Clinical Trial: Migraine Study in Adolescent Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Tre

Brief Summary: This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old

Detailed Summary: The purpose of this study is to determine whether the combination product, sumatriptan and naproxen sodium, is effective compared to placebo in the treatment of acute migraine in adolescent subjects 12-17 years old. Subjects will treat two migraine attacks over a ~25 week period.
Sponsor: GlaxoSmithKline

Current Primary Outcome: Number of Participants Who Were Pain Free at 2 Hours Post-dose [ Time Frame: 2 hours after single dose of double-blind treatment (Randomization through Week 13) ]

Original Primary Outcome: Efficacy (pain intensity as measured by scores on a 4-point rating scale) [ Time Frame: 2 hours post treatment ]

Current Secondary Outcome:

• Number of Participants Sustained Pain-free From 2-24 Hours [ Time Frame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  Participants with sustained pain-freedom were defined as those with pain-freedom at 2 hours post-dose that was maintained up to 24 hours post-treatment without the use of rescue medication.
• Number of Participants Photophobia-free at 2 Hours Post-dose [ Time Frame: 2 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  The number of participants who did not have photophobia (sensitivity to light) at 2 hours post dose was analyzed.
• Number of Participants Phonophobia-free at 2 Hours Post-dose [ Time Frame: 2 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  The number of participants who did not have phonophobia (sensitivity to sound) at 2 hours post dose was analzyed.
• Number of Participants Pain-free at 1 Hour Post-dose [ Time Frame: 1 hour after single dose of double-blind treatment (Randomization through Week 13) ]
  Participants with a pain-free response at 1 hour post-dose were considered as those who had a reduction in migraine headache pain from moderate (a score of 2) or severe (a score of 3) at baseline to none (a score of 0) post-treatment, without the use of rescue medication prior to or at 1 hour post dose.
• Number of Participants Sustained Photophobia-free From 2-24 Hours [ Time Frame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  Participants with sustained freedom from photophobia were those with an absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose without the use of rescue medication.
• Number of Participants Sustained Phonophobia-free From 2-24 Hours [ Time Frame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  Participants with sustained freedom from phonophobia were those with an absence of phonophobia (sensitivity to sound) from 2 to 24 hours post-dose without the use of rescue medication.
• Number of Participants Sustained Nausea-free From 2-24 Hours [ Time Frame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  Participants with sustained freedom from nausea were those with an absence of nausea from 2 to 24 hours post-dose without the use of rescue medication.
• Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose [ Time Frame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with investigational product. Permitted rescue medications included oral naproxen sodium (maximum 15 mg/kg), oral over-the-counter pain reliever, and anti-emetics. This outcome measure included only participants who rescued from 2 to 24 hours post-dose, inclusive.
• Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points [ Time Frame: Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with double-blind treatment. In addition to participants who rescued from 2 to 24 hours post-dose, inclusive, this outcome measure also included nine protocol violators who rescued < 2 hours post-treatment.
• Number of Participants Nausea-free at 2 Hours Post-dose [ Time Frame: 2 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  The number of participants who did not have nausea at 2 hours post dose was analzyed.

Original Secondary Outcome:

• Migraine symptomatology (pain intensity as measured by scores on a 4-point rating scale for photo- and photophobia, nausea and rescue medication use) [ Time Frame: 2-24 hours post treatment ]
• Efficacy (pain intensity as measured by scores on a 4-point rating scale) [ Time Frame: 1 hour post treatment ]

Dates:
Date Received: February 12, 2009
Date Started: December 2008
Date Completion:
Last Updated: November 30, 2016
Last Verified: November 2016