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

This study has been completed.
Sponsor:
Information provided by:
Prostrakan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00522041
First received: August 28, 2007
Last updated: May 6, 2009
Last verified: May 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 247
Study Start Date: August 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: nitroglycerin 0.4%
ointment
Placebo Comparator: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Prostrakan Pharmaceuticals
Investigators
Study Director: Gemma Clark Strakan Pharmaceuticals, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00522041     History of Changes
Other Study ID Numbers: REC-C-01
Study First Received: August 28, 2007
Last Updated: May 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Prostrakan Pharmaceuticals:
Pain associated with chronic anal fissure

Additional relevant MeSH terms:
Fissure in Ano
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nitroglycerin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014