Status:
COMPLETED
Efficacy Study of Iferanserin to Treat Hemorrhoids
Lead Sponsor:
Ventrus Biosciences, Inc
Conditions:
Hemorrhoids
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2002
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01483833
Start Date
September 1 2001
End Date
August 1 2002
Last Update
August 21 2013
Active Locations (1)
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1
Prof. Alexander Herold, MD
Mannheim, Germany