Fecal Incontinenece Clinical Trial
| Verified date | December 2013 |
| Source | RDD Pharma Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ethics Commission |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | September 2011 |
| Est. primary completion date | August 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 55 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Gastroeneterology dept, Asaf harofe Medical center | Zrifin |
| Lead Sponsor | Collaborator |
|---|---|
| RDD Pharma Ltd |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | fecal incontinence | 2 weeks | No | |
| Secondary | quality of life | 2 weeks | No |