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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01421823
Recruitment Status : Withdrawn
First Posted : August 23, 2011
Last Update Posted : December 12, 2013
Information provided by (Responsible Party):
RDD Pharma Ltd

Brief Summary:
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 or disease Intervention/treatment Phase
Idiopathic Fecal Incontinence Drug: alpha agonist ointment Drug: Placebo Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2011
Estimated Primary Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Fecal Incontinence [ Time Frame: After 2 weeks of treatment ]
    number of unwanted/unexpected bowel movements in the time period after use of alpha agonist ointment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01421823

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

Responsible Party: RDD Pharma Ltd Identifier: NCT01421823     History of Changes
Other Study ID Numbers: RDD 111
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013

Keywords provided by RDD Pharma Ltd:
Fecal Incontinence
Alpha agonist

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