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 Details — Status: Completed

Administrative data

• NCT number: NCT00522041
• Other study ID #: REC-C-01
• Status: Completed
• Phase: Phase 3
• First received: August 28, 2007
• Last updated: May 6, 2009
• Start date: August 2007
• Est. completion date: July 2008

Study information

• Verified date: May 2009
• Source: Prostrakan Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

• Fissure in Ano
• Pain

Intervention

Drug:
• nitroglycerin 0.4%
ointment
• Placebo
ointment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prostrakan Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of Cellegesic versus placebo on the absolute change in average pain intensity associated with a chronic anal fissure		3 weeks