A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 2 of 2)
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| ClinicalTrials.gov Identifier: NCT00382993 |
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Recruitment Status :
Completed
First Posted : October 2, 2006
Results First Posted : April 20, 2010
Last Update Posted : February 2, 2017
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Migraine Disorders |
| Interventions |
Drug: Placebo Drug: Combination Product (sumatriptan succinate/naproxen sodium) |
| Enrollment | 169 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Placebo/Sumatriptan-Naproxen | Sumatriptan-Naproxen/Placebo |
|---|---|---|
 Arm/Group Description |
Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2). | Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2). |
| Period Title: Migraine Attack 1 (Period 1) | ||
| Started | 84 | 85 |
| Completed | 70 [1] | 67 |
| Not Completed | 14 | 18 |
| Reason Not Completed | ||
| Lost to Follow-up | 7 | 2 |
| Withdrawal by Subject | 1 | 3 |
| Lack of opportunity to treat migraine | 0 | 5 |
| Did not meet Eligibility Criteria | 3 | 3 |
| Other (no additional data present) | 3 | 5 |
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[1]
Participant considered to have completed period if treated a migraine with investigational product.
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| Period Title: Migraine Attack 2 (Period 2) | ||
| Started | 70 | 67 |
| Completed | 68 | 63 |
| Not Completed | 2 | 4 |
| Reason Not Completed | ||
| Lost to Follow-up | 1 | 0 |
| Lack of opportunity to treat migraine | 0 | 1 |
| Did not meet Eligibility Criteria | 0 | 1 |
| Protocol Violation | 0 | 1 |
| Other (no additional data present) | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Safety Population | |
|---|---|---|
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Arm/Group Description |
Safety Population - Participants who were randomized and who treated at least 1 migraine attack with investigational product. | |
| Overall Number of Baseline Participants | 139 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 139 participants | |
| 40.1 (11.11) | ||
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Gender
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 139 participants | |
| Female |
129 92.8%
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| Male |
10 7.2%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 139 participants |
| White/Caucasian/European American | 123 | |
| African American | 10 | |
| Other | 6 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centres of a multi-centre trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title: | GSK Response Center |
| Organization: | Glaxo Smith Kline |
| Phone: | 1-866-435-7343 |
Publications:
Mathew N, Landy S, Tietjen G, Stark S, Runken M, Lener S, Derosier F, and Bukenya D. Evaluation of a single fixed-dose tablet of Sumatriptan 85 mg formulated with RT Technology/Naproxen sodium 500 mg (SumaRT/Nap) in Subjects who Reported Poor Response or Intolerance to Short Acting Triptans for the Acute Treatment of Migraine. Headache 2008: S44-45.
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00382993 |
| Other Study ID Numbers: |
TRX106573 |
| First Submitted: | September 29, 2006 |
| First Posted: | October 2, 2006 |
| Results First Submitted: | November 14, 2008 |
| Results First Posted: | April 20, 2010 |
| Last Update Posted: | February 2, 2017 |