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 "Completeness of Response" Following Treatment With Treximet™ for Migraine (NCT00893737), a na phase 4 study. The primary outcome is Change in Scores From Completeness of Response Survey (CORS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00893737 |
| Phase | Phase 4 |
| Condition | Migraine |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 147 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cady, Roger, M.D. |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled participants with migraine at 8 investigative sites. The registry records an enrollment of 147. It does not report detailed eligibility criteria or participant characteristics, so the enrolled group cannot be characterized further from this record.
Intervention
Participants used Treximet, a combination of sumatriptan succinate 85 mg and naproxen sodium 500 mg. The treatment description says one tablet was to be taken as soon as a participant had a headache indicative of migraine, with treatment of up to 16 attacks during the 2-month study period.
Comparator
The comparison was each participant’s usual pre-study triptan, considered at Visit 1, versus Treximet, considered at Visit 2. This is a before-and-after comparison within one group, not a randomized comparison between concurrent treatment groups.
Primary question
The primary question was whether Completeness of Response Survey scores differed between usual pre-study triptan and Treximet across pain, associated symptoms, limbic or affective symptoms, and speed of return to functionality. The record says higher scores represent better treatment efficacy, but does not report the observed score changes or their uncertainty.
3. Trial Design
This was a completed Phase 4, open-label, single-group study. The registry identifies no allocation to separate arms and no masking. Its enrollment was 147, and the listed study dates run from 2009-06 to primary completion in 2010-01. The sponsor is Cady, Roger, M.D. The registry’s brief description says participants enrolled at 8 investigative sites and completed 2 visits.
At Visit 1, described as screening, participants completed a Completeness of Response Survey about their usual migraine medication, a triptan. At Visit 2, following the 2-month treatment period, they completed the survey about the study medication, Treximet. The intervention description specifies one tablet at the onset of a headache indicative of migraine and treatment of up to 16 attacks during that period.
The design therefore uses participants as their own reference over time. That feature can make the two observations for an individual naturally paired, but it does not make the comparison randomized or blinded. The earlier assessment concerns usual pre-study treatment, while the later one concerns the study treatment; treatment, assessment time, and study context differ together. The record does not report a concurrent control group, a washout period, or other details that would resolve those design considerations.
Two secondary outcomes are listed: the percent of participants reporting a therapeutic advantage of Treximet over their usual pre-study triptan, and a paired t-test assessing greater subject satisfaction with Treximet using the Revised Patient Perception of Migraine Questionnaire. Results for these outcomes are not reported in the registry record.
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.
Overall Study
| Stage | Treximet |
|---|---|
| STARTED | 147 |
| COMPLETED | 135 |
| NOT COMPLETED | 12 |
Reasons for not completing this period:
| Reason | Treximet |
|---|---|
| Adverse Event | 4 |
| Withdrawal by Subject | 2 |
| Lost to Follow-up | 6 |
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 | Treximet |
|---|---|---|
| Participants analysed | 147 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 145 |
| Age, Categorical: >=65 years | Participants | 2 |
| Age Continuous | years | 44.3 (SD 11.0) |
| Sex: Female, Male: Female | Participants | 128 |
| Sex: Female, Male: Male | Participants | 19 |
| Region of Enrollment: United States | participants | 147 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Scores From Completeness of Response Survey (CORS), measured over Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in scores from the Completeness of Response Survey, comparing the usual pre-study triptan assessment at Visit 1 with the Treximet assessment at Visit 2. The registry describes scores in four areas: Pain, scored from 0-4; Associated Symptoms, scored from 0-4; Limbic/Affective Symptoms, scored from 0-5; and Speed of Return to Functionality, scored from 1-5. It states that higher scores represent better treatment efficacy.
These domains address more than pain alone. They include associated symptoms, affective or limbic symptoms, and the return to ordinary functionality, which the registry describes as outcomes relevant to patients. Considering several domains can describe different aspects of a participant’s reported response rather than reducing the assessment to one symptom.
