus, the strongest interpretation is descriptive: the registry identifies a completed randomized trial, its intervention and comparator, and a defined two-hour nausea endpoint, but does not report the primary comparison needed to judge its observed result or precision.
9. Statistical Methods Explained
For a binary endpoint, each participant is classified according to whether the stated event occurred. In this trial the event was reporting no nausea at 2 hours after treatment. A group-level comparison would ordinarily use the number meeting that definition and the corresponding number assessed in each group. The registry record does not report those primary endpoint counts or denominators, so no numerical comparison can be reproduced.
What does a confidence interval convey?
In general, a confidence interval expresses uncertainty around an estimated effect. A narrower interval indicates greater precision under the model and assumptions used; a wider interval indicates greater uncertainty. The interval may include values consistent with effects in different directions or with little difference, depending on its position and width. These are general interpretations, not findings from this trial: no primary effect estimate or confidence interval is reported in the registry record.
What does a significance test convey?
In general, a significance test compares the observed data with a null hypothesis under a statistical model. A p-value is not the probability that the null hypothesis is true, and it does not describe how large or important an effect is. Interpretation also depends on the analysis population, endpoint definition, and prespecified method. The registry record lists no analyses and does not report a primary-outcome p-value or a statistical plan, so significance cannot be assessed from the posted results.
Why does the binary outcome definition matter?
Turning a symptom assessment into an absence-or-presence endpoint gives a clear threshold for counting participants, but it also discards information about symptom severity and changes between assessments. The specified assessment was at 2 hours after treatment; the endpoint therefore concerns status at that time, not the entire symptom trajectory. The registry does not report other primary endpoint time points or detailed measurement rules beyond the electronic-diary absence definition.
How should planning calculations be read?
The record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It describes the target effect as a stated fraction of the observed effect. These assumptions describe an illustration, not necessarily the trial's design or analysis. The record does not report the trial's own sample-size justification, and the numerical planning results and the effect fraction are not reported in the registry record. A planning sample size is not observed power and does not substitute for an estimate and uncertainty interval from trial results.
For binary data, methods generally compare event counts while accounting for the number assessed in each group. The choice of effect measure and method can affect the estimate and its uncertainty, particularly when event counts are small or absent. Without the primary counts, denominators, and analysis method, it is not possible to determine what method was used or to recalculate the sponsor's comparison. The record contains no sponsor analysis result to compare with any recalculation.
Safety counts also require denominators and clear category definitions. The registry presents counts at risk and counts with serious or other adverse events by arm. A count alone does not establish comparative risk, and the serious-event counts should not be combined with the other-event counts without knowing whether categories overlap and how they were collected. No such combined calculation is made.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures: elimination of nausea at 2 hours as the primary outcome and pain relief at 2 hours as a secondary outcome. It does not report results for either outcome in the record, nor does it provide an analysis plan explaining how multiple outcomes or tests were handled. The number of analyses recorded is 0. This does not establish whether analyses were conducted outside the registry; it means their results and methods are not reported in the registry record.
Multiplicity is a general concern when several outcomes, time points, subgroups, or statistical tests are examined. Without a prespecified approach, the chance of a nominally notable finding can be difficult to interpret across multiple tests. The registry does not report a multiplicity adjustment or a hierarchy of testing beyond identifying the nausea outcome as primary and pain relief as secondary. No adjustment should be assumed.
The Full Analysis Set was defined as randomized and treated participants with at least one assessment within 2 hours after treatment, following baseline assessment. The registry does not report how missing post-treatment assessments were handled, whether any participants were excluded from this population, or whether sensitivity analyses were conducted. It also does not report an intention-to-treat or per-protocol analysis population. Therefore, the effect of missing outcome data and the robustness of any analysis cannot be evaluated from the registry record.
11. 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 |
|---|---|---|---|
| Rizatriptan 10 mg | 0 | 200 | 0.0% |
| Placebo | 0 | 97 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Rizatriptan 10 mg | 30 of 200 |
| Placebo | 4 of 97 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Rizatriptan 10 mg | Placebo |
|---|---|---|---|
| Dizziness | Nervous system disorders | 4 of 200 | 1 of 97 |
| Somnolence | Nervous system disorders | 4 of 200 | 0 of 97 |
| Vision blurred | Eye disorders | 2 of 200 | 0 of 97 |
| Diarrhoea | Gastrointestinal disorders | 2 of 200 | 0 of 97 |
| Dry mouth | Gastrointestinal disorders | 2 of 200 | 0 of 97 |
| Nausea | Gastrointestinal disorders | 2 of 200 | 0 of 97 |
| Paraesthesia oral | Gastrointestinal disorders | 2 of 200 | 0 of 97 |
| Vomiting | Gastrointestinal disorders | 2 of 200 | 0 of 97 |
| Fatigue | General disorders | 1 of 200 | 1 of 97 |
| Peripheral coldness | General disorders | 2 of 200 | 0 of 97 |
The registry reports serious adverse event counts separately from other adverse events. In the rizatriptan 10 mg group, 0 serious adverse events were recorded among 200 participants at risk, and 30 other adverse events were recorded among 200 at risk. In the placebo group, 0 serious adverse events were recorded among 97 participants at risk, and 4 other adverse events were recorded among 97 at risk.
