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)

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00383162
• Collaborator: (none)
• Enrollment: 173
• Locations: 26
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 6.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design). [Study 1 of 2]

Condition or Disease	Intervention/Treatment	Phase
Migraine Disorders	Drug: Combination Product (sumatriptan succinate / naproxen sodium); Drug: Placebo	Phase 3

Detailed Description

This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design); however, the order of these treatments will be randomized. A minimum 1-week washout period is required between study medication treatment of the first and second migraine attacks.

Each subject will have two visits: (1) a Screening visit at study entry and (2) a Final visit 4-10 days after the second (or last) attack. A telephone contact will also be required 1-3 days after the first attack, and then once per month until the Final visit.

The primary study objective is to assess efficacy as measured by sustained pain-free (SPF) relief of Combination Product compared to placebo in treating migraine subjects who have previously discontinued treatment with short acting triptans (rizatriptan, sumatriptan, almotriptan, zolmitriptan, and eletriptan).

Study Design

• Study Type: Interventional
• Actual Enrollment: 173 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official 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)
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Other: Combination Product - Placebo Combination product (sumatriptan and naproxen sodium) [Attack 1] followed by placebo [Attack 2]	Drug: Combination Product (sumatriptan succinate / naproxen sodium); Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer, and 500mg naproxen sodium active ingredient in the second layer.; Drug: Placebo; Matching placebo tablet.
Other: Placebo - Combination Product Placebo [Attack 1] followed by Combination Product (sumatriptan and naproxen sodium) [Attack 2]	Drug: Combination Product (sumatriptan succinate / naproxen sodium); Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer, and 500mg naproxen sodium active ingredient in the second layer.; Drug: Placebo; Matching placebo tablet.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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).

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. Sustained Freedom From Migraine-Associated Photophobia [2 - 24 hours post-dose]

    Sustained Freedom from Migraine-Associated Photophobia was defined as the absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose.

11. Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose [Baseline, 2, 4, and 8 hours post-dose]

    Number of participants who had photophobia (sensitivity to light) at the time of assessment.

12. Sustained Freedom From Migraine-Associated Phonophobia [2 - 24 hours post-dose]

    Sustained Freedom from Migraine-Associated Phonophobia was defined as the absence of phonophobia (sensitivity to noise) from 2 to 24 hours post-dose.

13. Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose [Baseline, 2, 4, and 8 hours post-dose]

    Number of participants who had phonophobia (sensitivity to noise) at the time of assessment.

14. Sustained Freedom From Migraine-Associated Nausea [2 - 24 hours post-dose]

    Sustained Freedom from Migraine-Associated Nausea was defined as the absence of nausea from 2 to 24 hours post-dose.

15. Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose [Baseline, 2, 4, and 8 hours]

    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.

16. Sustained Complete Pain/Symptom-Free [2 - 24 hours post-dose]

    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.

17. Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose [Baseline, 2, 4, and 8 hours post-dose]

    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.

18. Recurrence of Any Migraine Headache Pain [24 hours and 48 hours]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject is male or female between 18 and 65 years old.

• Subject has migraine with or without aura (2004 ICHD-II criteria).

• Subject has 1-8 migraines per month over the previous 3 months and less than 15 total headache days per month.

• Subject has recently (within 1 year) discontinued the use of eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan, due to nonresponse or intolerable adverse events. Non-response is defined as documented discontinuation of treatment with eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan for reasons related to response, including (but not limited to): slow onset of efficacy, inconsistent efficacy, inadequate overall efficacy, or inadequate sustained efficacy through 24 hours. Intolerance is defined as documented discontinuation of treatment with eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan for other reasons, attributable to the triptan, outside of non-response.

A female is eligible to enter and participate in this study if she is of:

• non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,

• child-bearing potential, has a negative urine pregnancy test at screen, and agrees to one of the following acceptable measures of contraception:

• Complete abstinence from intercourse from 2 weeks prior to administration of the investigational product, throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 5 days); subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit; or,

• Female sterilization; or,

• Sterilization of male partner; or,

• Implants of levonorgestrel; or,

• Injectable progestogen; or,

• Oral contraceptive (combined or progestogen only); or,

• Any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or,

• Spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm); or,

• Any other methods with published data showing that the highest expected failure rate for that method is less than 1% per year; or,

• Any other barrier methods only if used in combination with any of the above acceptable methods.

• Subject taking oral contraceptives has been on a stable regimen for at least 2 months prior to screening.

• Subject is willing and able to provide informed consent prior to entry into this treatment phase of the study.

• Subject is able to understand and complete the diary card.

Exclusion Criteria: Subjects with any of the following criteria may not enroll in the study:

• Subject has non-migraine headache, retinal migraine, basilar or hemiplegic migraine, cluster headache, or headaches secondary to trauma, cranial or cervical disorders, infections, alterations of homeostasis, ENT disorders, psychiatric disorders or cranial neuralgias.

• Subject has confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal's angina/coronary vasospasm, or signs/symptoms consistent with any of the above.

• Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome.

