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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)

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ClinicalTrials.gov Identifier: NCT00383162
Recruitment Status : Completed
First Posted : October 2, 2006
Results First Posted : February 17, 2010
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine Disorders
Interventions Drug: Combination Product (sumatriptan succinate / naproxen sodium)
Drug: Placebo
Enrollment 173
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo/Sumatriptan-Naproxen Sumatriptan-Naproxen/Placebo
Hide 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 87 86
Completed 67 [1] 73 [2]
Not Completed 20 13
Reason Not Completed
No opportunity to treat migraine             3             4
Lost to Follow-up             8             7
Did not meet eligibility criteria             4             2
Withdrawal by Subject             2             0
Non-compliant             3             0
[1]
Participants completing a period treated a migraine with investigational product.
[2]
Participants not completing did not take investigational product.
Period Title: Migraine Attack 2 (Period 2)
Started 67 73
Completed 65 66
Not Completed 2 7
Reason Not Completed
No opportunity to treat migraine 2             1             3
Lost to Follow-up             0             1
Adverse Event             1             0
Unknown reason             0             3
Arm/Group Title Safety Population
Hide 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 144
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 144 participants
41.1  (10.34)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 144 participants
Female
122
  84.7%
Male
22
  15.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 144 participants
White/Caucasian/European heritage 132
African American/African Heritage 5
East Asian Heritage 1
South East Asian Heritage 2
Arabic/North African Heritage 1
Mixed Race 1
Other - Missing 2
1.Primary Outcome
Title Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose
Hide Description 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.
Time Frame 2 - 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
10 36
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sumatriptan-Naproxen Sodium
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Generalized Estimating Equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.50
Confidence Interval 95%
2.17 to 9.36
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Pain-Free Assessment at 2 Hours Post-dose
Hide Description 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.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
23 54
3.Secondary Outcome
Title Rescue Medication Used up to 24 Hours Post-dose
Hide Description 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).
Time Frame Dosing to 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
84 40
4.Secondary Outcome
Title Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose
Hide Description 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.
Time Frame 1/2, 1, 4, and 8 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
1/2 hour post-dose 2 6
1 hour post-dose 13 26
4 hours post-dose 30 80
8 hours post-dose 32 88
5.Secondary Outcome
Title Sustained Freedom From Migraine
Hide Description 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.
Time Frame 2 - 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
11 32
6.Secondary Outcome
Title Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose
Hide Description 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.
Time Frame 2, 4 , and 8 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
2 hours post-dose 19 47
4 hours post-dose 30 72
8 hours post-dose 29 80
7.Secondary Outcome
Title Sustained Freedom From Migraine-Associated Sinus Pain
Hide Description Sustained Freedom from Migraine-Associated Sinus Pain was defined as the absence of sinus pain from 2 to 24 hours post-dose.
Time Frame 2 - 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
34 76
8.Secondary Outcome
Title Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Hide Description Number of participants who had sinus pain at the time of assessment.
Time Frame Baseline, 2, 4, and 8 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
Baseline 58 61
2 hours post-dose 52 31
4 hours post-dose 39 20
8 hours post-dose 35 19
9.Secondary Outcome
Title Sustained Freedom From Migraine-Associated Neck Pain
Hide Description Sustained Freedom from Migraine-Associated Neck Pain was defined as the absence of neck pain from 2 to 24 hours post-dose.
Time Frame 2 - 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
33 63
10.Secondary Outcome
Title Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Hide Description Number of Participants with neck pain at the time of assessment.
Time Frame Baseline, 2, 4, and 8 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
Baseline 65 82
2 hours post-dose 54 54
4 hours post-dose 46 40
8 hours post-dose 37 31
11.Secondary Outcome
Title Sustained Freedom From Migraine-Associated Photophobia
Hide Description Sustained Freedom from Migraine-Associated Photophobia was defined as the absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose.
Time Frame 2 - 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
23 59
12.Secondary Outcome
Title Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Hide Description Number of participants who had photophobia (sensitivity to light) at the time of assessment.
