A Double Blinded Study to Examine the Effect of Alpha Agonist Ointment on Fecal Incontinence in Patients With Idiopathic Fecal Incontinence

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
RDD Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01421823
First received: August 21, 2011
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to assess the effect and safety of alpha agonist ointment on fecal incontinence severity in patients with idiopathic fecal incontinence.


Condition Intervention Phase
Idiopathic Fecal Incontinence
Drug: alpha agonist ointment
Drug: Placebo
Phase 1
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: After 2 weeks of treatment ] [ Designated as safety issue: No ]
    number of unwanted/unexpected bowel movements in the time period after use of alpha agonist ointment


Enrollment: 0
Study Start Date: August 2011
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alpha agonist ointment Drug: alpha agonist ointment
2 weeks local treatment with alpha agonist ointment
Placebo Comparator: Placebo Drug: Placebo
2 weeks local treatment with placebo ointment

Detailed Description:

This is a double blinded cross over study. Approximately 40 subjects will be participating in this 4 weeks study. A screening visit will be used to determine eligibility for the study. Patients found eligible will receive alpha agonist ointment or placebo ointment for 2 weeks. This will be followed by a second 2 weeks treatment cycle in which:

  • patients previously treated with alpha agonist will be treated with placebo.
  • patients previously treated with placebo will be treated with alpha agonist.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent.
  • Male or female subjects 18 to 65 years of age.
  • Fecal incontinence score over 8.
  • The patient is able to understand the treatment and is willing to comply with the prescribed regimen.

Exclusion Criteria:

- Has a clinically significant history or presence of any of the following conditions:

  • Known allergy to the API.
  • Porphyria.
  • 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 over 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 inhibitors.
  • 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 ointment, 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: NCT01421823

Locations
Israel
Proctology Clinic, Asaf Harofe Medical Center
Zrifin, Israel, 70300
Sponsors and Collaborators
RDD Pharma Ltd
Investigators
Principal Investigator: Yehiel Ziv, MD RDD Pharma Ltd
  More Information

No publications provided

Responsible Party: RDD Pharma Ltd
ClinicalTrials.gov Identifier: NCT01421823     History of Changes
Other Study ID Numbers: RDD 111
Study First Received: August 21, 2011
Last Updated: December 11, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by RDD Pharma Ltd:
Fecal Incontinence
Alpha agonist

Additional relevant MeSH terms:
Fecal Incontinence
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014