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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RDD Pharma Ltd

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.