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This is a double blinded cross over study. Approximately 20 spinal cord injury patients will be participating in this 4 weeks study.The primary outcome is difference in fecal incontinence as recorded in diaries, between the treatment period and the treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| caoted suppository | Drug | coated suppository with active drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| fecal incontinence | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | 2 weeks |
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Inclusion Criteria:
Signed written informed consent; Male or female subjects 18 to 55 years of age; Spinal cord lesion/disease/injury at any level at least 3 months from injury. FISI (Fecal Incontinence Severity Index) > 8 units. The patient is able to understand the treatment and is willing to comply with the prescribed regimen
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroeneterology dept, Asaf harofe Medical center | Zrifin | Israel |
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| coated suppository |
| Drug |
coated suppository with placebo |
|