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

R

RDD Pharma

Status and phase

Withdrawn
Phase 2

Conditions

Fecal Incontinenece

Treatments

Drug: caoted suppository
Drug: coated suppository

Study type

Interventional

Funder types

Industry

Identifiers

NCT01297608
RDD 106

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 55 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

0 participants in 2 patient groups, including a placebo group

treatment
Experimental group
Treatment:
Drug: coated suppository
Drug: caoted suppository
placebo
Placebo Comparator group
Treatment:
Drug: coated suppository

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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