TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine - Full Text View

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 With or Without Aura Migraine Disorders	Drug: Combination Product (sumatriptan succinate / naproxen sodium) Drug: RELPAX(eletriptan) 40mg Tablet	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety and adverse experiences [ Time Frame: acute treatment ] [ Designated as safety issue: No ]


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 Names: RELPAX(eletriptan) 40mg Tablet Combination Product (sumatriptan succinate / naproxen sodium)

Eligibility


Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:

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.

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, 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 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.


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00385008 History of Changes
Other Study ID Numbers:	TRX105848
Study First Received:	October 4, 2006
Last Updated:	May 31, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:


Combination product, sumatriptan succinate, naproxen sodium, absorption, pharmacokinetics, disintegration, gastric transit, gastric scintigraphy

Additional relevant MeSH terms:


Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases Eletriptan Naproxen Sumatriptan Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antirheumatic Agents Cardiovascular Agents	Central Nervous System Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Gout Suppressants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Serotonin 5-HT1 Receptor Agonists Serotonin Agents Serotonin Receptor Agonists Therapeutic Uses Vasoconstrictor Agents

ClinicalTrials.gov processed this record on March 03, 2015