- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01421823
A Double Blinded Study to Examine the Effect of Alpha Agonist Ointment on Fecal Incontinence in Patients With Idiopathic Fecal Incontinence
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
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Zrifin, Israel, 70300
- Proctology Clinic, Asaf Harofe Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
2 weeks local treatment with placebo ointment
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Experimental: alpha agonist ointment
|
2 weeks local treatment with alpha agonist ointment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fecal Incontinence
Time Frame: After 2 weeks of treatment
|
number of unwanted/unexpected bowel movements in the time period after use of alpha agonist ointment
|
After 2 weeks of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yehiel Ziv, MD, RDD Pharma Ltd
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RDD 111
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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