Trial · NCT00843024
Migraine Study in Adolescent Patients
NCT00843024, Phase 3, Completed, GlaxoSmithKline; results first posted 2011-05-09
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ConductScience Library. Migraine Study in Adolescent Patients. Trials, record NCT00843024. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00843024
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Migraine Study in Adolescent Patients
- NCT number
- NCT00843024
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 589 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Migraine Disorders
- Interventions
- Sumatriptan and Naproxen Sodium, Placebo
- First posted
- 2009-02-13
- Last updated
- 2017-01-18
- Results first posted
- 2011-05-09
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Were Pain Free at 2 Hours Post-dose | 2 hours after single dose of double-blind treatment (Randomization through Week 13) | Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. Participants with pain-free response were considered as those who had a reduction in migraine headache pain from moderate (score=2) or severe (score=3) at baseline to none (score=0) post-treatment, without the use of rescue medication (additional medication taken by participants for the treatment of migraine pain or associated symptoms) prior to or at 2 hours post-dose. |
| Secondary | Number of Participants Sustained Pain-free From 2-24 Hours | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | Participants with sustained pain-freedom were defined as those with pain-freedom at 2 hours post-dose that was maintained up to 24 hours post-treatment without the use of rescue medication. |
| Secondary | Number of Participants Photophobia-free at 2 Hours Post-dose | 2 hours after single dose of double-blind treatment (Randomization through Week 13) | The number of participants who did not have photophobia (sensitivity to light) at 2 hours post dose was analyzed. |
| Secondary | Number of Participants Phonophobia-free at 2 Hours Post-dose | 2 hours after single dose of double-blind treatment (Randomization through Week 13) | The number of participants who did not have phonophobia (sensitivity to sound) at 2 hours post dose was analzyed. |
| Secondary | Number of Participants Pain-free at 1 Hour Post-dose | 1 hour after single dose of double-blind treatment (Randomization through Week 13) | Participants with a pain-free response at 1 hour post-dose were considered as those who had a reduction in migraine headache pain from moderate (a score of 2) or severe (a score of 3) at baseline to none (a score of 0) post-treatment, without the use of rescue medication prior to or at 1 hour post dose. |
| Secondary | Number of Participants Sustained Photophobia-free From 2-24 Hours | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | Participants with sustained freedom from photophobia were those with an absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose without the use of rescue medication. |
| Secondary | Number of Participants Sustained Phonophobia-free From 2-24 Hours | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | Participants with sustained freedom from phonophobia were those with an absence of phonophobia (sensitivity to sound) from 2 to 24 hours post-dose without the use of rescue medication. |
| Secondary | Number of Participants Sustained Nausea-free From 2-24 Hours | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | Participants with sustained freedom from nausea were those with an absence of nausea from 2 to 24 hours post-dose without the use of rescue medication. |
| Secondary | Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with investigational product. Permitted rescue medications included oral naproxen sodium (maximum 15 mg/kg), oral over-the-counter pain reliever, and anti-emetics. This outcome measure included only participants who rescued from 2 to 24 hours post-dose, inclusive. |
| Secondary | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with double-blind treatment. In addition to participants who rescued from 2 to 24 hours post-dose, inclusive, this outcome measure also included nine protocol violators who rescued \< 2 hours post-treatment. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Were Pain Free at 2 Hours Post-dose | 2 hours after single dose of double-blind treatment (Randomization through Week 13) | ITT Population: participants who took a dose of double-blind randomized treatment and provided some assessment of their migraine pain or associated symptoms. Participants were not included in this analysis if their baseline pain was not moderate or severe, or if they had no post-baseline evaluation of pain up to the time point analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants Sustained Pain-free From 2-24 Hours | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants Photophobia-free at 2 Hours Post-dose | 2 hours after single dose of double-blind treatment (Randomization through Week 13) | ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants Phonophobia-free at 2 Hours Post-dose | 2 hours after single dose of double-blind treatment (Randomization through Week 13) | ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants Pain-free at 1 Hour Post-dose | 1 hour after single dose of double-blind treatment (Randomization through Week 13) | ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants Sustained Photophobia-free From 2-24 Hours | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants Sustained Phonophobia-free From 2-24 Hours | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants Sustained Nausea-free From 2-24 Hours | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed. | participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group256
