Efficacy Study of Iferanserin to Treat Hemorrhoids

Protocol for the Study of the Effects of S-MPEC (Iferanserin) in Patients With Hemorrhoids

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.

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.