Trial · NCT00383162
A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 1 of 2)
NCT00383162, Phase 3, Completed, GlaxoSmithKline; results first posted 2010-02-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 1 of 2). Trials, record NCT00383162. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00383162
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 1 of 2)
- NCT number
- NCT00383162
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 173 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Migraine Disorders
- Interventions
- Combination Product (sumatriptan succinate / naproxen sodium), Placebo
- First posted
- 2006-10-02
- Last updated
- 2017-02-02
- Results first posted
- 2010-02-17
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose | 2 - 24 hours post-dose | Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose. |
| Secondary | Pain-Free Assessment at 2 Hours Post-dose | 2 hours post-dose | Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time. |
| Secondary | Rescue Medication Used up to 24 Hours Post-dose | Dosing to 24 hours post-dose | A rescue medication was defined as an additional medication taken for the treatment of migraine headache pain symptoms associated with the attack. Allowed were a single dose of either: sumatriptan (50mg or 100mg), OR naproxen sodium (max 550mg), OR, an over-the-counter pain-reliever (per label). |
| Secondary | Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose | 1/2, 1, 4, and 8 hours post-dose | Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time. |
| Secondary | Sustained Freedom From Migraine | 2 - 24 hours post-dose | Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea). Sustained migraine-free was defined as migraine-free at 2 hours and sustained from 2 to 24 hours post dose without the use of rescue medication. |
| Secondary | Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose | 2, 4 , and 8 hours post-dose | Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea and vomiting) at the time of the assessment. |
| Secondary | Sustained Freedom From Migraine-Associated Sinus Pain | 2 - 24 hours post-dose | Sustained Freedom from Migraine-Associated Sinus Pain was defined as the absence of sinus pain from 2 to 24 hours post-dose. |
| Secondary | Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose | Baseline, 2, 4, and 8 hours post-dose | Number of participants who had sinus pain at the time of assessment. |
| Secondary | Sustained Freedom From Migraine-Associated Neck Pain | 2 - 24 hours post-dose | Sustained Freedom from Migraine-Associated Neck Pain was defined as the absence of neck pain from 2 to 24 hours post-dose. |
| Secondary | Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose | Baseline, 2, 4, and 8 hours post-dose | Number of Participants with neck pain at the time of assessment. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose | 2 - 24 hours post-dose | Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack. | Participants | NUMBER |
| SECONDARY | Pain-Free Assessment at 2 Hours Post-dose | 2 hours post-dose | Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack. | Participants | NUMBER |
| SECONDARY | Rescue Medication Used up to 24 Hours Post-dose | Dosing to 24 hours post-dose | Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack. | Participants | NUMBER |
| SECONDARY | Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose | 1/2, 1, 4, and 8 hours post-dose | Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack. | Participants | NUMBER |
| SECONDARY | Sustained Freedom From Migraine | 2 - 24 hours post-dose | Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack. | Participants | NUMBER |
| SECONDARY | Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose | 2, 4 , and 8 hours post-dose | Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack. | Participants | NUMBER |
| SECONDARY | Sustained Freedom From Migraine-Associated Sinus Pain | 2 - 24 hours post-dose | Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack. | Participants | NUMBER |
| SECONDARY | Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose | Baseline, 2, 4, and 8 hours post-dose | Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack. | Participants | NUMBER |
| SECONDARY | Sustained Freedom From Migraine-Associated Neck Pain | 2 - 24 hours post-dose | Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack. | Participants | NUMBER |
| SECONDARY | Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose | Baseline, 2, 4, and 8 hours post-dose | Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack. | Participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose | Placebo | 10 | Participants | ||
| Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose | Sumatriptan-Naproxen Sodium | 36 | Participants | ||
| Pain-Free Assessment at 2 Hours Post-dose | Placebo | 23 | Participants | ||
| Pain-Free Assessment at 2 Hours Post-dose | Sumatriptan-Naproxen Sodium | 54 | Participants | ||
| Rescue Medication Used up to 24 Hours Post-dose | Placebo | 84 | Participants | ||
| Rescue Medication Used up to 24 Hours Post-dose | Sumatriptan-Naproxen Sodium | 40 | Participants | ||
| Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose | Placebo | 1/2 hour post-dose | 2 | Participants | |
| Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose | Sumatriptan-Naproxen Sodium | 1/2 hour post-dose | 6 | Participants | |
| Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose | Placebo | 1 hour post-dose | 13 | Participants | |
| Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose | Sumatriptan-Naproxen Sodium | 1 hour post-dose | 26 | Participants |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Migraine Attack 1 (Period 1) | STARTED | Placebo/Sumatriptan-Naproxen | 87 | |
| Migraine Attack 1 (Period 1) | STARTED | Sumatriptan-Naproxen/Placebo | 86 | |
| Migraine Attack 1 (Period 1) | COMPLETED | Placebo/Sumatriptan-Naproxen | 67 | |
| Migraine Attack 1 (Period 1) | COMPLETED | Sumatriptan-Naproxen/Placebo | 73 | |
| Migraine Attack 1 (Period 1) | NOT COMPLETED | Placebo/Sumatriptan-Naproxen | 20 | |
| Migraine Attack 1 (Period 1) | NOT COMPLETED | Sumatriptan-Naproxen/Placebo | 13 | |
| Migraine Attack 2 (Period 2) | STARTED | Placebo/Sumatriptan-Naproxen | 67 | |
| Migraine Attack 2 (Period 2) | STARTED | Sumatriptan-Naproxen/Placebo | 73 | |
| Migraine Attack 2 (Period 2) | COMPLETED | Placebo/Sumatriptan-Naproxen | 65 | |
| Migraine Attack 2 (Period 2) | COMPLETED | Sumatriptan-Naproxen/Placebo | 66 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse 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 Sodium | ||
| Total, other adverse events | Placebo | 0 | 135 |
| Total, other adverse events | Sumatriptan-Naproxen Sodium | 0 | 140 |
| Total, serious adverse events | Placebo | 0 | 135 |
| Total, serious adverse events | Sumatriptan-Naproxen Sodium | 0 | 140 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19486178 | 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 comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sumatriptan-Naproxen Sodium vs Placebo: Sustained Freedom From Migraine-Associated Nausea | Trial comparisons |
| Sumatriptan-Naproxen Sodium vs Placebo: Sustained Freedom From Migraine-Associated Sinus Pain | Trial comparisons |
| Sumatriptan-Naproxen Sodium vs Placebo: Sustained Freedom From Migraine-Associated Photophobia | Trial comparisons |
| Sumatriptan-Naproxen Sodium vs Placebo: Pain-Free Assessment at 2 Hours Post-dose | Trial comparisons |
| Sumatriptan-Naproxen Sodium vs Placebo: Sustained Freedom From Migraine-Associated Neck Pain | Trial comparisons |
| Sumatriptan-Naproxen Sodium vs Placebo: Sustained Complete Pain/Symptom-Free | Trial comparisons |
| Sumatriptan-Naproxen Sodium vs Placebo: Rescue Medication Used up to 24 Hours Post-dose | Trial comparisons |
| Sumatriptan-Naproxen Sodium vs Placebo: Sustained Freedom From Migraine-Associated Phonophobia | Trial comparisons |
| Sumatriptan-Naproxen Sodium vs Placebo: Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose | Trial comparisons |
| Sumatriptan-Naproxen Sodium vs Placebo: Sustained Freedom From Migraine | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
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/NCT00383162
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