The registry labels the endpoint as a mean and identifies a 95% confidence interval as its dispersion measure. However, it does not report the means, confidence intervals, or numerical changes for any domain. Nor does the record explain how a combined score, if any, would be constructed. The stated visit timing makes the comparison a within-participant assessment over the treatment period, but the primary analysis method and the precise handling of incomplete surveys are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the intended comparison but does not report the numerical findings needed to judge its size or precision. There are no posted mean score changes, confidence intervals, or p-values for the primary outcome, and the record lists no analyses. As a result, the magnitude and direction of the observed score changes cannot be described from this record. It is also not possible to assess whether any apparent change was estimated precisely or whether the data were compatible with a range of effects.
The endpoint description says that higher Completeness of Response Survey scores represent better treatment efficacy. That statement clarifies how scores are intended to be interpreted; it is not itself a report that scores increased. Without the actual results, the registry does not establish whether scores differed between the usual pre-study triptan and Treximet assessments, in which domains they differed, or how uncertain any difference was.
The design further shapes what a comparison can mean. Participants were assessed about their usual triptan at Visit 1 and about Treximet at Visit 2. Because there was no randomized, masked concurrent comparison group, a change between visits cannot be separated from other differences between the pre-study and study periods using the design description alone. Participants knew which medication they were considering, and the two assessments refer to different treatment contexts. These are design features, not findings about the participants’ responses.
The registry lists secondary questions about perceived therapeutic advantage and satisfaction, including a paired t-test for the satisfaction outcome. Their results are not reported. The primary analysis method, outcome-specific analysis population, and treatment of missing data are also not reported in the registry record. Those omissions limit evaluation of how the stated questions were answered.
Safety entries are descriptive counts rather than evidence of a treatment effect. The record lists 2 participants with serious adverse events and 28 with other adverse events, each among 147 at risk in the Treximet group. It also lists pneumonia and migraine without aura among the serious-event terms, each at 0.7%. These entries do not by themselves establish whether an event was caused by treatment, and the record does not report a death count.
Overall, the record describes a patient-reported before-and-after study and its intended measures, but it does not provide results with which to quantify response or compare the precision of estimates. No conclusion about the direction, size, or statistical certainty of the primary or secondary outcomes can be drawn from the registry results described.
9. Statistical Methods Explained
The endpoint is described as a mean of a continuous measure, with a 95% confidence interval. A mean summarizes the central level of scores across participants. A confidence interval expresses statistical uncertainty around an estimated quantity under the assumptions of the analysis. In general, a narrower interval indicates greater precision, while a wider interval indicates less precision. It does not describe the range of individual participants’ scores, and it is not a statement that a particular participant’s score lies within the interval. The registry record does not include the estimates or intervals for this study’s CORS outcomes.
What does a within-participant comparison involve?
When the same participant contributes an assessment under each of two conditions, the two observations are related. A paired analysis uses the within-person differences rather than treating all observations as independent. In general, pairing can account for stable differences between people, because each participant serves as their own reference. The usual pre-study triptan assessment and the later Treximet assessment create this kind of repeated-measure structure in principle. However, the registry does not report the primary analysis method, so it cannot be assumed that a particular paired procedure was used for the CORS endpoint.
A paired t-test is explicitly named for a secondary satisfaction outcome based on the Revised Patient Perception of Migraine Questionnaire. In general, a paired t-test evaluates the average within-person difference and relies on assumptions about the distribution of those differences. The registry’s listing of that test applies to the stated secondary outcome; it does not establish the method used for the primary CORS scores. No test statistic, estimated difference, confidence interval, or p-value for the secondary outcome is reported.
How should a confidence interval be read?
In general, a confidence interval gives a range of values compatible with the observed estimate under the statistical model and its assumptions. It helps readers assess precision alongside the estimate itself. A confidence interval does not remove uncertainty about bias, measurement, missing observations, or the relevance of the study design. Here, the registry specifies 95% confidence intervals as the dispersion measure for the primary endpoint but does not post the intervals. Their width and relation to any meaningful benchmark therefore cannot be assessed.
The four CORS domains use different stated score ranges: Pain and Associated Symptoms each range from 0-4, Limbic/Affective Symptoms from 0-5, and Speed of Return to Functionality from 1-5. A numerical change needs to be interpreted in the context of the relevant domain and its scale. Because no changes are reported, it is not possible to characterize their size or compare their precision. The record does not report a threshold for a clinically important change.
What do the planning assumptions mean?