These are counts, not comparative estimates. The number at risk is the denominator associated with each category in the record, but no rates, confidence intervals, or statistical tests are reported. The serious-event counts do not show that serious events are impossible; they describe what the registry reports for these groups. The record lists no serious adverse event terms. Death counts are not reported in the registry record.
The serious and other adverse-event categories should be read separately. The record does not explain whether participants could appear in more than one adverse-event category, provide event-level detail, or describe the collection and coding procedures. These figures do not answer the primary question about nausea elimination and should not be treated as a complete assessment of safety.
12. What the Result Does, and Does Not, Mean
This trial record documents a randomized, double-blind, placebo-controlled comparison of rizatriptan ODT and matching placebo in people with migraine-associated nausea. It specifies a primary endpoint based on participant-reported absence of nausea at 2 hours after treatment and identifies the Full Analysis Set used for that endpoint. These details clarify what the trial was designed to compare.
However, the registry record does not report the primary outcome counts, a treatment-effect estimate, its uncertainty, or an inferential analysis. It therefore cannot show how the two groups compared on the primary endpoint or how precisely any observed difference was estimated. The completed status and enrollment figure do not fill that results gap. Nor can the safety counts be used as a substitute for the efficacy comparison.
In general, an outcome at a single assessment time does not describe whether symptom changes were sustained or how symptoms behaved at other times. The endpoint definition also does not measure severity beyond the presence or absence of nausea at the specified assessment. The registry provides no additional primary endpoint details that would support broader conclusions about symptom course.
The record can support a description of the study design, population definition, outcome, and posted adverse-event counts. It cannot support a conclusion about the size or direction of the primary treatment effect, its statistical significance, or its precision. These limits concern what is reported in the registry record; they are not evidence for either a positive or a negative treatment result.
13. Why This Trial Matters Statistically
Statistically, the record illustrates why a clearly named endpoint is not enough to interpret a trial's findings. The nausea outcome has a defined assessment time, an explicit absence criterion, and a stated analysis population. Those features make the intended measurement understandable. But without event counts, denominators, an effect estimate, and uncertainty, the primary comparison itself cannot be evaluated.
The defined Full Analysis Set also matters: the registry enrollment figure and the endpoint population are not interchangeable. Only participants meeting the endpoint population definition were included in that set, and the record does not report the resulting arm-specific denominators. This distinction is important when interpreting any group-level count or estimating how much information the analysis contains.
The safety reporting shows another basic statistical distinction. Counts of serious and other adverse events describe separate recorded categories, while comparative interpretation requires attention to denominators, definitions, and uncertainty. The registry supplies some counts and risk-group sizes, but not the analyses or detail needed for a fuller comparison.
Finally, the stated planning assumptions should not be mistaken for the trial's own statistical plan or for evidence about the observed result. Planning illustrations and completed-trial estimates answer different questions. The record's central statistical limitation is that it describes the trial and its intended outcome but does not report the primary analysis needed to quantify the comparison.
14. 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 principal limitation for interpreting this specific trial from its registry record is the absence of numerical primary-outcome results. The record does not report how many participants in either arm had elimination of nausea at 2 hours, the corresponding analysis denominators, or an effect estimate and uncertainty interval. It also lists no analyses.
The enrollment figure is not broken down by arm for the primary outcome. Although the Full Analysis Set is defined, its group sizes and the handling of participants without the required assessment are not reported. The registry also does not describe missing-data methods, sensitivity analyses, or other analysis populations.
The record identifies a secondary pain-relief outcome but does not report its result or explain a multiplicity strategy. It does not provide the randomization procedure, allocation ratio, detailed masking procedures, or the trial's own sample-size justification. Interim analyses and the full statistical plan are not reported in the registry record.
Safety reporting is limited to counts at risk and counts with serious or other adverse events. Serious adverse event terms are not listed, and death counts are not reported in the registry record. Event definitions, participant-level overlap between categories, and comparative safety analyses are also absent. These reporting limits prevent a fuller appraisal of either the primary outcome or the safety profile using this record alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea — NCT00250458.
- Registry record last updated 2022-02-03; status last verified 2022-02.
- Results first posted 2010-06-23.
- 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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18. Record Summary
The registry describes NCT00250458, a completed Phase 3 randomized, double-blind, placebo-controlled, parallel-group study of rizatriptan ODT versus matching placebo for migraine-associated nausea. Enrollment is listed as 346; the recorded start is 2006-03 and primary completion is 2006-10. The sponsor is Organon and Co.
The primary endpoint was participants reporting no nausea at 2 hours after treatment, recorded in an electronic diary. Its population was the Full Analysis Set, defined as randomized and treated participants with at least one post-baseline assessment within 2 hours after treatment. Pain relief at 2 hours was listed as a secondary outcome.
The registry record does not report numerical primary or secondary outcome results, an analysis, or the primary comparison's precision. It reports serious and other adverse-event counts by group, but does not report deaths. The design and endpoint are described; the main efficacy result is not reported in the registry record.