Cellegy Presents Interim Results of Rectogesic Hemorrhoid Trial

Cellegy Pharmaceuticals has reported interim results of a two-center study of Rectogesic, nitroglycerin (glyceryl trinitrate) ointment 0.2 percent, for the treatment of symptomatic chronic hemorrhoids.

Symptomatic chronic hemorrhoids are common, but there are no satisfactory topical treatments. Increased anal sphincter pressure is frequently associated with symptomatic chronic hemorrhoids. Forty-seven patients with first and second-degree symptomatic chronic hemorrhoids and above-normal anal sphincter pressure were included in the study. Anal sphincter pressure was measured before and 30 minutes after the first dose of topical Rectogesic. Rectogesic was then to be used three times per day for two weeks followed by two weeks of observation. Patients used a daily diary for self-assessment of symptoms.

Mean anal sphincter pressure was significantly decreased 30 minutes after the first dose of topical Rectogesic. Patients had significant improvement in pain, bleeding, throbbing, itching, irritation and difficulty with bowel movement. Symptomatic improvement increased with time, even after the cessation of Rectogesic. Rectogesic was generally well-tolerated. Twenty-three patients had adverse events related to Rectogesic that occurred in the four-week study period: 19 headache, three dizziness and one vomiting. Four patients withdrew because of severe headache.