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

Primary Purpose

Fecal Incontinence, Spinal Cord Injury

Status
Completed
Phase
Phase 1
Locations
Hungary
Study Type
Interventional
Intervention
Oxymetazoline gel
Placebo gel
Sponsored by
RDD Pharma Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Semmelweis Egyetem I. sz. Belgyógyászati Klinika

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

Intra-anal Oxymetazoline gel once daily

Intra-anal Placebo gel once daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 17, 2014
Last Updated
July 26, 2015
Sponsor
RDD Pharma Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02299557
Brief Title
The Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients
Official Title
A Double Blind Study to Examine the Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RDD Pharma Ltd

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence, Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Intra-anal Oxymetazoline gel once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intra-anal Placebo gel once daily
Intervention Type
Drug
Intervention Name(s)
Oxymetazoline gel
Intervention Description
Oxymetazoline gel applied intra-anally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo gel
Intervention Description
Placebo gel applied intra-anally once daily
Primary Outcome Measure Information:
Title
To examine the effect of Oxymetazoline gel on fecal incontinence episodes in the 8 hours following application.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetics (area under the curve [AUC]), peak concentration and half life time (T 1/2) of Oxymetazoline;
Time Frame
4 weeks
Title
Number of participants with adverse events
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Semmelweis Egyetem I. sz. Belgyógyászati Klinika
City
Budapest
Country
Hungary

12. IPD Sharing Statement

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

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