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

Information source: Prostrakan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fissure in Ano; Pain

Intervention: nitroglycerin 0.4% (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Prostrakan Pharmaceuticals

Official(s) and/or principal investigator(s):
Gemma Clark, Study Director, Affiliation: Strakan Pharmaceuticals, Inc.


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 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

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

Primary outcome: The effect of Cellegesic versus placebo on the absolute change in average pain intensity associated with a chronic anal fissure


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: August 2007
Last updated: May 6, 2009

Page last updated: August 23, 2015

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