MedDataX Logo

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

NCT ID: NCT00522041

Last Updated: 2016-11-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fissure in Ano Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pain associated with chronic anal fissure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cellegesic (nitroglycerin 0.4%)

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.

Group Type EXPERIMENTAL

Cellegesic

Intervention Type DRUG

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

Placebo 375 mg

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cellegesic

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

0.4% nitroglycerin ointment Rectogesic

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gemma Clark

Role: STUDY_DIRECTOR

Strakan Pharmaceuticals, Inc.

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Berry SM, Barish CF, Bhandari R, Clark G, Collins GV, Howell J, Pappas JE, Riff DS, Safdi M, Yellowlees A. Nitroglycerin 0.4% ointment vs placebo in the treatment of pain resulting from chronic anal fissure: a randomized, double-blind, placebo-controlled study. BMC Gastroenterol. 2013 Jul 1;13:106. doi: 10.1186/1471-230X-13-106.

Reference Type DERIVED
PMID: 23815124 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC-C-01

Identifier Type: -

Identifier Source: org_study_id