Status:
COMPLETED
TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Migraine Disorders
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 13 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00385008
Start Date
September 13 2006
End Date
November 24 2006
Last Update
February 12 2018
Active Locations (1)
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1
GSK Investigational Site
Lexington, Kentucky, United States, 40503