TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-13

Study Completion Date

2006-11-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Migraine Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

open-label active drug

Group Type OTHER

Combination Product (sumatriptan succinate / naproxen sodium)

Intervention Type DRUG

sumatriptan/naproxen sodium

Arm 2

open-label active drug

Group Type OTHER

RELPAX(eletriptan) 40mg Tablet

Intervention Type DRUG

eletriptan tablets

Interventions

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Combination Product (sumatriptan succinate / naproxen sodium)

sumatriptan/naproxen sodium

Intervention Type DRUG

RELPAX(eletriptan) 40mg Tablet

eletriptan tablets

Intervention Type DRUG

Other Intervention Names

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Combination Product (sumatriptan succinate / naproxen sodium)

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Lexington, Kentucky, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Study Documents

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