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

Phase 2

Withdrawn

• Conditions: Fecal Incontinenece
• Interventions: Drug: caoted suppository; Drug: coated suppository

• Registration Number: NCT01297608
• Lead Sponsor: RDD Pharma Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-15
• Study First Submitted QC: 2011-02-15
• Study First Posted: 2011-02-17
• Study Start: 2011-04
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
treatment	caoted suppository	-
treatment	coated suppository	-
placebo	coated suppository	-

Primary Outcome Measures

Name	Time	Method
fecal incontinence	2 weeks

Secondary Outcome Measures

Name	Time	Method
quality of life	2 weeks

Trial Locations

Locations (1)

Gastroeneterology dept, Asaf harofe Medical center; 🇮🇱 Zrifin, Israel