The Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients

Study Overview
=================
Brief Summary
-----------------
This is an double blinded, cross-over study to determine the effect of Oxymetazoline gel on anal resting pressure and fecal incontinence in patients with spinal cord injury. Approximately 17 subjects are expected to complete this 10 weeks study that will include two treatment periods of 4 weeks each, and one 2 weeks wash out period.

Official Title
-----------------
A Double Blind Study to Examine the Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients

Conditions
-----------------
Fecal Incontinence, Spinal Cord Injury

Intervention / Treatment
-----------------
* Drug: Oxymetazoline gel
* Drug: Placebo gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent. Male or female subjects 18 to 55 years of age; Spinal Cord Injury that occurred at least 3 months from randomization day and less than 3 years from randomization day. At least 4 unwanted/unexpected incontinent events/week Exclusion Criteria: Known allergy to Oxymetazoline or silicone. Pregnancy or lactation. Active 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; History of rectal surgery. History of HIV, hepatitis B, hepatitis C. Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula, infection or space occupying lesion. Has used, in the last 1 week, drugs that may affect blood coagulation, such as Aspirin (at a dose above 500 mg/day), Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine. Hypertension (blood pressure over 150/105 mm Hg in screening visit) Unable to understand the use instruction, as judged by the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Intra-anal Oxymetazoline gel once daily | Drug: Oxymetazoline gel<br>* Oxymetazoline gel applied intra-anally once daily<br>|
| Placebo Comparator: Placebo<br>Intra-anal Placebo gel once daily | Drug: Placebo gel<br>* Placebo gel applied intra-anally once daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the effect of Oxymetazoline gel on fecal incontinence episodes in the 8 hours following application. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (area under the curve [AUC]), peak concentration and half life time (T 1/2) of Oxymetazoline; |  | 4 weeks | 
| Number of participants with adverse events |  | 4 weeks |