Trial Outcomes & Findings for 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 NCT00383162)
NCT ID: NCT00383162
Last Updated: 2017-02-02
Results Overview
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.
COMPLETED
PHASE3
173 participants
2 - 24 hours post-dose
2017-02-02
Participant Flow
Participant milestones
| Measure |
Placebo/Sumatriptan-Naproxen
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).
|
Sumatriptan-Naproxen/Placebo
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).
|
|---|---|---|
|
Migraine Attack 1 (Period 1)
STARTED
|
87
|
86
|
|
Migraine Attack 1 (Period 1)
COMPLETED
|
67
|
73
|
|
Migraine Attack 1 (Period 1)
NOT COMPLETED
|
20
|
13
|
|
Migraine Attack 2 (Period 2)
STARTED
|
67
|
73
|
|
Migraine Attack 2 (Period 2)
COMPLETED
|
65
|
66
|
|
Migraine Attack 2 (Period 2)
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
| Measure |
Placebo/Sumatriptan-Naproxen
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).
|
Sumatriptan-Naproxen/Placebo
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).
|
|---|---|---|
|
Migraine Attack 1 (Period 1)
No opportunity to treat migraine
|
3
|
4
|
|
Migraine Attack 1 (Period 1)
Lost to Follow-up
|
8
|
7
|
|
Migraine Attack 1 (Period 1)
Did not meet eligibility criteria
|
4
|
2
|
|
Migraine Attack 1 (Period 1)
Withdrawal by Subject
|
2
|
0
|
|
Migraine Attack 1 (Period 1)
Non-compliant
|
3
|
0
|
|
Migraine Attack 2 (Period 2)
No opportunity to treat migraine 2
|
1
|
3
|
|
Migraine Attack 2 (Period 2)
Lost to Follow-up
|
0
|
1
|
|
Migraine Attack 2 (Period 2)
Adverse Event
|
1
|
0
|
|
Migraine Attack 2 (Period 2)
Unknown reason
|
0
|
3
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Safety Population
n=144 Participants
Safety Population - Participants who were randomized and who treated at least 1 migraine attack with investigational product.
|
|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 10.34 • n=5 Participants
|
|
Gender
Female
|
122 Participants
n=5 Participants
|
|
Gender
Male
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian/European heritage
|
132 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian Heritage
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South East Asian Heritage
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Arabic/North African Heritage
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other - Missing
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 - 24 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose
|
10 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 2 hours post-dosePopulation: 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 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.
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Pain-Free Assessment at 2 Hours Post-dose
|
23 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: Dosing to 24 hours post-dosePopulation: 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.
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).
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Rescue Medication Used up to 24 Hours Post-dose
|
84 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 1/2, 1, 4, and 8 hours post-dosePopulation: 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 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.
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose
1/2 hour post-dose
|
2 Participants
|
6 Participants
|
|
Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose
1 hour post-dose
|
13 Participants
|
26 Participants
|
|
Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose
4 hours post-dose
|
30 Participants
|
80 Participants
|
|
Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose
8 hours post-dose
|
32 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: 2 - 24 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Sustained Freedom From Migraine
|
11 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 2, 4 , and 8 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose
2 hours post-dose
|
19 Participants
|
47 Participants
|
|
Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose
4 hours post-dose
|
30 Participants
|
72 Participants
|
|
Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose
8 hours post-dose
|
29 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: 2 - 24 hours post-dosePopulation: 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.
Sustained Freedom from Migraine-Associated Sinus Pain was defined as the absence of sinus pain from 2 to 24 hours post-dose.
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Sustained Freedom From Migraine-Associated Sinus Pain
|
34 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, and 8 hours post-dosePopulation: 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.
Number of participants who had sinus pain at the time of assessment.
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Baseline
|
58 Participants
|
61 Participants
|
|
Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
2 hours post-dose
|
52 Participants
|
31 Participants
|
|
Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
4 hours post-dose
|
39 Participants
|
20 Participants
|
|
Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
8 hours post-dose
|
35 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 2 - 24 hours post-dosePopulation: 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.
Sustained Freedom from Migraine-Associated Neck Pain was defined as the absence of neck pain from 2 to 24 hours post-dose.
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Sustained Freedom From Migraine-Associated Neck Pain
|
33 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, and 8 hours post-dosePopulation: 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.
Number of Participants with neck pain at the time of assessment.
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Baseline
|
65 Participants
|
82 Participants
|
|
Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
2 hours post-dose
|
54 Participants
|
54 Participants
|
|
Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
4 hours post-dose
|
46 Participants
|
40 Participants
|
|
Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
8 hours post-dose
|
37 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 2 - 24 hours post-dosePopulation: 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.
Sustained Freedom from Migraine-Associated Photophobia was defined as the absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose.
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Sustained Freedom From Migraine-Associated Photophobia
|
23 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, and 8 hours post-dosePopulation: 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.
Number of participants who had photophobia (sensitivity to light) at the time of assessment.
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Baseline
|
98 Participants
|
95 Participants
|
|
Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
2 hours post-dose
|
86 Participants
|
57 Participants
|
|
Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
4 hours post-dose
|
65 Participants
|
33 Participants
|
|
Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
8 hours post-dose
|
48 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 2 - 24 hours post-dosePopulation: 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.
Sustained Freedom from Migraine-Associated Phonophobia was defined as the absence of phonophobia (sensitivity to noise) from 2 to 24 hours post-dose.
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Sustained Freedom From Migraine-Associated Phonophobia
|
31 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, and 8 hours post-dosePopulation: 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.
Number of participants who had phonophobia (sensitivity to noise) at the time of assessment.
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Baseline
|
82 Participants
|
86 Participants
|
|
Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
2 hours post-dose
|
73 Participants
|
47 Participants
|
|
Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
4 hours post-dose
|
56 Participants
|
31 Participants
|
|
Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
8 hours post-dose
|
44 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 2 - 24 hours post-dosePopulation: 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.
Sustained Freedom from Migraine-Associated Nausea was defined as the absence of nausea from 2 to 24 hours post-dose.
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Sustained Freedom From Migraine-Associated Nausea
|
38 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, and 8 hoursPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Baseline
|
45 Participants
|
48 Participants
|
|
Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose
2 hours post-dose
|
42 Participants
|
39 Participants
|
|
Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose
4 hours post-dose
|
29 Participants
|
20 Participants
|
|
Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose
8 hours post-dose
|
24 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 2 - 24 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Sustained Complete Pain/Symptom-Free
|
9 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, and 8 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=133 Participants
|
Sumatriptan-Naproxen Sodium
n=136 Participants
|
|---|---|---|
|
Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Baseline
|
133 Participants
|
136 Participants
|
|
Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose
2 hours post-dose
|
117 Participants
|
92 Participants
|
|
Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose
4 hours post-dose
|
107 Participants
|
73 Participants
|
|
Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose
8 hours post-dose
|
106 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: 24 hours and 48 hoursPopulation: 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
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.
Outcome measures
| Measure |
Placebo
n=23 Participants
|
Sumatriptan-Naproxen Sodium
n=54 Participants
|
|---|---|---|
|
Recurrence of Any Migraine Headache Pain
Recurrence by 48 hours post-dose
|
13 Participants
|
11 Participants
|
|
Recurrence of Any Migraine Headache Pain
Recurrence by 24 hours post-dose
|
12 Participants
|
11 Participants
|
Adverse Events
Placebo
Sumatriptan-Naproxen Sodium
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER