A Study to Determine the Effect of Nitroglycerin Ointment on the Pain Associated With Chronic Anal Fissures

This study is currently recruiting participants.

Verified by Prostrakan Pharmaceuticals, August 2007

Sponsored by:	Prostrakan Pharmaceuticals
Information provided by:	Prostrakan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00522041

Purpose

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.

Condition	Intervention	Phase
Fissure in Ano Pain	Drug: nitroglycerin 0.4% Drug: Placebo	Phase III

Drug Information available for: Nitroglycerin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Prostrakan Pharmaceuticals:

Primary Outcome Measures:

The effect of Cellegesic versus placebo on the absolute change in average pain intensity associated with a chronic anal fissure [ Time Frame: 3 weeks ]

Estimated Enrollment:	250
Study Start Date:	August 2007

Arms	Assigned Interventions
1: Experimental	Drug: nitroglycerin 0.4% ointment
2: Placebo Comparator	Drug: Placebo ointment

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522041

Contacts

Contact: Mark Hendricks

858.638.2538

Locations

United States, California
PPDI	Recruiting
San Diego, California, United States, 18392
Contact: Mark Hendricks 858-638-2538

Sponsors and Collaborators

Prostrakan Pharmaceuticals

Investigators

Study Director:

Gemma Clark

Strakan Pharmaceuticals, Inc.

More Information

Click here for more information about this trial: A Study to Determine the Effect of Nitroglycerin Ointment on the Pain Associated With Chronic Anal Fissures This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Study ID Numbers:	REC-C-01
Study First Received:	August 28, 2007
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00522041
Health Authority:	United States: Food and Drug Administration

Keywords provided by Prostrakan Pharmaceuticals:

Pain associated with chronic anal fissure

Study placed in the following topic categories:

Nitroglycerin
Fissure in Ano
Digestive System Diseases
Gastrointestinal Diseases

Pain
Intestinal Diseases
Rectal Diseases

Additional relevant MeSH terms:

Vasodilator Agents
Therapeutic Uses
Cardiovascular Agents
Anus Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009