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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Nitroglycerin

Criteria

Inclusion Criteria:

• Consenting patients of either sex.

• Between 18 and 75 years of age.

• With a single, chronic, posterior midline anal fissure.

• Defined as having anal pain for the 6 weeks prior to Screening.

Exclusion Criteria:

• More than one anal fissure.

• A fistula-in-ano or anal abscess.

• Inflammatory bowel disease.

• Fibrotic anal stenosis.

• Anal fissure secondary to an underlying condition.

• Any anal surgery.

• Concomitant medication that may interfere with study evaluation.