A Study to Determine the Effect of Nitroglycerin Ointment on the Pain Associated With Chronic Anal Fissures
Anal fissure is a solitary ulcer in the squamous epithelium of the anus causing intense anal pain especially upon defecation and for one or two hours afterwards. There are no approved drugs in the US for this condition and surgery is often the treatment choice. Strakan is conducting this confirmatory study so the product can be submitted for regulatory approval in the US. Strakan currently markets this product throughout Europe.
To determine the effect of Cellegesic versus placebo on average pain intensity over every 24 hour period for up to 21 days of treatment in 250 patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized. Double-Blind, Placebo-Controlled, Multi-National Study to Determine the Effect of Cellegesic Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With a Chronic Anal Fissure|
- The effect of Cellegesic versus placebo on the absolute change in average pain intensity associated with a chronic anal fissure [ Time Frame: 3 weeks ]
|Study Start Date:||August 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Drug: nitroglycerin 0.4%
|Placebo Comparator: 2||