Status:
WITHDRAWN
A Double Blinded Study to Examine the Effect of Alpha Agonist Ointment on Fecal Incontinence in Patients With Idiopathic Fecal Incontinence
Lead Sponsor:
RDD Pharma Ltd
Conditions:
Idiopathic Fecal Incontinence
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01421823
Start Date
August 1 2011
Last Update
December 12 2013
Active Locations (1)
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1
Proctology Clinic, Asaf Harofe Medical Center
Zrifin, Israel, 70300