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

RDD Pharma Ltd1 site in 1 countryApril 2011

ConditionsFecal Incontinenece

Interventionscaoted suppository coated suppository

Drugscaoted suppository coated suppository

Overview

Phase: Phase 2
Intervention: caoted suppository
Conditions: Fecal Incontinenece
Sponsor: RDD Pharma Ltd
Locations: 1
Primary Endpoint: fecal incontinence
Status: Withdrawn
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

September 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

RDD Pharma Ltd

Eligibility Criteria

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;