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

Study Overview
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Brief Summary
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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
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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
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Idiopathic Fecal Incontinence

Intervention / Treatment
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* Drug: alpha agonist ointment
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: alpha agonist ointment<br> | Drug: alpha agonist ointment<br>* 2 weeks local treatment with alpha agonist ointment<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 2 weeks local treatment with placebo ointment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal Incontinence | number of unwanted/unexpected bowel movements in the time period after use of alpha agonist ointment | After 2 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal Incontinence, Alpha agonist