Trial · NCT00488514
Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents
NCT00488514, Phase 3, Completed, GlaxoSmithKline; results first posted 2010-09-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents. Trials, record NCT00488514. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00488514
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents
- NCT number
- NCT00488514
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 656 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Migraine Disorders
- Interventions
- Combination Tablet of Treximet (sumatriptan/naproxen sodium)
- First posted
- 2007-06-20
- Last updated
- 2017-05-18
- Results first posted
- 2010-09-06
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With the Indicated Drug-related Adverse Events | Baseline through End of Study (up to Month 12) | The number of participants with a drug-related adverse event (AE). Frequency threshold for reporting a drug-related AE: \>=2% participants recorded as having at least one occurrence of a reported drug-related AE. |
| Secondary | Number of Participants With Any Adverse Event Categorized by Severity | Baseline through End of Study (up to Month 12) | The number of participants with at least one mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities), moderate (an event that is sufficiently discomforting to interfere with normal everyday activities), or severe adverse event (an event that prevents normal everyday activities) was recorded. |
| Secondary | Number of Participants With Any Adverse Event Categorized Over Time | Baseline through End of Study (up to Month 12) | The number of participants with an adverse event occurring in either the first six months of the study (months 0-6; \<=194 days) or the second six months of the study (months 6-12; =\>194 days until end of study) was recorded. |
| Secondary | Number of Participants With Any Adverse Event Categorized by Participant Age | Baseline through End of Study (up to Month 12) | The number of participants with any adverse event by age group (12-14 and 15-17 years) is recorded. |
| Secondary | Number of Participants With Any Adverse Event Categorized by Participant Race | Baseline through End of Study (up to Month 12) | The number of participants with any adverse event was categorized by race. The category "Other" captures : American Indian or Alaskan Native; Asian, Native Hawaiian, or Other Pacific Islander; African American/African Heritage and Asian; African American/African Heritage and White; and American Indian or Alaskan Native and White. |
| Secondary | Number of Participants With Any Adverse Event Categorized by Participant Gender | Baseline through End of Study (up to Month 12) | The number of participants with adverse events by gender is recorded. |
| Secondary | Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet | Baseline through End of Study (up to Month 12) | The number of participants with adverse events that occurred within 3 or 5 days of their first dose of the Combination Tablet was recorded. |
| Secondary | Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet | Baseline through End of Study (up to Month 12) | The number of events that occurred within 3 or 5 days of dosing with the combination tablet on a per tablet basis. A total of 8413, 5876, and 9989 tablets were taken by the 6 Month Completer, 12 Month Completer, and the Safety Populations, respectively. |
| Secondary | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Baseline through End of Study (up to Month 12) | A shift from "normal to low," for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: ALT, 12 years old (y): 0-45 Units/liter (U/L), \>13 y: 0-48 U/L; AST, 12 y: 0-42 U/L, \>13 y 0-42 U/L; creatinine, 12 y: 27-88 micromoles/liter (UMOL/L), \>13 y: 44-124 UMOL/L; potassium, 12 y: 3.5-5.5 millimoles/liter (MMOL/L), \>13 y: 3.5-5.3 MMOL/L; BUN, 12-17 y: 24-101 milligrams (mg)/deciliter (dL). |
| Secondary | Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Baseline through End of Study (up to Month 12) | A shift from "normal to low," for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: hemoglobin, 12-17 years old (y): 120-160 grams (g)/L; hematocrit (expressed as the percentage of blood occupied by red blood cells), 12-17 y: 0.360-0.490. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
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 the Indicated Drug-related Adverse Events | Baseline through End of Study (up to Month 12) | Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet | participants | NUMBER |
| SECONDARY | Number of Participants With Any Adverse Event Categorized by Severity | Baseline through End of Study (up to Month 12) | Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet | participants | NUMBER |
| SECONDARY | Number of Participants With Any Adverse Event Categorized Over Time | Baseline through End of Study (up to Month 12) | Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet | participants | NUMBER |
