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

Phase 3

Completed

• Conditions: Fissure in Ano; Pain
• Interventions: Drug: Placebo; Drug: Cellegesic

• Registration Number: NCT00522041
• Lead Sponsor: Forest Laboratories

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-28
• Study First Submitted QC: 2007-08-28
• Study First Posted: 2007-08-29
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2014-01-27
• Status Verified: 2016-09
• Results First Submitted QC: 2016-09-15
• Last Update Submitted: 2016-09-15
• Results First Posted: 2016-11-03
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo 375 mg	Placebo	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.
Cellegesic (nitroglycerin 0.4%)	Cellegesic	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Pain Intensity at Days 14-18	Baseline to Day 18	Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale at Baseline and on Days 14 through 18. The average pain rating on Days 14 through 18 was calculated and used to determine the change from Baseline. The left-end of the visual analog scale was labelled "least possible pain" and the right-end of the visual analog scale was labelled "worst possible pain". The pain rating ranged from 0 to 100, with a higher score indicating more pain. A negative change score indicated improvement.

Secondary Outcome Measures

Name	Time	Method
Time to an Improvement in Pain Intensity	Baseline to Day 21	Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale (VAS) at Baseline and on each of the 21 treatment days of the study. The left-end of the visual analog scale was labelled "least possible pain" and the right-end of the visual analog scale was labelled "worst possible pain". The pain rating ranged from 0 to 100, with a higher score indicating more pain. Improvement was defined as either a ≥ 50% decrease or a ≥ 10 mm decrease from Baseline in rated pain intensity.
Percentage of Responders	Baseline to Day 18	Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale at Baseline and on Days 14 through 18. The average pain rating on Days 14 through 18 was calculated. The left-end of the visual analog scale was labelled "least possible pain" and the right-end of the visual analog scale was labelled "worst possible pain". The pain rating ranged from 0 to 100, with a higher score indicating more pain. A responder was defined as a participant with either a ≥ 50% decrease or a ≥ 10 mm decrease from Baseline in the 24 hour average pain intensity averaged over Days 14 to 18.