NCT00522041

A Study to Determine the Effect of Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With Chronic Anal Fissures

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Anal fissure is a solitary ulcer in the squamous epithelium of the anus causing intense anal pain especially during defecation and for 1 or 2 hours afterwards. There are no approved drugs in the United States (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. The objective of this study is to determine the effect of nitroglycerin ointment 0.4% (Cellegesic) versus placebo on average pain intensity over every 24 hour period for up to 21 days of treatment in 250 patients.

Conditions

• Fissure in Ano
• Pain

Interventions

Type	Name	Description
DRUG	Cellegesic	Cellegesic was supplied as an ointment containing 0.4% w/w nitroglycerin.
DRUG	Placebo	Placebo was supplied as an ointment identical to Cellegesic ointment except that it contained no nitroglycerin.

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2007-08-29
• Last updated: 2016-11-03
• Results posted: 2016-11-03