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

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.

Timeline

Start

2007-08

Primary completion

2008-07

Completion

2008-07

Outcome

Missed primary endpoint

paper The prespecified baseline observation carried forward (BOCF) analysis found no significant difference between groups PMID 23815124 ↗

Publications

• Berry SM, Barish CF, Bhandari R, Clark G, Collins GV, Howell J, Pappas JE, Riff DS, Safdi M, Yellowlees A. Nitroglycerin 0.4% ointment vs placebo in the treatment of pain resulting from chronic anal fissure: a randomized, double-blind, placebo-controlled study. BMC Gastroenterol. 2013 Jul 1;13:106. doi: 10.1186/1471-230X-13-106.

Drugs

Indications