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Were Pain Free at 2 Hours Post-dose | Placebo | Total Population, n=142, 96, 97, 150 | 14 | participants | |
| Number of Participants Who Were Pain Free at 2 Hours Post-dose | Sumatriptan 10 mg/ Naproxen 60 mg | Total Population, n=142, 96, 97, 150 | 28 | participants | |
| Number of Participants Who Were Pain Free at 2 Hours Post-dose | Sumatriptan 30 mg/ Naproxen 180 mg | Total Population, n=142, 96, 97, 150 | 26 | participants | |
| Number of Participants Who Were Pain Free at 2 Hours Post-dose | Sumatriptan 85 mg/ Naproxen 500 mg | Total Population, n=142, 96, 97, 150 | 36 | participants | |
| Number of Participants Who Were Pain Free at 2 Hours Post-dose | Placebo | 12-14 years, n=70, 43, 46, 65 | 10 | participants | |
| Number of Participants Who Were Pain Free at 2 Hours Post-dose | Sumatriptan 10 mg/ Naproxen 60 mg | 12-14 years, n=70, 43, 46, 65 | 18 | participants | |
| Number of Participants Who Were Pain Free at 2 Hours Post-dose | Sumatriptan 30 mg/ Naproxen 180 mg | 12-14 years, n=70, 43, 46, 65 | 13 | participants | |
| Number of Participants Who Were Pain Free at 2 Hours Post-dose | Sumatriptan 85 mg/ Naproxen 500 mg | 12-14 years, n=70, 43, 46, 65 | 17 | participants | |
| Number of Participants Who Were Pain Free at 2 Hours Post-dose | Placebo | 15-17 years, n=72, 53, 51, 85 | 4 | participants | |
| Number of Participants Who Were Pain Free at 2 Hours Post-dose | Sumatriptan 10 mg/ Naproxen 60 mg | 15-17 years, n=72, 53, 51, 85 | 10 | participants |
1 to 10 of 256Source ClinicalTrials.gov
See all 256 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Single-blind Placebo Run-In Phase | STARTED | 12 to 14 Years Age Group: Single-blind Phase | 408 | |
| Single-blind Placebo Run-In Phase | STARTED | 15 to 17 Years Age Group: Single-blind Phase | 457 | |
| Single-blind Placebo Run-In Phase | STARTED | Placebo | 0 | |
| Single-blind Placebo Run-In Phase | STARTED | Sumatriptan 10 mg/ Naproxen 60 mg | 0 | |
| Single-blind Placebo Run-In Phase | STARTED | Sumatriptan 30 mg/ Naproxen 180 mg | 0 | |
| Single-blind Placebo Run-In Phase | STARTED | Sumatriptan 85 mg/ Naproxen 500 mg | 0 | |
| Single-blind Placebo Run-In Phase | COMPLETED | 12 to 14 Years Age Group: Single-blind Phase | 268 | |
| Single-blind Placebo Run-In Phase | COMPLETED | 15 to 17 Years Age Group: Single-blind Phase | 321 | |
| Single-blind Placebo Run-In Phase | COMPLETED | Placebo | 0 | |
| Single-blind Placebo Run-In Phase | COMPLETED | Sumatriptan 10 mg/ Naproxen 60 mg | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events35
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 | Nasopharyngitis | Infections and infestations | Placebo | 3 | 145 | |
| other | Nasopharyngitis | Infections and infestations | Sumatriptan 10 mg/ Naproxen 60 mg | 0 | 96 | |
| other | Nasopharyngitis | Infections and infestations | Sumatriptan 30 mg/ Naproxen 180 mg | 1 | 97 | |
| other | Nasopharyngitis | Infections and infestations | Sumatriptan 85 mg/ Naproxen 500 mg | 1 | 152 | |
| other | Nasopharyngitis | Infections and infestations | Single-blind Run-In Phase Placebo | 10 | 683 | |
| other | Hot flush | Vascular disorders | Placebo | 0 | 145 | |
| other | Hot flush | Vascular disorders | Sumatriptan 10 mg/ Naproxen 60 mg | 0 | 96 | |
| other | Hot flush | Vascular disorders | Sumatriptan 30 mg/ Naproxen 180 mg | 2 | 97 | |
| other | Hot flush | Vascular disorders | Sumatriptan 85 mg/ Naproxen 500 mg | 1 | 152 | |
| other | Hot flush | Vascular disorders | Single-blind Run-In Phase Placebo | 1 | 683 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Sumatriptan 10 mg/ Naproxen 60 mg | ||
| Total, all-cause mortality | Sumatriptan 30 mg/ Naproxen 180 mg | ||
| Total, all-cause mortality | Sumatriptan 85 mg/ Naproxen 500 mg | ||
| Total, all-cause mortality | Single-blind Run-In Phase Placebo | ||
| Total, other adverse events | Placebo | 3 | 145 |
| Total, other adverse events | Sumatriptan 10 mg/ Naproxen 60 mg | 0 | 96 |
| Total, other adverse events | Sumatriptan 30 mg/ Naproxen 180 mg | 3 | 97 |
| Total, other adverse events | Sumatriptan 85 mg/ Naproxen 500 mg | 4 | 152 |
| Total, other adverse events | Single-blind Run-In Phase Placebo | 11 | 683 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
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/NCT00843024
GET https://conductscience.org/api/trials/v1/NCT00843024/results?page=2