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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This study has been withdrawn prior to enrollment.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:
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

August 21, 2011
December 11, 2013
August 2011
April 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01421823 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Double Blinded Study to Examine the Effect of Alpha Agonist Ointment on Fecal Incontinence in Patients With Idiopathic Fecal Incontinence
Not Provided

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.

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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Idiopathic Fecal Incontinence
  • Drug: alpha agonist ointment
    2 weeks local treatment with alpha agonist ointment
  • Drug: Placebo
    2 weeks local treatment with placebo ointment
  • Experimental: alpha agonist ointment
    Intervention: Drug: alpha agonist ointment
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
April 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01421823
RDD 111
No
RDD Pharma Ltd
RDD Pharma Ltd
Not Provided
Principal Investigator: Yehiel Ziv, MD RDD Pharma Ltd
RDD Pharma Ltd
December 2013

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