Pain Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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