The registry’s planning illustration is described as based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These are assumptions for a hypothetical planning exercise, not a description of the single-group study’s allocation. The study itself is listed as having no allocation and one group. The record does not report the observed effect or numerical planning estimates, so no sample-size value can be interpreted from the information recorded.
In general, a planning calculation asks how many participants might be needed to detect a specified effect under chosen assumptions. A planning illustration based on a fraction of an observed effect is not observed power, and it does not show what the completed trial established. The registry notes that non-time-to-event illustrations use participants per arm; the planning setup’s equal allocation between two arms should not be mistaken for the actual study design. The record does not report the trial’s own sample-size justification.
Why can over-dispersion matter?
In general, over-dispersion occurs when observed variability is greater than a model assumes. If it is ignored in a setting where it applies, uncertainty estimates can be too small. This is a general statistical consideration, not a claim about this study: the registry does not report a model or diagnostic information showing whether over-dispersion was relevant to these continuous CORS scores.
More broadly, interpreting a statistical result requires the estimate, its uncertainty, the analysis method, and the design context. The registry record describes some endpoint details and one secondary test but does not report outcome analyses. The statistical methods and assumptions actually used for the primary comparison are therefore not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The study lists four CORS domains for its primary outcome and two secondary outcomes. Evaluating several outcomes creates a general multiplicity consideration: the more questions tested, the greater the chance that at least one result may appear unusual by chance if each is assessed separately. Statistical approaches can address this, for example by adjusting significance thresholds or by defining a hierarchy of outcomes. The registry record does not report whether any multiplicity strategy was planned or used, so no adjustment should be assumed.
Missing-data methods can also affect estimates. Participants might have an assessment missing, or a questionnaire might be incomplete; statistical plans commonly specify how such cases are handled and which observations contribute to each analysis. The record does not report the amount or pattern of missing CORS or satisfaction data, any imputation procedure, or a sensitivity analysis. It therefore does not establish whether all enrolled participants contributed to each outcome.
The registry records enrollment of 147, but the analysis populations for the primary and secondary outcomes are not reported in the registry record. It is not stated whether analyses included all enrolled participants, only participants with assessments at both visits, or another defined group. The distinction matters when interpreting a mean change or a paired test, because such analyses require appropriate observations from the relevant participants.
Although the secondary satisfaction outcome names a paired t-test, this does not supply the analysis plan for the primary CORS endpoint or resolve missing-data and multiplicity questions. The registry lists no outcome analyses, and results addressing these issues are not reported.
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 |
|---|---|---|---|
| Treximet | 2 | 147 | 1.4% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Treximet | 28 of 147 |
Most frequent serious adverse event terms
| Event term | Organ system | Treximet |
|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 1 of 147 |
| Migraine without aura | Nervous system disorders | 1 of 147 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treximet |
|---|---|---|
| Nausea | Gastrointestinal disorders | 9 of 147 |
| Dizziness | Nervous system disorders | 5 of 147 |
| Sleepy | Nervous system disorders | 5 of 147 |
| Chest Tightness | General disorders | 4 of 147 |
| Light Headed | Nervous system disorders | 4 of 147 |
| Tired | Nervous system disorders | 4 of 147 |
| Jittery | General disorders | 3 of 147 |
Serious events with the highest arm-level rate: pneumonia (0.7%), migraine without aura (0.7%).
The registry lists the Treximet group with 147 participants at risk for serious adverse events and 2 affected. For other adverse events, it lists 147 at risk and 28 affected. These are reported counts; the record does not provide additional details about event timing, duration, severity beyond the serious classification, or how many events each participant experienced.
The serious-event terms listed are pneumonia and migraine without aura, each reported at 0.7%. The registry record does not give further case details or establish whether these events were considered related to Treximet. An event occurring during a study is not, by itself, evidence that the study medication caused it.
The death count is not reported in the registry record. It should not be interpreted as zero. The safety entries are limited to the recorded group and do not provide a comparison with a concurrent control group, consistent with the single-group design. They are descriptive reporting, not a basis for estimating a comparative safety effect.
12. What the Result Does, and Does Not, Mean
This record describes a study designed to examine patient-reported Completeness of Response Survey scores before and after a treatment-period change from participants’ usual pre-study triptan to Treximet. The domains include pain, associated symptoms, limbic or affective symptoms, and speed of return to functionality. The stated direction of the scale is that higher scores represent better treatment efficacy.
