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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by RDD Pharma Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
RDD Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01297608
First received: February 15, 2011
Last updated: April 5, 2011
Last verified: April 2011
History of Changes

February 15, 2011
April 5, 2011
April 2011
August 2011   (final data collection date for primary outcome measure)
fecal incontinence [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01297608 on ClinicalTrials.gov Archive Site
quality of life [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Double Blinded Study to Examine the Effect of Coated Suppositories on Fecal Incontinence in Patients With Spinal Cord Injury
Not Provided

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fecal Incontinenece
  • Drug: caoted suppository
    coated suppository with active drug
  • Drug: coated suppository
    coated suppository with placebo
  • Experimental: treatment
    Interventions:
    • Drug: caoted suppository
    • Drug: coated suppository
  • Placebo Comparator: placebo
    Intervention: Drug: coated suppository
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
September 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact: Margarita Zalmanovitz margaritaz@asaf.health.gov.il
Israel
 
NCT01297608
RDD 106
No
Nir Barak, RDD Pharma
RDD Pharma Ltd
Not Provided
Not Provided
RDD Pharma Ltd
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP