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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)

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Combination Product (sumatriptan succinate / naproxen sodium)
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring Combination Product, naproxen sodium, sumatriptan succinate, short acting triptan, migraine, acute, Poor response

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Combination Product - Placebo

Placebo - Combination Product

Arm Description

Combination product (sumatriptan and naproxen sodium) [Attack 1] followed by placebo [Attack 2]

Placebo [Attack 1] followed by Combination Product (sumatriptan and naproxen sodium) [Attack 2]

Outcomes

Primary Outcome Measures

Sustained Freedom From Migraine Pain Between 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

Pain-Free Assessment at 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.
Rescue Medication Used up 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).
Pain-Free Assessment at 1/2, 1, 4, 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.
Sustained Freedom From Migraine
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.
Migraine-Free Assessment at 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.
Sustained Freedom From Migraine-Associated Sinus Pain
Sustained Freedom from Migraine-Associated Sinus Pain was defined as the absence of sinus pain from 2 to 24 hours post-dose.
Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Number of participants who had sinus pain at the time of assessment.
Sustained Freedom From Migraine-Associated Neck Pain
Sustained Freedom from Migraine-Associated Neck Pain was defined as the absence of neck pain from 2 to 24 hours post-dose.
Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Number of Participants with neck pain at the time of assessment.
Sustained Freedom From Migraine-Associated Photophobia
Sustained Freedom from Migraine-Associated Photophobia was defined as the absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose.
Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Number of participants who had photophobia (sensitivity to light) at the time of assessment.
Sustained Freedom From Migraine-Associated Phonophobia
Sustained Freedom from Migraine-Associated Phonophobia was defined as the absence of phonophobia (sensitivity to noise) from 2 to 24 hours post-dose.
Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
Number of participants who had phonophobia (sensitivity to noise) at the time of assessment.
Sustained Freedom From Migraine-Associated Nausea
Sustained Freedom from Migraine-Associated Nausea was defined as the absence of nausea from 2 to 24 hours post-dose.
Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose
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.
Sustained Complete Pain/Symptom-Free
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.
Complete Pain/Symptom-Free Assessed at 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.
Recurrence of Any Migraine Headache Pain
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.

Full Information

First Posted
September 29, 2006
Last Updated
December 2, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00383162
Brief 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)
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 Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. 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]
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
Combination Product, naproxen sodium, sumatriptan succinate, short acting triptan, migraine, acute, Poor response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination Product - Placebo
Arm Type
Other
Arm Description
Combination product (sumatriptan and naproxen sodium) [Attack 1] followed by placebo [Attack 2]
Arm Title
Placebo - Combination Product
Arm Type
Other
Arm Description
Placebo [Attack 1] followed by Combination Product (sumatriptan and naproxen sodium) [Attack 2]
Intervention Type
Drug
Intervention Name(s)
Combination Product (sumatriptan succinate / naproxen sodium)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablet.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
GSK Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
GSK Investigational Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
GSK Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
GSK Investigational Site
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
GSK Investigational Site
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
GSK Investigational Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
GSK Investigational Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
GSK Investigational Site
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
GSK Investigational Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
GSK Investigational Site
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
GSK Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
GSK Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
GSK Investigational Site
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Facility Name
GSK Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
GSK Investigational Site
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
GSK Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
GSK Investigational Site
City
Tabor City
State/Province
North Carolina
ZIP/Postal Code
28463
Country
United States
Facility Name
GSK Investigational Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
GSK Investigational Site
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
GSK Investigational Site
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24013
Country
United States
Facility Name
GSK Investigational Site
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
19486178
Citation
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.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TRX106571
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TRX106571
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TRX106571
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TRX106571
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TRX106571
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TRX106571
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TRX106571
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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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