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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01297608

Enrollment

Registered

2011-02-17

Start date

2011-04-30

Completion date

2011-09-30

Last updated

2013-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fecal Incontinenece

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.

Interventions

DRUGcaoted suppository

coated suppository with active drug

DRUGcoated suppository

coated suppository with placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
fecal incontinence	2 weeks

Secondary

Measure	Time frame
quality of life	2 weeks

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026