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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alpha agonist ointment | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alpha agonist ointment | Drug | 2 weeks local treatment with alpha agonist ointment |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Has a clinically significant history or presence of any of the following conditions:
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| Name | Affiliation | Role |
|---|---|---|
| Yehiel Ziv, MD | RDD Pharma Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Proctology Clinic, Asaf Harofe Medical Center | Zrifin | 70300 | Israel |
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| Placebo |
| Drug |
2 weeks local treatment with placebo ointment |
|
| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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