• Subject has cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.

• Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks (TIAs).

• Subject has a history of congenital heart disease.

• Subject has uncontrolled hypertension at screening (sitting systolic pressure ≥140mmHg, diastolic pressure ≥90mmHg).

• Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (based on history or the presence of risk factors including but not limited to, hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of coronary artery disease, female with surgical or physiological menopause, or male over 40 years of age).

• Subject has a history of epilepsy or structural brain lesions which lower the convulsive threshold or treated with an antiepileptic drug for seizure control within 5 years prior to screening.

• Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.

• Subject is currently taking a monoamine oxidase inhibitor (MAOI), or has taken a MAOI within 2 weeks prior to screening or plans to take within 2 weeks after treatment.

• Subject is currently taking, or has taken in the previous three months, a migraine prophylactic medication containing methysergide or dihydroergotamine; or is taking a medication that is not stabilized (i.e. change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized..

• Subject is currently taking any anti-coagulant (e.g., warfarin).

• Subject has a recent history of regular use of opioids or barbiturates for treatment of their migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month over the last 6 months.

• Subject is currently taking or has taken in the previous 4 weeks, herbal preparations containing St. John's Wort (Hypericum perforatum).

• Subject has hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of their components or any other 5-HT1 receptor agonist.

• Subject has a history of allergic reactions to naproxen preparations, including subject in whom aspirin or other NSAID drugs induce the syndrome of asthma, rhinitis, and nasal polyps.

• Subject has a history of any gastrointestinal surgery that specifically indicates a past history of bleeding, ulceration or perforation.

• Subject has a history of gastric bypass or stapling surgery.

• Subject has a history of GI ulceration in the past six months or gastrointestinal bleeding in the past year.

• Subject has a history of inflammatory bowel disease.

• Subject has a history of any bleeding disorder.

• Subject is taking any antiplatelet agent (except low-dose aspirin ≤ 325mg/day for cardioprotective reasons).

• Subject is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.

• Subject is pregnant, actively trying to become pregnant or breast-feeding.

• Subject has evidence of alcohol or substance abuse within the last year which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results.

• Subject has any concurrent medical or psychiatric condition which, in the investigator's opinion, may affect the interpretation of efficacy and safety data or which otherwise contraindicates participation in this clinical trial.

• Subject has participated in an investigational drug trial within the previous four weeks or plans to participate in another study at any time during this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Fresno	California	United States	93720
2	GSK Investigational Site	Newport Beach	California	United States	92660
3	GSK Investigational Site	Santa Monica	California	United States	90404
4	GSK Investigational Site	Walnut Creek	California	United States	94596
5	GSK Investigational Site	Fairfield	Connecticut	United States	06824
6	GSK Investigational Site	Stamford	Connecticut	United States	06902
7	GSK Investigational Site	Aventura	Florida	United States	33180
8	GSK Investigational Site	Tallahassee	Florida	United States	32308
9	GSK Investigational Site	Tampa	Florida	United States	33609
10	GSK Investigational Site	Chicago	Illinois	United States	60614
11	GSK Investigational Site	Northbrook	Illinois	United States	60062
12	GSK Investigational Site	South Bend	Indiana	United States	46601
13	GSK Investigational Site	Lenexa	Kansas	United States	66214
14	GSK Investigational Site	St. Louis	Missouri	United States	63110
15	GSK Investigational Site	Omaha	Nebraska	United States	68144
16	GSK Investigational Site	Orchard Park	New York	United States	14127
17	GSK Investigational Site	Greensboro	North Carolina	United States	27401
18	GSK Investigational Site	Matthews	North Carolina	United States	28105
19	GSK Investigational Site	Raleigh	North Carolina	United States	27607
20	GSK Investigational Site	Tabor City	North Carolina	United States	28463
21	GSK Investigational Site	Fargo	North Dakota	United States	58103
22	GSK Investigational Site	Dallas	Texas	United States	75214
23	GSK Investigational Site	Houston	Texas	United States	77004
24	GSK Investigational Site	Alexandria	Virginia	United States	22304
25	GSK Investigational Site	Roanoke	Virginia	United States	24013
26	GSK Investigational Site	Virginia Beach	Virginia	United States	23452

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

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.
• Mathew NT, Landy S, Stark S, Tietjen GE, Derosier FJ, White J, Lener SE, Bukenya D. Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life. Headache. 2009 Jul;49(7):971-82. doi: 10.1111/j.1526-4610.2009.01458.x. Epub 2009 May 27.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00383162
• Other Study ID Numbers: TRX106571
• First Posted: Oct 2, 2006
• Last Update Posted: Feb 2, 2017
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Combination Product; naproxen sodium; sumatriptan succinate; short acting triptan; migraine, acute; Poor response
• Additional relevant MeSH terms: Migraine Disorders; Naproxen; Sumatriptan

Study Results

Participant Flow

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	87	86
COMPLETED	67	73
NOT COMPLETED	20	13
Period Title: Migraine Attack 1 (Period 1)
STARTED	67	73
COMPLETED	65	66
NOT COMPLETED	2	7

