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Efficacy of Combination Product (Sumatriptan Succinate/Naproxen Sodium) in Eletriptan Non-Responders.
This study has been completed.
Study NCT00383162   Information provided by GlaxoSmithKline
First Received: September 29, 2006   Last Updated: August 20, 2008   History of Changes

September 29, 2006
August 20, 2008
October 2006
 
Proportion of subjects with Sustained Pain Free between 2-24hrs post dose.
Same as current
Complete list of historical versions of study NCT00383162 on ClinicalTrials.gov Archive Site
Migraine with or without aura (ICHD-II Criteria 1.2 or 1.1).
Same as current
 
Efficacy of Combination Product (Sumatriptan Succinate/Naproxen Sodium) in Eletriptan Non-Responders.
A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Eletriptan (Study 1 of 2)

Studies have been done to evaluate the efficacy of several triptans in patients who do not respond to sumatriptan. This study is a new concept to evaluate the new Combination Product in patients who do not respond to eletriptan.

 
Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Migraine
Drug: Combination Product (sumatriptan succinate / naproxen sodium)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
167
 
 

Inclusion Criteria:

  • Consented males and nonpregnant females using adequate contraception, between 18 and 65 years of age, with at least 1-8 migraines per month for past 3 months. Eligible subjects must have been discontinued from eletriptan treatment within the past year due to poor response and/or intolerance. Subjects were 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; opioid narcotics in past 6 months, had evidence of alcohol or substance abuse; recent gastric bypass surgery or other GI bleeding disorders, inflammatory bowel disease; ACE inhibitors; 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00383162
Deo S. Bukenya, Pharm.D., GlaxoSmithKline
TRX106571
GlaxoSmithKline
 
Study Chair: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP