Idiopathic Fecal Incontinence
Conditions
Keywords
Fecal Incontinence, Alpha agonist
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.
Detailed 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.
Interventions
DRUGalpha agonist ointment
2 weeks local treatment with alpha agonist ointment
DRUGPlacebo
2 weeks local treatment with placebo ointment
Sponsors
RDD Pharma Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal Incontinence | After 2 weeks of treatment | number of unwanted/unexpected bowel movements in the time period after use of alpha agonist ointment |
Countries
Israel
Outcome results
None listed