A Study to Determine the Effect of Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With Chronic Anal Fissures
CompletedPhase 3NCT00522041
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Fissure in Ano
- Pain
- Interventions
- Drug: Cellegesic
- Drug: Placebo
- Sponsor
- Forest Laboratories
- Start date
- 2007-08
- Primary completion
- 2008-07
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00522041