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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
History of Changes

August 28, 2007
May 6, 2009
August 2007
July 2008   (final data collection date for primary outcome measure)
The effect of Cellegesic versus placebo on the absolute change in average pain intensity associated with a chronic anal fissure [ Time Frame: 3 weeks ]
Same as current
Complete list of historical versions of study NCT00522041 on ClinicalTrials.gov Archive Site
Not Provided
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A Study to Determine the Effect of Nitroglycerin Ointment on the Pain Associated With Chronic Anal Fissures
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Fissure in Ano
  • Pain
  • Drug: nitroglycerin 0.4%
    ointment
  • Drug: Placebo
    ointment
  • Experimental: 1
    Intervention: Drug: nitroglycerin 0.4%
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
247
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00522041
REC-C-01
No
Not Provided
Prostrakan Pharmaceuticals
Not Provided
Study Director: Gemma Clark Strakan Pharmaceuticals, Inc.
Prostrakan Pharmaceuticals
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP