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

Phase 1

Withdrawn

• Conditions: Idiopathic Fecal Incontinence
• Interventions: Drug: alpha agonist ointment; Drug: Placebo

• Registration Number: NCT01421823
• Lead Sponsor: RDD Pharma Ltd

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-21
• Study First Submitted QC: 2011-08-22
• Study First Posted: 2011-08-23
• Primary Completion: 2012-04
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
alpha agonist ointment	alpha agonist ointment	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Fecal Incontinence	After 2 weeks of treatment	number of unwanted/unexpected bowel movements in the time period after use of alpha agonist ointment

Trial Locations

Locations (1)

Proctology Clinic, Asaf Harofe Medical Center; 🇮🇱 Zrifin, Israel