NCT02299557

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: RDD Pharma Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fecal Incontinence
• Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	Oxymetazoline gel	Oxymetazoline gel applied intra-anally once daily
DRUG	Placebo gel	Placebo gel applied intra-anally once daily

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-06-01
• Completion: 2015-07-01
• First posted: 2014-11-24
• Last updated: 2015-07-28

Locations

1 site across 1 country: Hungary