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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
RDD Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01297608
First received: February 15, 2011
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Fecal Incontinenece
Drug: caoted suppository
Drug: coated suppository
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by RDD Pharma Ltd:

Primary Outcome Measures:
  • fecal incontinence [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2011
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment Drug: caoted suppository
coated suppository with active drug
Drug: coated suppository
coated suppository with placebo
Placebo Comparator: placebo Drug: coated suppository
coated suppository with placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297608

Locations
Israel
Gastroeneterology dept, Asaf harofe Medical center
Zrifin, Israel
Sponsors and Collaborators
RDD Pharma Ltd
  More Information

No publications provided

Responsible Party: Nir Barak, RDD Pharma
ClinicalTrials.gov Identifier: NCT01297608     History of Changes
Other Study ID Numbers: RDD 106
Study First Received: February 15, 2011
Last Updated: December 11, 2013
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Fecal Incontinence
Spinal Cord Injuries
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on August 21, 2014