A Double Blinded Study to Examine the Effect of Alpha Agonist Ointment on Fecal Incontinence in Patients With Idiopathic Fecal Incontinence
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: alpha agonist ointment
|
Drug: alpha agonist ointment
2 weeks local treatment with alpha agonist ointment
|
| Placebo Comparator: Placebo
|
Drug: Placebo
2 weeks local treatment with placebo ointment
|
Outcome Measures
Primary Outcome Measures
- Fecal Incontinence [After 2 weeks of treatment]
number of unwanted/unexpected bowel movements in the time period after use of alpha agonist ointment
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed written informed consent.
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Male or female subjects 18 to 65 years of age.
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Fecal incontinence score over 8.
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The patient is able to understand the treatment and is willing to comply with the prescribed regimen.
Exclusion Criteria:
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Has a clinically significant history or presence of any of the following conditions:
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Known allergy to the API.
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Porphyria.
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Glaucoma.
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Pregnancy or lactation.
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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;
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Type 1 diabetes mellitus;
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Insulin treated type 2 diabetes mellitus.
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Renal insufficiency.
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Liver insufficiency.
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Malignant disease within 5 years of screening;
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Has hypertension (sitting blood pressure over 140/90 mmHg at screening)
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History of rectal surgery.
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History of HIV, hepatitis B, hepatitis.
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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.
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Use of tricyclic or monoamine-oxidase inhibitors.
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Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula., infection or space occupying lesion.
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Unable to understand the use instruction for the ointment, as judged by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Proctology Clinic, Asaf Harofe Medical Center | Zrifin | Israel | 70300 |
Sponsors and Collaborators
- RDD Pharma Ltd
Investigators
- Principal Investigator: Yehiel Ziv, MD, RDD Pharma Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RDD 111