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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02299557
• Date of registration: 17/11/2014
• Prospective Registration: No
• Primary sponsor: RDD Pharma Ltd
• Public title: The Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients
• Scientific title: A Double Blind Study to Examine the Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients
• Date of first enrolment: November 2014
• Target sample size: 19
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02299557
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Hungary

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Spinal Cord Injury

Fecal Incontinence

Intervention(s)

Drug: Oxymetazoline gel

Drug: Placebo gel

Primary Outcome(s)

To examine the effect of Oxymetazoline gel on fecal incontinence episodes in the 8 hours following application. [Time Frame: 4 weeks]

Secondary Outcome(s)

Number of participants with adverse events [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]

Secondary ID(s)

RDD 116

Source(s) of Monetary Support

Please refer to primary and secondary sponsors