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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 2 of 2)

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ClinicalTrials.gov Identifier: NCT00382993
Recruitment Status : Completed
First Posted : October 2, 2006
Results First Posted : April 20, 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: Placebo
Drug: Combination Product (sumatriptan succinate/naproxen sodium)
Enrollment 169
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 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
[1]
Participant considered to have completed period if treated a migraine with investigational product.
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
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 139
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 139 participants
40.1  (11.11)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants
Female
129
  92.8%
Male
10
   7.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 139 participants
White/Caucasian/European American 123
African American 10
Other 6
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
ITT (Intent-to-Treat) Population - included subjects in the Safety Population who provided an evaluation of their study drug 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 132 134
Measure Type: Number
Unit of Measure: Participants
10 41
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 ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.63
Confidence Interval 95%
2.76 to 11.49
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Migraine Headache Pain Free 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
ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug 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 132 134
Measure Type: Number
Unit of Measure: Participants
19 59
3.Secondary Outcome
Title Rescue Medication Use During 0 - 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 0-24 Hours Post-Dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug 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 132 134
Measure Type: Number
Unit of Measure: Participants
72 29
4.Secondary Outcome
Title Migraine Headache Pain Free at 0.5, 1, 4, and 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 0.5, 1, 4, and 8 Hours Post-Dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug 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 132 134
Measure Type: Number
Unit of Measure: Participants
Pain Free at 0.5 Hour Post-Dose 3 3
Pain Free at 1 Hour Post-Dose 12 33
Pain Free at 4 Hours Post-Dose 23 83
Pain Free at 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
[Not Specified]
Arm/Group Title Placebo Sumatriptan/Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 132 134
Measure Type: Number
Unit of Measure: Participants
8 34
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
ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug 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 132 134
Measure Type: Number
Unit of Measure: Participants
Migraine-Free at 2 Hours Post-Dose 15 46
Migraine-Free at 4 Hours Post-Dose 20 76
Migraine-Free at 8 Hours Post-Dose 30 83
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
[Not Specified]
Arm/Group Title Placebo Sumatriptan/Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 132 134
Measure Type: Number
Unit of Measure: Participants
44 75
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
ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug 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 132 134
Measure Type: Number
Unit of Measure: Participants
Migraine-Assoc Sinus Pain at Baseline 47 56
Migraine-Assoc Sinus Pain at 2 Hours Post-Dose 40 41
Migraine-Assoc Sinus Pain at 4 Hours Post-Dose 36 27
Migraine-Assoc Sinus Pain at 8 Hours Post-Dose 27 20
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
[Not Specified]
Arm/Group Title Placebo Sumatriptan/Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 132 134
Measure Type: Number
Unit of Measure: Participants
29 65
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
ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug 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 132 134
Measure Type: Number
Unit of Measure: Participants
Migraine-Assoc Neck Pain at Baseline 81 75
Migraine-Assoc Neck Pain at 2 Hours Post-Dose 71 52
Migraine-Assoc Neck Pain at 4 Hours Post-Dose 65 38
Migraine-Assoc Neck Pain at 8 Hours Post-Dose 51 29
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
[Not Specified]
Arm/Group Title Placebo Sumatriptan/Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 132 134
Measure Type: Number
Unit of Measure: Participants
23 65
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
ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug 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 132 134
Measure Type: Number
Unit of Measure: Participants
Migraine Assoc Photophobia-Baseline 100 101
Migraine Assoc Photophobia 2 Hours Post-Dose 84 48
Migraine Assoc Photophobia 4 Hours Post-Dose 69 31
Migraine Assoc Photophobia 8 Hours Post-Dose 51 25
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
[Not Specified]
Arm/Group Title Placebo Sumatriptan/Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 132 134
Measure Type: Number
Unit of Measure: Participants
30 68
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
ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug 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 132 134
Measure Type: Number
Unit of Measure: Participants
Migraine Assoc Phonophobia-Baseline 75 80
Migraine Assoc Phonophobia 2 Hours Post-Dose 68 42
Migraine Assoc Phonophobia 4 Hours Post-Dose 56 27
Migraine Assoc Phonophobia 8 Hours Post-Dose 42 20
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
[Not Specified]
Arm/Group Title Placebo Sumatriptan/Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 132 134
Measure Type: Number
Unit of Measure: Participants
38 79
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
ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug 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 132 134
Measure Type: Number
Unit of Measure: Participants
Migraine Associated Nausea at Baseline 40 48
Migraine Associated Nausea 2 Hours Post-Dose 43 33
Migraine Associated Nausea 4 Hours Post-Dose 35 18
Migraine Associated Nausea 8 Hours Post-Dose 27 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
[Not Specified]
Arm/Group Title Placebo Sumatriptan/Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 132 134
Measure Type: Number
Unit of Measure: Participants
7 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
ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug 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 132 134
Measure Type: Number
Unit of Measure: Participants
Complete Pain/Symptom-Baseline 132 134
Complete Pain/Symptom-2 Hours Post-Dose 121 94
Complete Pain/Symptom-4 Hours Post-Dose 114 70
Complete Pain/Symptom-8 Hours Post-Dose 106 58
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.
Arm/Group Title Placebo Sumatriptan/Naproxen Sodium
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 19 59
Measure Type: Number
Unit of Measure: Participants
Recurrence by 24 hours post-dose 5 13
Recurrence by 48 hours post-dose 6 13
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
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).
All-Cause Mortality
Placebo/Sumatriptan-Naproxen Sumatriptan-Naproxen/Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo/Sumatriptan-Naproxen Sumatriptan-Naproxen/Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/135 (0.00%)   0/134 (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 Sumatriptan-Naproxen/Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/135 (0.00%)   0/134 (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 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     History of Changes
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