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ClinicalTrials.gov public records Last synced Oct 19, 2026, 1:36 AM EDT

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Showing 1–24 of 33 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Sumatriptan/Naproxen Sodium Clear all
Completed Phase 1 Interventional Accepts healthy volunteers

An Open-label, Randomized, 3-period Crossover Study to Evaluate Sumatriptan Pharmacokinetics for a TREXIMA™ (Sumatriptan Succinate / Naproxen Sodium) Tablet Followed by IMITREX® (Sumatriptan Succinate)

NCT00875784
View directory record Official record
Conditions
Migraine Disorders
Interventions
TREXIMA™, IMITREX® (4mg), IMITREX® (6mg), IMITREX Tablet 100mg
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years to 55 Years
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008
U.S. locations
1
States / cities
Tacoma, Washington
Source: ClinicalTrials.gov public record
Updated Aug 4, 2017 · Synced Oct 19, 2026, 1:36 AM EDT
Terminated Phase 4 Interventional Results available

Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction

NCT01053507
View directory record Official record
Conditions
Post-Traumatic Headache
Interventions
sumatriptan/naproxen sodium, Placebo
Drug
Lead sponsor
Cady, Roger, M.D.
Individual
Eligibility
18 Years to 65 Years
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2012
U.S. locations
3
States / cities
Springfield, Missouri • Nashville, Tennessee • Temple, Texas
Source: ClinicalTrials.gov public record
Updated Jul 29, 2020 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 4 Interventional

Migraine Treatment Satisfaction With Treximet Versus Concomitant 2 Aleve and Imitrex

NCT01450995
View directory record Official record
Conditions
Migraine
Interventions
Treximet, Imitrex and two Aleve
Drug
Lead sponsor
Stephen H. Landy, M.D.
Other
Eligibility
18 Years to 65 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
1
States / cities
Memphis, Tennessee
Source: ClinicalTrials.gov public record
Updated Oct 13, 2011 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Pharmacokinetic Study to Evaluate TREXIMET in Adolescents With Migraine and Healthy Subjects Administered at Three Doses.

NCT00989625
View directory record Official record
Conditions
Migraine Disorders
Interventions
This is a pharmacokinetic study (Treximet)
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
12 Years to 55 Years
Enrollment
50 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008 – 2009
U.S. locations
3
States / cities
Wichita, Kansas • Louisville, Kentucky • Memphis, Tennessee
Source: ClinicalTrials.gov public record
Updated Jun 19, 2017 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 4 Interventional Results available

CGRP, Estrogen, Cortisol, VIP, α-Amylase, PGE2, PGI2 and ß-Endorphin Levels in Menstrual Migraine Before and After Treximet

NCT01329562
View directory record Official record
Conditions
Menstrual Migraine
Interventions
Treximet, Placebo
Drug
Lead sponsor
Cady, Roger, M.D.
Individual
Eligibility
18 Years to 45 Years · Female only
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2012
U.S. locations
2
States / cities
Springfield, Missouri • Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Apr 9, 2014 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 3 Interventional

To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches

NCT00434083
View directory record Official record
Conditions
Migraine Headaches
Interventions
sumatriptan, naproxen sodium
Drug
Lead sponsor
POZEN
Industry
Eligibility
18 Years to 65 Years
Enrollment
1,200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2005
U.S. locations
2
States / cities
Chapel Hill, North Carolina • Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Feb 12, 2007 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 3 Interventional

Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks

NCT00240630
View directory record Official record
Conditions
Migraine Disorders, Migraine
Interventions
sumatriptan succinate/naproxen sodium, placebo
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years to 65 Years
Enrollment
646 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2006
U.S. locations
50
States / cities
Chandler, Arizona • Phoenix, Arizona • Little Rock, Arkansas + 45 more
Source: ClinicalTrials.gov public record
Updated Apr 16, 2015 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Treximet Early Intervention Adolescent Migraine

