NCT00573170|CompletedPhase 3Results

TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) vs. Butalbital-containing Combination Medications for the Acute Treatment of Migraine When Administered During the Moderate-Severe Migraine Pain, Studies 1 and 2 of 2

GlaxoSmithKline ClinicalTrials.gov

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1 other identifier

TRX109011/TRX109013

Study Type

interventional

Target

375

Locations

1 country

Sites

107

Timeline

RegisteredDec 2007

StartedFeb 2008

CompletionAug 2009

Brief Summary

Study TRX109011/TRX109013, A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) versus Butalbital-containing Combination Medications (BCM) for the Acute Treatment of Migraine when administered during the Moderate-Severe Pain Phase of the Migraine (Studies 1 and 2 of 2)

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

375

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Feb 2008

Geographic Reach

1 country

107 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

December 12, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed

2 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

December 29, 2010

Completed

Last Updated

December 29, 2010

Status Verified

November 1, 2010

Enrollment Period

1.5 years

First QC Date

December 12, 2007

Results QC Date

August 16, 2010

Last Update Submit

November 30, 2010

Conditions

Migraine Disorders Migraine, Acute

Keywords

Migraine, acuteMigraineButalbital-containing Combination Medication (BCM)Naproxen sodiumSumatriptan succinateTREXIMET®

Outcome Measures

Primary Outcomes (1)

Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose
SPF 2-24 hours is defined for all participants as having no pain at 2 hours post-dose and without the return of any pain or the use of any rescue medication (any medication taken after the first dose of study medication for any migraine pain or symptoms) from 2-24 hours.
From 2 to 24 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).

Secondary Outcomes (22)

Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose
At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Number of Participants Using Rescue Medication Within 48 Hours Post Dose
From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Mean Time to First Use of Rescue Medication for the First Attack Treated With Study Medication (Attack 1)
From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Mean Time to First Use of Rescue Medication for the Second Attack Treated With Study Medication (Attack 2)
From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Mean Time to First Use of Rescue Medication for the Third Attack Treated With Study Medication (Attack 3)
From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
+17 more secondary outcomes