Clinical Trial: Drotaverine in Dysmenorrhoea Treatment

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Comparison of the Efficacy and Tolerability of Drotaverine 80 mg, Ibuprofen 400 mg and Their Combination in a Calendar Packaging for the Treatment of Primary and Secondary Dysmen

Brief Summary: The aim of the study is to show that the combination of drotaverine 80mg and ibuprofen 400 mg is more effective and as well-tolerated as ibuprofen 400 mg or drotaverine 80 mg administered alone, in the treatment of primary and secondary dysmenorrhoea.

Detailed Summary:
Sponsor: Sanofi

Current Primary Outcome: Reponse rate in each treatment arm: proportion of patients having pain intensity score 0 or 1 at hour 2 after the first drug intake.

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sanofi

Dates:
Date Received: February 15, 2006
Date Started: May 2005
Date Completion:
Last Updated: November 14, 2008
Last Verified: November 2008