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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00599157 |
Purpose
Study 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 (Study 2 of 2)
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine Migraine, Acute |
Drug: Butalbital-containing Combination Medication (BCM) Drug: TREXIMET® Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study |
| Official Title: | See Section 5 Brief Summary |
| Enrollment: | 396 |
| Study Start Date: | December 2007 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
PBT
placebo (Attack 1), BCM (Attack 2), TREXIMET® (Attack 3)
|
Drug: Butalbital-containing Combination Medication (BCM)
butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) [currently marketed as Fioricet]
Drug: TREXIMET®
Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate [equivalent to sumatriptan 85mg] and naproxen sodium 500mg)
Drug: Placebo
placebo
|
|
PTB
placebo (Attack 1), TREXIMET® (Attack 2), BCM (Attack 3),
|
Drug: Butalbital-containing Combination Medication (BCM)
butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) [currently marketed as Fioricet]
Drug: TREXIMET®
Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate [equivalent to sumatriptan 85mg] and naproxen sodium 500mg)
Drug: Placebo
placebo
|
|
BTP
BCM (Attack 1), TREXIMET® (Attack 2), placebo (Attack 3)
|
Drug: Butalbital-containing Combination Medication (BCM)
butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) [currently marketed as Fioricet]
Drug: TREXIMET®
Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate [equivalent to sumatriptan 85mg] and naproxen sodium 500mg)
Drug: Placebo
placebo
|
|
BPT
BCM (Attack 1), placebo (Attack 2), TREXIMET® (Attack 3)
|
Drug: Butalbital-containing Combination Medication (BCM)
butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) [currently marketed as Fioricet]
Drug: TREXIMET®
Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate [equivalent to sumatriptan 85mg] and naproxen sodium 500mg)
Drug: Placebo
placebo
|
|
TBP
TREXIMET® (Attack 1), BCM (Attack 2), placebo (Attack 3)
|
Drug: Butalbital-containing Combination Medication (BCM)
butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) [currently marketed as Fioricet]
Drug: TREXIMET®
Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate [equivalent to sumatriptan 85mg] and naproxen sodium 500mg)
Drug: Placebo
placebo
|
|
TPB
TREXIMET® (Attack 1), placebo (Attack 2), BCM (Attack 3)
|
Drug: Butalbital-containing Combination Medication (BCM)
butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) [currently marketed as Fioricet]
Drug: TREXIMET®
Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate [equivalent to sumatriptan 85mg] and naproxen sodium 500mg)
Drug: Placebo
placebo
|
This study is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, crossover, three-attack, outpatient study in which TREXIMET® will be compared to a butalbital-containing Combination Medication (BCM: acetaminophen 325mg, caffeine 40mg, and butalbital 50mg [Fioricet]) for the acute treatment of migraine headaches. Subjects will be randomized to one of 6 possible treatment sequences (TPB, TBP, BTP, BPT, PTB, PBT where T = TREXIMET®, P = Placebo, B = Butalbital-containing Combination Medication). Subjects will treat each of the 3 migraine attacks when pain is moderate to severe. The study will include 4 visits: (1) a Screening Visit at study entry, (2) a Drug Screen Visit, (3) a Randomization Visit, and (4) a Final Visit. The Final Visit occurs either (A) upon withdrawal or (B) after treatment of 3 migraine attacks. The primary objective is to evaluate the efficacy of TREXIMET® versus BCM for the acute treatment of moderate/severe migraine.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and females aged 18 to 65 years. Female subjects are eligible for participation if they are either of non-childbearing potential (not capable of becoming pregnant) OR of childbearing potential having a negative urine pregnancy test at screening, and using contraception if sexually active. If using oral contraceptives, the subjects should be on a stable regimen of oral contraceptives (>/= 2 months).
Eligible subjects must:
Exclusion Criteria:
A subject is not eligible if they have:
Contacts and Locations
Show 50 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | TRX109013 |
| Study First Received: | January 10, 2008 |
| Last Updated: | January 28, 2010 |
| ClinicalTrials.gov Identifier: | NCT00599157 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Migraine Butalbital-containing Combination Medication (BCM) Sumatriptan succinate |
Naproxen sodium Migraine, acute TREXIMET® |
|
Serotonin Agonists Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Headache Disorders, Primary Cardiovascular Agents |
Brain Diseases Pharmacologic Actions Headache Disorders Sumatriptan Serotonin Agents Migraine Disorders Therapeutic Uses Vasoconstrictor Agents |