Efficacy Study of Iferanserin to Treat Hemorrhoids

Hemorrhoids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483833
• Other study ID #: VEN309-SMPEC-001
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2011
• Last updated: August 19, 2013
• Start date: September 2001
• Est. completion date: August 2002

Study information

• Verified date: November 2011
• Source: Ventrus Biosciences, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: August 2002
• Est. primary completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Drug:
• Iferanserin
Iferanserin 0.5% ointment applied intra-anally twice daily for 14 days
• Placebo
Placebo ointment applied intra-anally twice daily for 14 days

Locations

Country	Name	City	State
Germany	Prof. Alexander Herold, MD	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Ventrus Biosciences, Inc

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of hemorrhoid bleeding	Change from pre-treatment in patient assessment of hemorrhoid bleeding (10-point scale: 1=Not at all, 10=Extremely) at the end of one- and two-weeks of treatment are the primary efficacy endpoints for the study.	Day 7 and 14	No
Secondary	Assessment of bleeding, hemorrhoid size, other hemorrhoid symptoms, and physician evaluation of hemorrhoids.	Change from pre-treatment in patient assessment of bleeding on other treatment days, change from pre-treatment in hemorrhoid size, change from pre-treatment in patient assessment of other hemorrhoid symptoms/conditions on all treatment days, and physician evaluation of hemorrhoids at the end of treatment.	14 days	No