A Double Blinded Study to Examine the Effect of Coated Suppositories on Fecal Incontinence in Patients With Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Conditions
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Fecal Incontinenece

Intervention / Treatment
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* Drug: caoted suppository
* Drug: coated suppository


Participation Criteria
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Eligibility Criteria
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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: Known allergy to experimental drug.. Porphiria. 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 > 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 inhibors. 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 coated suppository, as judged by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br> | Drug: caoted suppository<br>* coated suppository with active drug<br>Drug: coated suppository<br>* coated suppository with placebo<br>|
| Placebo Comparator: placebo<br> | Drug: coated suppository<br>* coated suppository with placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fecal incontinence |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | 2 weeks |