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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299557
• Other study ID #: RDD 116
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 17, 2014
• Last updated: July 26, 2015
• Start date: November 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: RDD Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• Oxymetazoline gel
Oxymetazoline gel applied intra-anally once daily
• Placebo gel
Placebo gel applied intra-anally once daily

Locations

Country	Name	City	State
Hungary	Semmelweis Egyetem I. sz. Belgyógyászati Klinika	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
RDD Pharma Ltd

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the effect of Oxymetazoline gel on fecal incontinence episodes in the 8 hours following application.		4 weeks	No
Secondary	Pharmacokinetics (area under the curve [AUC]), peak concentration and half life time (T 1/2) of Oxymetazoline;		4 weeks	No
Secondary	Number of participants with adverse events		4 weeks	Yes