Conditions: Fissure in Ano Pain
Keywords: Pain associated with chronic anal fissure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 248
Healthy volunteers: no

Brief summary:
Anal fissure is a solitary ulcer in the squamous epithelium of the anus causing intense anal pain especially during defecation and for 1 or 2 hours afterwards. There are no approved drugs in the United States (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.

The objective of this study is to determine the effect of nitroglycerin ointment 0.4% (Cellegesic) versus placebo on average pain intensity over every 24 hour period for up to 21 days of treatment in 250 patients.

Detailed description:

Arms:
arm 1: Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days. arm 2: Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.

Interventions: intervention 1: Cellegesic intervention 2: Placebo
Intervention descriptions: intervention 1: Cellegesic was supplied as an ointment containing 0.4% w/w nitroglycerin. intervention 2: Placebo was supplied as an ointment identical to Cellegesic ointment except that it contained no nitroglycerin.

Protocol document: