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

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Fissure in Ano; Pain

Treatments: Drug: Placebo; Drug: Cellegesic

Study type: Interventional

Funder types: Industry

Identifiers

NCT00522041

REC-C-01

Details and patient eligibility

About

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.

Enrollment: 248 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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248 participants in 2 patient groups, including a placebo group

Cellegesic (nitroglycerin 0.4%)

Experimental group

Description:

Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.

Treatment:

Drug: Cellegesic

Placebo 375 mg

Placebo Comparator group

Description:

Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.

Treatment:

Drug: Placebo