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

Idiopathic Fecal Incontinence Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01421823
• Other study ID #: RDD 111
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: August 21, 2011
• Last updated: December 11, 2013
• Start date: August 2011

Study information

• Verified date: December 2013
• Source: RDD Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence
• Idiopathic Fecal Incontinence

Intervention

Drug:
• alpha agonist ointment
2 weeks local treatment with alpha agonist ointment
• Placebo
2 weeks local treatment with placebo ointment

Locations

Country	Name	City	State
Israel	Proctology Clinic, Asaf Harofe Medical Center	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
RDD Pharma Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal Incontinence	number of unwanted/unexpected bowel movements in the time period after use of alpha agonist ointment	After 2 weeks of treatment	No