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Completed

NCT Number: NCT00522041

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

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.

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Key information

Conditions

Fissure in Ano Anus Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cellegesic

Drug

Cellegesic was supplied as an ointment containing 0.4% w/w nitroglycerin.

Other names: 0.4% nitroglycerin ointment, Rectogesic

Placebo

Drug

Placebo was supplied as an ointment identical to Cellegesic ointment except that it contained no nitroglycerin.

Primary outcomes

  1. Change From Baseline in Pain Intensity at Days 14-18

    Time frame: 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 outcomes

  1. Time to an Improvement in Pain Intensity

    Time frame: 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.

  2. Percentage of Responders

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 29, 2007
Registry last updated
Nov 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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