Trial · NCT00573170
TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults
NCT00573170, Phase 3, Completed, GlaxoSmithKline; results first posted 2010-12-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults. Trials, record NCT00573170. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00573170
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults
- NCT number
- NCT00573170
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 375 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Migraine Disorders, Migraine, Acute
- Interventions
- TREXIMET®, Butalbital-containing Combination Medications (BCM), placebo
- First posted
- 2007-12-14
- Last updated
- 2010-12-29
- Results first posted
- 2010-12-29
- Limitations and caveats
Enrolled participants included all those entering the screening part of the study. Randomized participants included only those who completed screening and completed the 2-week butalbital wash-out, and were successfully randomized to study drug.
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose | From 2 to 24 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | SPF 2-24 hours is defined for all participants as having no pain at 2 hours post-dose and without the return of any pain or the use of any rescue medication (any medication taken after the first dose of study medication for any migraine pain or symptoms) from 2-24 hours. |
| Secondary | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Pain-Free is defined as having no pain and without the use of any rescue medication from the time of the initial dose of study medication for a particular migraine attack until the defined time point at 2, 4, 6, 8, 24 or 48 hours post-dose. |
| Secondary | Number of Participants Using Rescue Medication Within 48 Hours Post Dose | From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Number of participants who took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it. |
| Secondary | Mean Time to First Use of Rescue Medication for the First Attack Treated With Study Medication (Attack 1) | From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for the first migraine attack treated. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it. |
| Secondary | Mean Time to First Use of Rescue Medication for the Second Attack Treated With Study Medication (Attack 2) | From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for their second migraine attack treated in the study. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it. |
| Secondary | Mean Time to First Use of Rescue Medication for the Third Attack Treated With Study Medication (Attack 3) | From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for their third migraine attack treated in the study. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it. |
| Secondary | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Migraine-free is defined as pain-free with no migraine-associated symptoms (nausea, vomiting, photophobia \[sensitivity to light\], and phonophobia \[sensitivity to sound\]) with use of any rescue medication before the defined time point. |
| Secondary | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | The number of participants with no pain and relief of nausea in those participants for whom nausea was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point. |
| Secondary | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | The number of participants with no pain and relief of photophobia in those participants for whom photophobia was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point. |
| Secondary | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | The number of participants with no pain and relief of phonophobia in those participants for whom phonophobia was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose | From 2 to 24 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Intent-to-Treat (ITT) Population: all participants who were treated with investigational product and provided at least one post-dose efficacy assessment . Participants may have been included in one, two, or all of the Placebo, Treximet and Butalbital-containing combination medication arms due to the cross-over nature of the study design. | participants | NUMBER |
| SECONDARY | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants Using Rescue Medication Within 48 Hours Post Dose | From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | ITT Population | participants | NUMBER |
| SECONDARY | Mean Time to First Use of Rescue Medication for the First Attack Treated With Study Medication (Attack 1) | From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Participants in the ITT population who treated migraine Attack 1 with study medication and then used migraine rescue medication after dosing. | hours | MEAN |
| SECONDARY | Mean Time to First Use of Rescue Medication for the Second Attack Treated With Study Medication (Attack 2) | From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Participants in the ITT population who treated migraine Attack 2 with study medication and then used migraine rescue medication after dosing. | hours | MEAN |
| SECONDARY | Mean Time to First Use of Rescue Medication for the Third Attack Treated With Study Medication (Attack 3) | From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Participants in the ITT population who treated migraine Attack 3 with study medication and then used migraine rescue medication after dosing. | hours | MEAN |
| SECONDARY | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | ITT Population - including only those participants who reported nausea at dose time. | participants | NUMBER |
| SECONDARY | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | ITT Population - including only those participants who reported photophobia at dose time. | participants | NUMBER |
| SECONDARY | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | ITT Population - including only those participants who reported phonophobia at dose time. | participants | NUMBER |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group276
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose | Placebo | 10 | participants | ||
| Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose | Treximet | 26 | participants | ||
| Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose | Butalbital-containing Combination Medication | 18 | participants | ||
| Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | Placebo | 2 hours post-dose | 16 | participants | |
| Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | Treximet | 2 hours post-dose | 45 | participants | |
| Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | Butalbital-containing Combination Medication | 2 hours post-dose | 26 | participants | |
| Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | Placebo | 4 hours post-dose | 21 | participants | |
| Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | Treximet | 4 hours post-dose | 86 | participants | |
| Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | Butalbital-containing Combination Medication | 4 hours post-dose | 39 | participants | |
| Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | Placebo | 6 hours post-dose | 29 | participants |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 results by groupParticipant flow90
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Treatment Period | STARTED | Treximet, Placebo, Butalbital-containing Combo. Medication | 64 | |
| First Treatment Period | STARTED | Treximet, Butalbital-containing Combo. Medication, Placebo | 60 | |
| First Treatment Period | STARTED | Butalbital-containing Combo. Medication, Treximet, Placebo | 60 | |
| First Treatment Period | STARTED | Butalbital-containing Combo. Medication, Placebo, Treximet | 66 | |
| First Treatment Period | STARTED | Placebo, Treximet, Butalbital-containing Combo. Medication | 63 | |
| First Treatment Period | STARTED | Placebo, Butalbital-containing Combo. Medication, Treximet | 62 | |
| First Treatment Period | COMPLETED | Treximet, Placebo, Butalbital-containing Combo. Medication | 64 | |
| First Treatment Period | COMPLETED | Treximet, Butalbital-containing Combo. Medication, Placebo | 60 | |
| First Treatment Period | COMPLETED | Butalbital-containing Combo. Medication, Treximet, Placebo | 60 | |
| First Treatment Period | COMPLETED | Butalbital-containing Combo. Medication, Placebo, Treximet | 66 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 participant flowAdverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo | 8 | 405 | |
| other | Nausea | Gastrointestinal disorders | Treximet | 8 | 406 | |
| other | Nausea | Gastrointestinal disorders | Butalbital-containing Combination Medication | 2 | 392 | |
| serious | Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo | 0 | 405 | |
| serious | Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Treximet | 1 | 406 | |
| serious | Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Butalbital-containing Combination Medication | 0 | 392 | |
| serious | Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo | 1 | 405 | |
| serious | Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Treximet | 0 | 406 | |
| serious | Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Butalbital-containing Combination Medication | 0 | 392 | |
| serious | Chest pain | General disorders | Placebo | 0 | 405 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Treximet | ||
| Total, all-cause mortality | Butalbital-containing Combination Medication | ||
| Total, other adverse events | Placebo | 8 | 405 |
| Total, other adverse events | Treximet | 8 | 406 |
| Total, other adverse events | Butalbital-containing Combination Medication | 2 | 392 |
| Total, serious adverse events | Placebo | 1 | 405 |
| Total, serious adverse events | Treximet | 2 | 406 |
| Total, serious adverse events | Butalbital-containing Combination Medication | 0 | 392 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00573170
GET https://conductscience.org/api/trials/v1/NCT00573170/registered?page=2