NCT00573170 is a Phase 3 clinical trial of TREXIMET® in Migraine Disorders, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00573170?

NCT00573170 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00573170?

Interventions in NCT00573170: TREXIMET®, Butalbital-containing Combination Medications (BCM), placebo.

What condition does NCT00573170 study?

NCT00573170 studies Migraine Disorders, Migraine, Acute.

Is NCT00573170 still recruiting?

NCT00573170 is currently completed. Last updated 30 November 2010.

Are results published for NCT00573170?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2010-11-30 · How we verify

NCT00573170

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 30 November 2010

What this trial tests

Phase 3 trial testing TREXIMET® in Migraine Disorders in 375 participants. Completed in 1 August 2009.

Timeline

1 February 2008

Primary endpoint
1 August 2009

1 August 2009

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	375
Start date	1 February 2008
Primary completion	1 August 2009
Estimated completion	1 August 2009
Sites	107 locations across United States

Drugs / interventions tested

TREXIMET®
Butalbital-containing Combination Medications (BCM) — full drug profile →
placebo

Conditions studied

Migraine Disorders — all drugs for Migraine Disorders →
Migraine, Acute — all drugs for Migraine, Acute →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Migraine Disorders or Migraine, Acute. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose
Time frame: 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).
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.

Sponsor's own description

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)

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Migraine Disorders

Currently open trials in the same condition.

NCT07170176 — Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine · NA · recruiting
NCT07093138 — Evaluation of Efficacy and Safety of Topical Cannabidiol (Canvert-M Produced by Alasht Pharmed co. Iran) in the Treatmen · Phase 4 · recruiting
NCT06426316 — The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology. · NA · recruiting
NCT06623188 — Treatment of Episodic Migraine With AURICular Neuromodulation · NA · recruiting
NCT06535880 — Trigeminal Brainstem Mapping 2: Higher Cortical Strucureas As Well As Subnuclei of the Spinal Trigeminal Nucleus · NA · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00573170 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 30 November 2010

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00573170.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing