TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine
Information source: Pozen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine With or Without Aura
Intervention: Combination Product (sumatriptan succinate / naproxen sodium) (Drug); RELPAX(eletriptan) 40mg Tablet (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pozen
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.
Clinical Details
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.
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Bio-availability Study
Primary outcome: tablet disintegration, transit throught the gastrointestinal tract, pharmacokinetic parameters both during a migraine and when not experiencing a migraine
Secondary outcome: safety and adverse experiences
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Scintipharma, Inc., Lexington, Kentucky 40503, United States
Additional Information
Starting date: September 2006
Last updated: December 18, 2007
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