TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00385008

First received: October 4, 2006

Last updated: October 24, 2016

Last verified: October 2016

History of Changes

Purpose

An evaluation of tablet disintegration and absorption and gastric transit of sumatriptan and naproxen sodium from a TREXIMA tablet and eletriptan from a RELPAX 40mg tablet.

Condition	Intervention	Phase
Migraine Disorders	Drug: Combination Product (sumatriptan succinate / naproxen sodium) Drug: RELPAX(eletriptan) 40mg Tablet	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	An Open Label, Single Dose, Parallel Group Study to Evaluate Absorption and Transit Characteristics of TREXIMA and RELPAX in Patients Inside and Outside of an Acute Migraine Attack.

Resource links provided by NLM:

MedlinePlus related topics: Migraine

Drug Information available for: Succinic acid Naproxen Naproxen sodium Sumatriptan Sumatriptan succinate Eletriptan Eletriptan Hydrobromide

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

tablet disintegration, transit throught the gastrointestinal tract, pharmacokinetic parameters both during a migraine and when not experiencing a migraine [ Time Frame: acute treatment ]

Secondary Outcome Measures:

safety and adverse experiences [ Time Frame: acute treatment ]


Enrollment:	20
Study Start Date:	September 2006
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1 open-label active drug	Drug: Combination Product (sumatriptan succinate / naproxen sodium) sumatriptan/naproxen sodium
Arm 2 open-label active drug	Drug: RELPAX(eletriptan) 40mg Tablet eletriptan tablets Other Name: Combination Product (sumatriptan succinate / naproxen sodium)

Eligibility


Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Consented males and nonpregnant females using adequate contraception, between 18 and 55 years of age, with at least 1-6 migraines per month for past 6 months. Subjects will be excluded for confirmed or suspected ischemic heart disease, uncontrolled hypertension at screening; a history of epilepsy or structural brain lesions which lowered the convulsive threshold; confirmed or suspected cardiovascular, cerebrovascular, peripheral vascular, congenital heart disease, or ischemic bowel disease; impaired hepatic or renal function; basilar or hemiplegic migraine. Other exclusion criteria included use of a monoamine oxidase inhibitor within 2 weeks before screening; ergot prophylactics in past 3 months; anticoagulants; smoking more than 10 cigarettes/day, evidence of alcohol or substance abuse; GI bleeding disorders, inflammatory bowel disease; or any concurrent medical or psychiatric condition that in the investigator's opinion could affect interpretation of efficacy or safety information or which otherwise contraindicated participation in the study.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00385008

Locations


United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40503

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Kori S, Byrd S, Doll W, Page R, and Sandefer E. Gastric Emptying and Absorption of a Sumatriptan with RT Technology 85mg and Naproxen Sodium 500mg Tablet. Cephalalgia 2007; Vol 27; 649.

Kori S, Byrd S, Doll W, Page R, and Sandefer E. Gastroscintigraphic Evaluation of Gastric Emptying and Absorption of Another Conventionally Formulated Triptan. Cephalalgia 2007; Vol 27; 730.

Kori S, Byrd SC, Doll WJ, Page RC, and Sandefer EP. Gastric Transit and Absorption of Sumatriptan and Naproxen from a Fixed Single-Tablet Sumatriptan RT Technology 85mg and Naproxen Sodium 500mg in Migraineurs both During and Outside a Migraine Attack: Evaluation by Gastric Scintigraphy. Headache 2007; 47(5):751.

Kori S, Doll WJ, Page RC, Byrd SC, Sandefer EP. Gastric Transit and Absorption of Eletriptan, another Conventionally Formulated Triptan, in Migraineurs both During and Outside a Migraine Attack: Evaluation by Gastric Scintigraphy. Headache 2007; 47(5):752.

Study Data/Documents: Individual Participant Data Set This link exits the ClinicalTrials.gov site