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

NCT01421823 | Withdrawn Phase 1

• 1 other identifier: RDD 111
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Fecal Incontinence

Keywords

Fecal Incontinence; Alpha agonist

Outcome Measures

Primary Outcomes (1)

• Fecal Incontinence

  number of unwanted/unexpected bowel movements in the time period after use of alpha agonist ointment

  After 2 weeks of treatment

Study Arms (2)

alpha agonist ointment

EXPERIMENTAL

Drug: alpha agonist ointment

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

alpha agonist ointment DRUG

2 weeks local treatment with alpha agonist ointment

alpha agonist ointment

Placebo DRUG

2 weeks local treatment with placebo ointment

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• RDD Pharma Ltd: lead

Study Sites (1)

Proctology Clinic, Asaf Harofe Medical Center

Zrifin, 70300, Israel

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Yehiel Ziv, MD

  RDD Pharma Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2011
• First Posted: August 23, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2012
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

IL (1)