| SECONDARY | Number of Participants With Any Adverse Event Categorized by Participant Age | Baseline through End of Study (up to Month 12) | Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet | participants | NUMBER |
| SECONDARY | Number of Participants With Any Adverse Event Categorized by Participant Race | Baseline through End of Study (up to Month 12) | Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet | participants | NUMBER |
| SECONDARY | Number of Participants With Any Adverse Event Categorized by Participant Gender | Baseline through End of Study (up to Month 12) | Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet | participants | NUMBER |
| SECONDARY | Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet | Baseline through End of Study (up to Month 12) | Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet | participants | NUMBER |
| SECONDARY | Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet | Baseline through End of Study (up to Month 12) | Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet | tablets | NUMBER |
| SECONDARY | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Baseline through End of Study (up to Month 12) | Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit. | participants | NUMBER |
| SECONDARY | Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Baseline through End of Study (up to Month 12) | Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit. | participants | NUMBER |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group425
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 the Indicated Drug-related Adverse Events | 6 Month Completer Population | At least one drug-related adverse event | 93 | participants | |
| Number of Participants With the Indicated Drug-related Adverse Events | 12 Month Completer Population | At least one drug-related adverse event | 46 | participants | |
| Number of Participants With the Indicated Drug-related Adverse Events | Safety Population | At least one drug-related adverse event | 170 | participants | |
| Number of Participants With the Indicated Drug-related Adverse Events | 6 Month Completer Population | Nausea | 19 | participants | |
| Number of Participants With the Indicated Drug-related Adverse Events | 12 Month Completer Population | Nausea | 11 | participants | |
| Number of Participants With the Indicated Drug-related Adverse Events | Safety Population | Nausea | 44 | participants | |
| Number of Participants With the Indicated Drug-related Adverse Events | 6 Month Completer Population | Dizziness | 7 | participants | |
| Number of Participants With the Indicated Drug-related Adverse Events | 12 Month Completer Population | Dizziness | 3 | participants | |
| Number of Participants With the Indicated Drug-related Adverse Events | Safety Population | Dizziness | 20 | participants | |
| Number of Participants With the Indicated Drug-related Adverse Events | 6 Month Completer Population | Muscle tightness | 10 | participants |
1 to 10 of 425Source ClinicalTrials.gov
See all 425 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 85 mg Sumatriptan/500 mg Naproxen Sodium | 656 | |
| Overall Study | COMPLETED | 85 mg Sumatriptan/500 mg Naproxen Sodium | 363 | |
| Overall Study | NOT COMPLETED | 85 mg Sumatriptan/500 mg Naproxen Sodium | 293 |
Source ClinicalTrials.gov
Adverse events54
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 | Safety Population | 55 | 622 | |
| other | Nausea | Gastrointestinal disorders | 6 Month Completer Population | 28 | 333 | |
| other | Nausea | Gastrointestinal disorders | 12 Month Completer Population | 16 | 181 | |
| other | Upper respiratory tract infection | Infections and infestations | Safety Population | 54 | 622 | |
| other | Upper respiratory tract infection | Infections and infestations | 6 Month Completer Population | 39 | 333 | |
| other | Upper respiratory tract infection | Infections and infestations | 12 Month Completer Population | 22 | 181 | |
| other | Nasopharyngitis | Infections and infestations | Safety Population | 48 | 622 | |
| other | Nasopharyngitis | Infections and infestations | 6 Month Completer Population | 35 | 333 | |
| other | Nasopharyngitis | Infections and infestations | 12 Month Completer Population | 20 | 181 | |
| other | Sinusitis | Infections and infestations | Safety Population | 37 | 622 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Safety Population | ||
| Total, all-cause mortality | 6 Month Completer Population | ||
| Total, all-cause mortality | 12 Month Completer Population | ||
| Total, other adverse events | Safety Population | 257 | 622 |
| Total, other adverse events | 6 Month Completer Population | 159 | 333 |
| Total, other adverse events | 12 Month Completer Population | 89 | 181 |
| Total, serious adverse events | Safety Population | 4 | 622 |
| Total, serious adverse events | 6 Month Completer Population | 3 | 333 |
| Total, serious adverse events | 12 Month Completer Population | 1 | 181 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21797863 | BACKGROUND |
Source PubMed
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/NCT00488514
GET https://conductscience.org/api/trials/v1/NCT00488514/registered?page=2