Efficacy Study of Iferanserin to Treat Hemorrhoids

• Status: Completed
• Trial end date: 2002-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy of topical 0.5% S-MPEC cream vs. placebo cream (applied twice daily for 14 days) in the treatment of Grade I - III hemorrhoids.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ventrus Biosciences, Inc

Criteria

Inclusion Criteria:

• Age 18 years or older

• Diagnosis of grade I - III hemorrhoids with bleeding episodes of at least every other day during the last two weeks before enrollment in the study.

• Patients signing the Informed Consent form.

Exclusion Criteria:

• Patients with protruding or irreducible hemorrhoids (grade IV).

• Patients with anal fistulas, periproctitis or hemorrhagic diathesis

• Patients with current history of Type I or Type II diabetes mellitus.

• Patients with severe hepatic, renal or cardiovascular disorders.

• Patients with any type of infectious disease.

• Patients who have been involved with another experimental drug trial within the past 30 days.

• Patients presently diagnosed with cancer.

• Patients who have known alcohol and drug abuse.

• Patients who require the use of suppositories.

• Patients with blood or urine laboratory values outside the normal limits or those with values considered abnormal in the opinion of the investigator.