NCT01016678
View directory record Official record
Conditions
Migraine
Interventions
Treximet, Placebo
Drug
Lead sponsor
Premiere Research Institute
Other
Eligibility
12 Years to 17 Years
Enrollment
104 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2014
U.S. locations
4
States / cities
West Palm Beach, Florida • Cincinnati, Ohio • Dallas, Texas + 1 more
Source: ClinicalTrials.gov public record
Updated May 4, 2016 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 3 Interventional

Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

NCT00329355
View directory record Official record
Conditions
Migraine, Migraine Disorders
Interventions
sumatriptan succinate/naproxen sodium
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years to 65 Years · Female only
Enrollment
351 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006
U.S. locations
35
States / cities
Chandler, Arizona • Irvine, California • Redondo Beach, California + 30 more
Source: ClinicalTrials.gov public record
Updated Jan 23, 2017 · Synced Oct 19, 2026, 1:36 AM EDT
Completed No phase listed Observational Accepts healthy volunteers

Comparison of Treximet & Imitrex as They Affect the Levels of Inflammatory Markers When the Patient is Actively Having a Migraine Headache

NCT01916395
View directory record Official record
Conditions
Migraine
Interventions
sumatriptan and Treximet
Drug
Lead sponsor
Gary E. Ruoff, M.D.
Other
Eligibility
18 Years to 65 Years
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009 – 2011
U.S. locations
1
States / cities
Kalamazoo, Michigan
Source: ClinicalTrials.gov public record
Updated Aug 5, 2013 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 4 Interventional Results available

Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine

NCT01300546
View directory record Official record
Conditions
Migraine
Interventions
Sumatriptan/Naproxen Sodium, Naproxen Sodium
Drug
Lead sponsor
Cady, Roger, M.D.
Individual
Eligibility
18 Years to 65 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2012
U.S. locations
2
States / cities
Newport Beach, California • Springfield, Missouri
Source: ClinicalTrials.gov public record
Updated May 21, 2013 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 4 Interventional Results available

Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response?

NCT01086358
View directory record Official record
Conditions
Workplace Migraine Treatment
Interventions
Triptan, Treximet 85Mg-500Mg Tablet
Drug
Lead sponsor
The Cleveland Clinic
Other
Eligibility
18 Years and older
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2016
U.S. locations
1
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated May 1, 2018 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 4 Interventional Results available

Comparing Naproxen to Sumatriptan for Emergency Headache Patients

NCT00449787
View directory record Official record
Conditions
Migraine, Tension-type Headache, Primary Headache Disorder
Interventions
Sumatriptan 100 mg, Naproxen
Drug
Lead sponsor
Montefiore Medical Center
Other
Eligibility
18 Years to 65 Years
Enrollment
401 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2009
U.S. locations
2
States / cities
New York, New York • The Bronx, New York
Source: ClinicalTrials.gov public record
Updated May 31, 2018 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 3 Interventional

Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea

NCT00329459
View directory record Official record
Conditions
Migraine Disorders
Interventions
sumatriptan succinate/naproxen sodium, placebo
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years to 65 Years · Female only
Enrollment
320 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006
U.S. locations
34
States / cities
Mesa, Arizona • Little Rock, Arkansas • Fair Oaks, California + 31 more
Source: ClinicalTrials.gov public record
Updated Oct 24, 2016 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 3 Interventional Results available

Migraine Study in Adolescent Patients

NCT00843024
View directory record Official record
Conditions
Migraine Disorders
Interventions
Sumatriptan and Naproxen Sodium, Placebo
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
12 Years to 17 Years
Enrollment
589 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
79
States / cities
Gilbert, Arizona • Litchfield Park, Arizona • Phoenix, Arizona + 71 more
Source: ClinicalTrials.gov public record
Updated Jan 18, 2017 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 3 Interventional Results available

TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine

NCT00385008
View directory record Official record
Conditions
Migraine Disorders
Interventions
Combination Product (sumatriptan succinate / naproxen sodium), RELPAX(eletriptan) 40mg Tablet
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years to 55 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006
U.S. locations
1
States / cities
Lexington, Kentucky
Source: ClinicalTrials.gov public record
Updated Feb 12, 2018 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 3 Interventional

