Efficacy Study of Iferanserin to Treat Hemorrhoids

Ventrus Biosciences

Status and phase

Completed

Phase 2

Conditions

Hemorrhoids

Treatments

Drug: Iferanserin

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01483833

VEN309-SMPEC-001

Details and patient eligibility

About

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.

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.