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

NCT ID: NCT01297608

Last Updated: 2013-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-09-30

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.

Detailed Description

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Conditions

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Fecal Incontinenece

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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treatment

Group Type EXPERIMENTAL

caoted suppository

Intervention Type DRUG

coated suppository with active drug

coated suppository

Intervention Type DRUG

coated suppository with placebo

placebo

Group Type PLACEBO_COMPARATOR

coated suppository

Intervention Type DRUG

coated suppository with placebo

Interventions

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caoted suppository

coated suppository with active drug

Intervention Type DRUG

coated suppository

coated suppository with placebo

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RDD Pharma Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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RDD Pharma

Locations

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Gastroeneterology dept, Asaf harofe Medical center

Zrifin, , Israel

Site Status

Countries

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Israel

Other Identifiers

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RDD 106

Identifier Type: -

Identifier Source: org_study_id