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

RDD Pharma

Status and phase

Completed

Phase 2

Phase 1

Conditions

Fecal Incontinence

Spinal Cord Injury

Treatments

Drug: Placebo gel

Drug: Oxymetazoline gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT02299557

RDD 116

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.