Time Frame Baseline, 2, 4, and 8 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
Baseline 98 95
2 hours post-dose 86 57
4 hours post-dose 65 33
8 hours post-dose 48 27
13.Secondary Outcome
Title Sustained Freedom From Migraine-Associated Phonophobia
Hide Description Sustained Freedom from Migraine-Associated Phonophobia was defined as the absence of phonophobia (sensitivity to noise) from 2 to 24 hours post-dose.
Time Frame 2 - 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
31 66
14.Secondary Outcome
Title Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Hide Description Number of participants who had phonophobia (sensitivity to noise) at the time of assessment.
Time Frame Baseline, 2, 4, and 8 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
Baseline 82 86
2 hours post-dose 73 47
4 hours post-dose 56 31
8 hours post-dose 44 24
15.Secondary Outcome
Title Sustained Freedom From Migraine-Associated Nausea
Hide Description Sustained Freedom from Migraine-Associated Nausea was defined as the absence of nausea from 2 to 24 hours post-dose.
Time Frame 2 - 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
38 70
16.Secondary Outcome
Title Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Hide Description Number of participants who had nausea at the time of assessment. Resolution of an associated symptom was defined as a migraine headache symptom that was present at the time of treatment that was not present post-dose. Symptom resolution was defined only among subjects who treated while their symptom was present.
Time Frame Baseline, 2, 4, and 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
Baseline 45 48
2 hours post-dose 42 39
4 hours post-dose 29 20
8 hours post-dose 24 14
17.Secondary Outcome
Title Sustained Complete Pain/Symptom-Free
Hide Description Sustained Complete Pain/Symptom-Free was defined as completely symptom-free (migraine-free plus neck and sinus pain-free) at 2 hours and sustained from 2 to 24 hours without the use of rescue medication.
Time Frame 2 - 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
9 30
18.Secondary Outcome
Title Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Hide Description Number of participants who were completely symptom-free (migraine-free plus neck and sinus pain-free) at time of assessment.“Complete pain/symptom-free” was defined as migraine-free, neck pain-free, and sinus pain free.
Time Frame Baseline, 2, 4, and 8 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 133 136
Measure Type: Number
Unit of Measure: Participants
Baseline 133 136
2 hours post-dose 117 92
4 hours post-dose 107 73
8 hours post-dose 106 62
19.Secondary Outcome
Title Recurrence of Any Migraine Headache Pain
Hide Description Recurrence is defined as the return of any migraine headache pain during the specified post-dose period, following a pain-free response at 2 hours.
Time Frame 24 hours and 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Subpopulation of the Intent-to-Treat population of subjects who were pain-free at 2 hours post-dose. Placebo-23 subjects and Sumatriptan/Naproxen Sodium 54 subjects
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 23 54
Measure Type: Number
Unit of Measure: Participants
Recurrence by 24 hours post-dose 12 11
Recurrence by 48 hours post-dose 13 11
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Sumatriptan-Naproxen Sodium
Hide Arm/Group Description Subjects who were randomized to take Placebo during Migraine period 1, then a one week wash-out period without any drugs, and then given Sumatriptan 85 mg/Naproxen Sodium 500 mg during Migraine period 2. Subjects who were randomized to take Sumatriptan 85 mg/Naproxen Sodium 500 mg during Migraine period 1, then a one week wash-out period without any drugs, and then given Placebo during Migraine period 2.
All-Cause Mortality
Placebo Sumatriptan-Naproxen Sodium
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Sumatriptan-Naproxen Sodium
Affected / at Risk (%) Affected / at Risk (%)
Total   0/135 (0.00%)   0/140 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Sumatriptan-Naproxen Sodium
Affected / at Risk (%) Affected / at Risk (%)
Total   0/135 (0.00%)   0/140 (0.00%) 
Certain Agreements
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 centers of a multi-center 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: GlaxoSmithKline
Phone: 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: NCT00383162     History of Changes
Other Study ID Numbers: TRX106571
First Submitted: September 29, 2006
First Posted: October 2, 2006
Results First Submitted: October 3, 2008
Results First Posted: February 17, 2010
Last Update Posted: February 2, 2017