Baseline Characteristics

Arm/Group Title	Safety Population
Arm/Group Description	Safety Population - Participants who were randomized and who treated at least 1 migraine attack with investigational product.
Overall Participants	144
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.1 (10.34)
Gender (Count of Participants)
Female	122 84.7%
Male	22 15.3%
Race/Ethnicity, Customized (participants) [Number]
White/Caucasian/European heritage	132 91.7%
African American/African Heritage	5 3.5%
East Asian Heritage	1 0.7%
South East Asian Heritage	2 1.4%
Arabic/North African Heritage	1 0.7%
Mixed Race	1 0.7%
Other - Missing	2 1.4%

Outcome Measures

1. Primary Outcome

Title	Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
Number [Participants]	10 6.9%	36 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Sumatriptan-Naproxen Sodium
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Generalized Estimating Equations
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.50
	Confidence Interval	() 95%; 2.17 to 9.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Pain-Free Assessment at 2 Hours Post-dose
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
Number [Participants]	23 16%	54 NaN

3. Secondary Outcome

Title	Rescue Medication Used up to 24 Hours Post-dose
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
Number [Participants]	84 58.3%	40 NaN

4. Secondary Outcome

Title	Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
1/2 hour post-dose	2 1.4%	6 NaN
1 hour post-dose	13 9%	26 NaN
4 hours post-dose	30 20.8%	80 NaN
8 hours post-dose	32 22.2%	88 NaN

5. Secondary Outcome

Title	Sustained Freedom From Migraine
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
Number [Participants]	11 7.6%	32 NaN

6. Secondary Outcome

Title	Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
2 hours post-dose	19 13.2%	47 NaN
4 hours post-dose	30 20.8%	72 NaN
8 hours post-dose	29 20.1%	80 NaN

7. Secondary Outcome

Title	Sustained Freedom From Migraine-Associated Sinus Pain
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
Number [Participants]	34 23.6%	76 NaN

8. Secondary Outcome

Title	Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Description	Number of participants who had sinus pain at the time of assessment.
Time Frame	Baseline, 2, 4, and 8 hours post-dose

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
Baseline	58 40.3%	61 NaN
2 hours post-dose	52 36.1%	31 NaN
4 hours post-dose	39 27.1%	20 NaN
8 hours post-dose	35 24.3%	19 NaN

9. Secondary Outcome

Title	Sustained Freedom From Migraine-Associated Neck Pain
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
Number [Participants]	33 22.9%	63 NaN

10. Secondary Outcome

Title	Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Description	Number of Participants with neck pain at the time of assessment.
Time Frame	Baseline, 2, 4, and 8 hours post-dose

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
Baseline	65 45.1%	82 NaN
2 hours post-dose	54 37.5%	54 NaN
4 hours post-dose	46 31.9%	40 NaN
8 hours post-dose	37 25.7%	31 NaN

11. Secondary Outcome

Title	Sustained Freedom From Migraine-Associated Photophobia
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
Number [Participants]	23 16%	59 NaN

12. Secondary Outcome

Title	Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
Baseline	98 68.1%	95 NaN
2 hours post-dose	86 59.7%	57 NaN
4 hours post-dose	65 45.1%	33 NaN
8 hours post-dose	48 33.3%	27 NaN

13. Secondary Outcome

Title	Sustained Freedom From Migraine-Associated Phonophobia
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
Number [Participants]	31 21.5%	66 NaN

14. Secondary Outcome

Title	Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
Baseline	82 56.9%	86 NaN
2 hours post-dose	73 50.7%	47 NaN
4 hours post-dose	56 38.9%	31 NaN
8 hours post-dose	44 30.6%	24 NaN

15. Secondary Outcome

Title	Sustained Freedom From Migraine-Associated Nausea
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
Number [Participants]	38 26.4%	70 NaN

16. Secondary Outcome

Title	Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
Baseline	45 31.3%	48 NaN
2 hours post-dose	42 29.2%	39 NaN
4 hours post-dose	29 20.1%	20 NaN
8 hours post-dose	24 16.7%	14 NaN

17. Secondary Outcome

Title	Sustained Complete Pain/Symptom-Free
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
Number [Participants]	9 6.3%	30 NaN

18. Secondary Outcome

Title	Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	133	136
Baseline	133 92.4%	136 NaN
2 hours post-dose	117 81.3%	92 NaN
4 hours post-dose	107 74.3%	73 NaN
8 hours post-dose	106 73.6%	62 NaN

19. Secondary Outcome

Title	Recurrence of Any Migraine Headache Pain
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

Outcome Measure Data

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
Arm/Group Description
Measure Participants	23	54
Recurrence by 24 hours post-dose	12 8.3%	11 NaN
Recurrence by 48 hours post-dose	13 9%	11 NaN

Adverse Events

Arm/Group Title	Placebo		Sumatriptan-Naproxen Sodium
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Sumatriptan-Naproxen Sodium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/135 (0%)		0/140 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Sumatriptan-Naproxen Sodium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/135 (0%)		0/140 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.