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Sponsored by: |
Prostrakan Pharmaceuticals |
---|---|
Information provided by: | Prostrakan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00522041 |
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 |
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 |
Estimated Enrollment: | 250 |
Study Start Date: | August 2007 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: nitroglycerin 0.4%
ointment
|
2: Placebo Comparator |
Drug: Placebo
ointment
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mark Hendricks | 858.638.2538 |
United States, California | |
PPDI | Recruiting |
San Diego, California, United States, 18392 | |
Contact: Mark Hendricks 858-638-2538 |
Study Director: | Gemma Clark | Strakan Pharmaceuticals, Inc. |
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 |
Pain associated with chronic anal fissure |
Nitroglycerin Fissure in Ano Digestive System Diseases Gastrointestinal Diseases |
Pain Intestinal Diseases Rectal Diseases |
Vasodilator Agents Therapeutic Uses Cardiovascular Agents Anus Diseases Pharmacologic Actions |