To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migraine Headaches

NCT00433732
View directory record Official record
Conditions
Migraine Headaches
Interventions
sumatriptan, naproxen sodium
Drug
Lead sponsor
POZEN
Industry
Eligibility
18 Years to 65 Years
Enrollment
1,400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2005
U.S. locations
2
States / cities
Little Rock, Arkansas • Chapel Hill, North Carolina
Source: ClinicalTrials.gov public record
Updated Feb 12, 2007 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 3 Interventional Results available

TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)

NCT00387881
View directory record Official record
Conditions
Migraine, Without Aura
Interventions
sumatriptan succinate / naproxen sodium, Placebo
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years to 65 Years
Enrollment
679 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2008
U.S. locations
70
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Anaheim, California + 58 more
Source: ClinicalTrials.gov public record
Updated Dec 16, 2016 · Synced Oct 19, 2026, 1:36 AM EDT
Completed No phase listed Observational

Treatments of Migraine with Triptans in Individuals with Elevated Cardiovascular Risk and in Pregnant Women

NCT05854992
View directory record Official record
Conditions
Migraine, Cardiovascular Diseases, Pregnancy
Interventions
Acute migraine treatment with any prescribed triptans, Standard of care management of acute migraine without triptans
Drug
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older
Enrollment
68,419 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
3
States / cities
Phoenix, Arizona • Jacksonville, Florida • Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Dec 2, 2024 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 3 Interventional

The Safety Of Combo Formulation In The Treatment Of Multiple Episodes Of Acute Migraine Over 12 Months

NCT00442221
View directory record Official record
Conditions
Migraine Headaches
Interventions
Sumatriptan and Naproxen sodium
Drug
Lead sponsor
POZEN
Industry
Eligibility
18 Years to 65 Years
Enrollment
500 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004
U.S. locations
2
States / cities
Chapel Hill, North Carolina • Greensboro, North Carolina
Source: ClinicalTrials.gov public record
Updated Mar 1, 2007 · Synced Oct 19, 2026, 1:36 AM EDT
Not listed Not applicable Interventional Accepts healthy volunteers

Efficacy of Sumatriptan With Naprosyn in Migraine With Aura

NCT00893594
View directory record Official record
Conditions
Migraine With Aura
Interventions
sumatriptan with naprosyn, placebo
Drug
Lead sponsor
Dent Neurologic Institute
Other
Eligibility
18 Years to 50 Years
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010 – 2015
U.S. locations
1
States / cities
Amherst, New York
Source: ClinicalTrials.gov public record
Updated Feb 19, 2015 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 3 Interventional Results available

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

NCT00573170
View directory record Official record
Conditions
Migraine Disorders, Migraine, Acute
Interventions
TREXIMET®, Butalbital-containing Combination Medications (BCM), placebo
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years to 65 Years
Enrollment
375 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
107
States / cities
Chandler, Arizona • Gilbert, Arizona • Litchfield Park, Arizona + 94 more
Source: ClinicalTrials.gov public record
Updated Dec 29, 2010 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 4 Interventional Results available

Ictal and Interictal Inflammatory Markers in Migraine

NCT01138150
View directory record Official record
Conditions
Migraine
Interventions
Treximet, Placebo
Drug
Lead sponsor
Johns Hopkins University
Other
Eligibility
18 Years to 55 Years
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2013
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Oct 6, 2016 · Synced Oct 19, 2026, 1:36 AM EDT
Completed Phase 4 Interventional Results available

Treximet in the Treatment of Chronic Migraine

NCT01090050
View directory record Official record
Conditions
Chronic Migraine
Interventions
Sumatriptan/Naproxen Sodium, Naproxen Sodium
Drug
Lead sponsor
Cady, Roger, M.D.
Individual
Eligibility
18 Years to 65 Years
Enrollment
56 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2012
U.S. locations
2
States / cities
Springfield, Missouri • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Jul 3, 2013 · Synced Oct 19, 2026, 1:36 AM EDT