The record does not report the outcome values. It therefore does not show whether any domain’s mean score increased or decreased, how large a change was observed, or how precise an estimate might be. It also does not report results for the listed secondary questions about perceived therapeutic advantage and satisfaction. The study’s enrollment and endpoint description cannot substitute for those missing estimates.
The design is not a randomized comparison between treatment groups. It compares two assessments from a single group at different visits, with participants considering their usual triptan at the earlier visit and Treximet at the later visit. The open-label approach means participants were not masked to the study medication. These features should be considered when interpreting any change, but the absence of posted results means the change itself cannot be characterized.
The serious and other adverse-event counts describe entries in the Treximet group. They do not establish causation or provide a comparative estimate. More generally, neither an endpoint definition nor a planning illustration establishes what the participants experienced. The registry record gives the intended questions and some safety counts, but the outcome analyses necessary to judge efficacy estimates and their uncertainty are not reported.
13. Why This Trial Matters Statistically
Statistically, the study is useful to consider because it asks about patient-reported dimensions beyond pain alone. Its CORS domains include associated symptoms, limbic or affective symptoms, and return to functionality, as well as pain. That makes the choice of measurement part of the scientific question: a study’s conclusions depend not only on its treatment comparison but also on what outcomes it measures and how those outcomes are reported.
The repeated assessments also illustrate an important design distinction. A within-participant comparison can use each participant’s earlier response as a reference, but it is not equivalent to a randomized, concurrent control comparison. In this study, the usual pre-study triptan assessment and Treximet assessment took place at different visits and in an open-label setting. Those features shape the interpretation of any observed difference.
The record is also a reminder that an endpoint definition is not a result. It specifies score domains, score ranges, and the intended direction, yet no mean changes or confidence intervals are reported. Without estimates and uncertainty, readers cannot judge magnitude, precision, or consistency across domains. The listed secondary outcomes similarly remain questions without posted results.
Finally, planning assumptions should be distinguished from the completed study’s design and findings. The planning illustration assumes equal allocation between two arms, whereas the study is recorded as a single group. It is a planning framework, not evidence of observed power or a report of what the study found. These distinctions help keep design, analysis, and results separate when reading registry records.
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 design is open-label and single-group, with no randomized concurrent control. Participants assessed their usual pre-study triptan at Visit 1 and Treximet at Visit 2, so the treatment comparison is linked to a change in assessment time and context. The record does not describe procedures that would separate those influences.
The registry reports an enrollment of 147 but does not report participant characteristics, detailed eligibility criteria, or the number contributing to each endpoint analysis. This limits assessment of who the results might represent and whether the analyzed participants differed from those enrolled. The handling and extent of missing survey data are not reported in the registry record.
Outcome reporting is incomplete for interpretation: no CORS means, changes, confidence intervals, or primary analysis results are reported, and no results are listed for the secondary outcomes. The primary statistical method, multiplicity approach, analysis populations, and sensitivity analyses are not reported in the registry record. The record also does not report a threshold for clinically important change or explain how multiple domains were treated in the analysis.
Safety reporting is limited to counts and two serious-event terms. The record does not provide event-level details or a death count, and the single-group design supplies no concurrent safety comparison. These limitations concern what can be established from the registry record; they do not determine what the full study may have reported elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: "Completeness of Response" Following Treatment With Treximet™ for Migraine — NCT00893737.
- Registry record last updated 2011-01-25; status last verified 2011-01.
- Results first posted 2011-01-25.
- 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 record describes a completed Phase 4, open-label, single-group study of Treximet for migraine, with enrollment of 147. Participants assessed their usual pre-study triptan at Visit 1 and Treximet at Visit 2 after a 2-month treatment period. The primary outcome was change in CORS scores across pain, associated symptoms, limbic or affective symptoms, and speed of return to functionality. Higher scores are described as better treatment efficacy.
The record lists two secondary outcomes and reports serious and other adverse-event counts in the Treximet group. It does not report primary or secondary outcome analyses, score changes, confidence intervals, or a death count. The resulting record describes the study questions and design, but does not provide the numerical findings needed to assess outcome magnitude or precision.