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A Study to Determine the Effect of Nitroglycerin Ointment on the Pain Associated With Chronic Anal Fissures

Pain Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00522041
Study type Interventional
Source Prostrakan Pharmaceuticals
Contact
Status Completed
Phase Phase 3
Start date August 2007
Completion date July 2008
View Details
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