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

This is an interventional treatment trial for Idiopathic Fecal Incontinence focused on measuring Fecal Incontinence, Alpha agonist Read More

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.