A Study to Determine the Effect of Nitroglycerin Ointment on the Pain Associated With Chronic Anal Fissures
Information source: Prostrakan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fissure in Ano; Pain
Intervention: nitroglycerin 0.4% (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Prostrakan Pharmaceuticals Official(s) and/or principal investigator(s):
Gemma Clark, Study Director, Affiliation: Strakan Pharmaceuticals, Inc.
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The effect of Cellegesic versus placebo on the absolute change in average pain intensity associated with a chronic anal fissure
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: August 2007
Last updated: May 6, 2009
|
