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

NCT ID: NCT02299557

Last Updated: 2015-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-07-31

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.

Conditions

Fecal Incontinence; Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment

Intra-anal Oxymetazoline gel once daily

Group Type: EXPERIMENTAL

Oxymetazoline gel

Intervention Type: DRUG

Oxymetazoline gel applied intra-anally once daily

Placebo

Intra-anal Placebo gel once daily

Group Type: PLACEBO_COMPARATOR

Placebo gel

Intervention Type: DRUG

Placebo gel applied intra-anally once daily

Interventions

Oxymetazoline gel

Oxymetazoline gel applied intra-anally once daily

Intervention Type: DRUG

Placebo gel

Placebo gel applied intra-anally once daily

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RDD Pharma Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Semmelweis Egyetem I. sz. Belgyógyászati Klinika

Budapest, , Hungary

Countries

Hungary

Other Identifiers

RDD 116

Identifier Type: -

Identifier Source: org_study_id