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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT01421823
First Posted: August 23, 2011
Last Update Posted: December 12, 2013
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.
Information provided by (Responsible Party):
RDD Pharma Ltd
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: RDD Pharma Ltd
ClinicalTrials.gov Identifier: NCT01421823     History of Changes
Other Study ID Numbers: RDD 111
First Submitted: August 21, 2011
First Posted: August 23, 2011
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