A Double Blinded Study to Examine the Effect of Alpha Agonist Ointment on Fecal Incontinence in Patients With Idiopathic Fecal Incontinence

NCT ID: NCT01421823

Last Updated: 2013-12-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31

Brief Summary

The purpose of this study is to assess the effect and safety of alpha agonist ointment on fecal incontinence severity in patients with idiopathic fecal incontinence.

Detailed Description

This is a double blinded cross over study. Approximately 40 subjects will be participating in this 4 weeks study. A screening visit will be used to determine eligibility for the study. Patients found eligible will receive alpha agonist ointment or placebo ointment for 2 weeks. This will be followed by a second 2 weeks treatment cycle in which:

• patients previously treated with alpha agonist will be treated with placebo.
• patients previously treated with placebo will be treated with alpha agonist.

Conditions

Idiopathic Fecal Incontinence

Keywords

Fecal Incontinence; Alpha agonist

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

alpha agonist ointment

Group Type: EXPERIMENTAL

alpha agonist ointment

Intervention Type: DRUG

2 weeks local treatment with alpha agonist ointment

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

2 weeks local treatment with placebo ointment

Interventions

alpha agonist ointment

2 weeks local treatment with alpha agonist ointment

Intervention Type: DRUG

Placebo

2 weeks local treatment with placebo ointment

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed written informed consent.
• Male or female subjects 18 to 65 years of age.
• Fecal incontinence score over 8.
• The patient is able to understand the treatment and is willing to comply with the prescribed regimen.

Exclusion Criteria

• Has a clinically significant history or presence of any of the following conditions:

• Known allergy to the API.
• Porphyria.
• Glaucoma.
• Pregnancy or lactation.
• Active or past history of cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
• Type 1 diabetes mellitus;
• Insulin treated type 2 diabetes mellitus.
• Renal insufficiency.
• Liver insufficiency.
• Malignant disease within 5 years of screening;
• Has hypertension (sitting blood pressure over 140/90 mmHg at screening)
• History of rectal surgery.
• History of HIV, hepatitis B, hepatitis.
• Has used, in the last four weeks, drugs that may affect blood coagulation, such as Aspirin (at a dose above 250 mg/day), Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
• Use of tricyclic or monoamine-oxidase inhibitors.
• Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula., infection or space occupying lesion.
• Unable to understand the use instruction for the ointment, as judged by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RDD Pharma Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yehiel Ziv, MD

Role: PRINCIPAL_INVESTIGATOR

RDD Pharma Ltd

Locations

Proctology Clinic, Asaf Harofe Medical Center

Zrifin, , Israel

Countries

Israel

Other Identifiers

RDD 111

Identifier Type: -

Identifier Source: org_study_id