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

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.

Study Overview

• Status: Withdrawn
• Conditions: Fecal Incontinenece
• Intervention / Treatment: Drug: caoted suppository; Drug: coated suppository

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Zrifin, Israel
    • Gastroeneterology dept, Asaf harofe Medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: coated suppository; coated suppository with placebo
Experimental: treatment	Drug: caoted suppository; coated suppository with active drug; Drug: coated suppository; coated suppository with placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
fecal incontinence	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
quality of life	2 weeks

Collaborators and Investigators

• Sponsor: RDD Pharma Ltd

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): August 1, 2011
• Study Completion (Anticipated): September 1, 2011

Study Registration Dates

• First Submitted: February 15, 2011
• First Submitted That Met QC Criteria: February 15, 2011
• First Posted (Estimate): February 17, 2011

Study Record Updates

• Last Update Posted (Estimate): December 12, 2013
• Last Update Submitted That Met QC Criteria: December 11, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: RDD 106