Fecal Incontinence, Spinal Cord Injury
Conditions
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.
Interventions
DRUGPlacebo gel
Placebo gel applied intra-anally once daily
DRUGOxymetazoline gel
Oxymetazoline gel applied intra-anally once daily
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 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine the effect of Oxymetazoline gel on fecal incontinence episodes in the 8 hours following application. | 4 weeks |
Secondary
| Measure | 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 |
Countries
Hungary
Outcome results
None listed