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

NCT02299557 | Completed Phase 1

• 1 other identifier: RDD 116
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• To examine the effect of Oxymetazoline gel on fecal incontinence episodes in the 8 hours following application.

  4 weeks

Secondary Outcomes (2)

• Pharmacokinetics (area under the curve [AUC]), peak concentration and half life time (T 1/2) of Oxymetazoline;

  4 weeks

• Number of participants with adverse events

  4 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

Intra-anal Oxymetazoline gel once daily

Drug: Oxymetazoline gel

Placebo

PLACEBO COMPARATOR

Intra-anal Placebo gel once daily

Drug: Placebo gel

Interventions

Oxymetazoline gel DRUG

Oxymetazoline gel applied intra-anally once daily

Treatment

Placebo gel DRUG

Placebo gel applied intra-anally once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RDD Pharma Ltd: lead

Study Sites (1)

Semmelweis Egyetem I. sz. Belgyógyászati Klinika

Budapest, Hungary

Location

MeSH Terms

Conditions

Fecal Incontinence; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 24, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

HU (1)