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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
19
Oxymetazoline gel applied intra-anally once daily
Placebo gel applied intra-anally once daily
Semmelweis Egyetem I. sz. Belgyógyászati Klinika
Budapest, Hungary
To examine the effect of Oxymetazoline gel on fecal incontinence episodes in the 8 hours following application.
Time frame: 4 weeks
Pharmacokinetics (area under the curve [AUC]), peak concentration and half life time (T 1/2) of Oxymetazoline;
Time frame: 4 weeks
Number of participants with adverse events
Time frame: 4 weeks
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