Trial · NCT00387881
TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)
NCT00387881, Phase 3, Completed, GlaxoSmithKline; results first posted 2009-07-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1). Trials, record NCT00387881. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00387881
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)
- NCT number
- NCT00387881
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 679 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Migraine, Without Aura
- Interventions
- sumatriptan succinate / naproxen sodium, Placebo
- First posted
- 2006-10-13
- Last updated
- 2016-12-16
- Results first posted
- 2009-07-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. | 2 hours through 24 hours after Treatment | Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine. |
| Secondary | Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment | 0.5, 1, and 4 hours after Treatment | Pain-Free is defined as post-treatment headache pain severity of none in subjects who have not used rescue medication prior to or at the time of the assessment. |
| Secondary | Sustained Headache Relief 2-24 Hours After Treatment | 2-24 hours after treatment | Sustained pain relief was defined as having pain relief (mild or no pain) at 2 hours w/o any moderate or severe pain during 2-24 hour period post-treatment, without rescue medication. |
| Secondary | Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment | 0.5, 1, 2, and 4 hours after treatment | Pain relief was defined as reduction of headache pain from a baseline severity of moderate or severe to none or mild at the given time. |
| Secondary | Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment | 0 - 24 hours after treatment | Rescue medication defined as additional medication (i.e. sumatriptan/naproxen sodium as open-label rescue or other medication as permitted per protocol), taken by subject for the treatment of headache pain or other symptoms associated with the headache attack. |
| Secondary | Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment | 1-2, and 2- 4 hours after treatment | Intermediate sustained pain relief was defined as achieving headache pain relief (from moderate or severe pain at baseline to mild or no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours). (Intermediate=Intermed.) |
| Secondary | Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours | 1-2 and 2-4 hours after treatment | Intermediate sustained pain free was defined as achieving headache pain-free (moderate or severe pain to no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours).(Intermediate=Intermed.) |
| Secondary | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | 2 and 4 hours after treatment | Neck pain, sinus pain, photophobia, phonophobia and nausea are considered headache-associated symptoms.(Headache-associated=Headache-Assoc.) |
| Secondary | Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score | 0 - 24 hours after treatment | Patient Perception of Migraine Questionnaire-Revised(PPMQ-R) evaluates subject satisfaction with treatment 24 hours post-dose using validated questions. Questions are analyzed on 4 subscale scores (efficacy, functionality, ease-of-use, and tolerability) and total score. Scores range from 0-100, with the higher scores indicating better satisfaction. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. | 2 hours through 24 hours after Treatment | The Intent to Treat (ITT) Population was the primary analysis population for assessing efficacy and included subjects who treated at least 1 headache attack with randomized treatment and provided at least one post dose evaluation. | Participants | NUMBER |
| SECONDARY | Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment | 0.5, 1, and 4 hours after Treatment | ITT Population | Participants | NUMBER |
| SECONDARY | Sustained Headache Relief 2-24 Hours After Treatment | 2-24 hours after treatment | ITT Population | Participants | NUMBER |
| SECONDARY | Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment | 0.5, 1, 2, and 4 hours after treatment | ITT Population | Participants | NUMBER |
| SECONDARY | Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment | 0 - 24 hours after treatment | ITT Population | Participants | NUMBER |
| SECONDARY | Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment | 1-2, and 2- 4 hours after treatment | ITT Population | Participants | NUMBER |
| SECONDARY | Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours | 1-2 and 2-4 hours after treatment | ITT Population | Participants | NUMBER |
| SECONDARY | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | 2 and 4 hours after treatment | ITT Population | Participants | NUMBER |
| SECONDARY | Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score | 0 - 24 hours after treatment | ITT Population - Actual numbers of subjects who took questionnaire were Placebo 199 and Sumatriptan/Naproxen=188 | Score in scale | MEAN |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. | Placebo | Pain-Free (2 hours) | 25 | Participants | |
| Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. | Sumatriptan/Naproxen | Pain-Free (2 hours) | 64 | Participants | |
| Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. | Placebo | Sustained Pain-Free (2-24 hours) | 20 | Participants | |
| Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. | Sumatriptan/Naproxen | Sustained Pain-Free (2-24 hours) | 54 | Participants | |
| Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment | Placebo | Pain-free at 4 hours | 60 | Participants | |
| Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment | Sumatriptan/Naproxen | Pain-free at 4 hours | 105 | Participants | |
| Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment | Placebo | Pain-free at 1 hour | 16 | Participants | |
| Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment | Sumatriptan/Naproxen | Pain-free at 1 hour | 23 | Participants | |
| Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment | Placebo | Pain-free at 0.5 hour | 6 | Participants | |
| Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment | Sumatriptan/Naproxen | Pain-free at 0.5 hour | 5 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 334 | |
| Overall Study | STARTED | Sumatriptan/Naproxen | 345 | |
| Overall Study | COMPLETED | Placebo | 245 | |
| Overall Study | COMPLETED | Sumatriptan/Naproxen | 243 | |
| Overall Study | NOT COMPLETED | Placebo | 89 | |
| Overall Study | NOT COMPLETED | Sumatriptan/Naproxen | 102 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Sumatriptan/Naproxen | ||
| Total, other adverse events | Placebo | 0 | 246 |
| Total, other adverse events | Sumatriptan/Naproxen | 0 | 254 |
| Total, serious adverse events | Placebo | 0 | 246 |
| Total, serious adverse events | Sumatriptan/Naproxen | 0 | 254 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sumatriptan/Naproxen vs Placebo: Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment | Trial comparisons |
| Sumatriptan/Naproxen vs Placebo: Sustained Headache Relief 2-24 Hours After Treatment | Trial comparisons |
| Sumatriptan/Naproxen vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00387881
GET https://conductscience.org/api/trials/v1/NCT00387881/results?page=2