NCT00224029

Brief Summary

This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2004

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
2 years until next milestone

Results Posted

Study results publicly available

April 30, 2010

Completed
Last Updated

April 30, 2010

Status Verified

April 1, 2010

Enrollment Period

1 year

First QC Date

September 13, 2005

Results QC Date

November 13, 2009

Last Update Submit

April 7, 2010

Conditions

Detrusor Hyperreflexia

Outcome Measures

Primary Outcomes (1)

  • Average Number of Catheterizations Without Leaking Per Day

    Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary.

    8 weeks

Secondary Outcomes (3)

  • Patch Adhesion

    8 weeks

  • Urodynamic Measurements

    8 weeks

  • Urinary Leakage and Catheterization Data

    8 weeks

Study Arms (1)

Oxybutynin transdermal system

EXPERIMENTAL

Oxybutynin transdermal system 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day dosing

Drug: Oxybutynin transdermal system

Interventions

Oxybutynin transdermal systemDRUG

3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration

Also known as: Oxytrol
Oxybutynin transdermal system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age at day of consent;
  • Is a male, or is a non-pregnant non-lactating female who is either of non-child-bearing potential, or is using adequate means of birth control;
  • Has a h/o of urinary incontinence from neurogenic bladder of spinal cord injury etiology;
  • Has impairment based on the American Spinal Injury Association (ASIA);
  • Use clean intermittent catheterization;
  • Has urinary incontinence between scheduled catheterization;
  • Capable of understanding and complying with the protocol.

You may not qualify if:

  • Have one or more treatable conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency;
  • Have any medical condition that precludes their participation in the study, or may confound the outcome of the study;
  • History of major lower urinary tract surgery, procedures;
  • Has an active skin disorder, affecting TDS application site areas;
  • Hypersensitivity to the investigational drug;
  • Has participated in any study involving administration of an investigational compound within 30 days before this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

The Bronx, New York, United States

Location

Unknown Facility

Chapel Hill, North Carolina, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Related Publications (1)

  • Kennelly MJ, Lemack GE, Foote JE, Trop CS. Efficacy and safety of oxybutynin transdermal system in spinal cord injury patients with neurogenic detrusor overactivity and incontinence: an open-label, dose-titration study. Urology. 2009 Oct;74(4):741-5. doi: 10.1016/j.urology.2009.05.008. Epub 2009 Jul 22.

    PMID: 19628264RESULT

MeSH Terms

Interventions

oxybutynin

Results Point of Contact

Title
Gary Hoel, RPh, PhD, Executive Director of Clinical Research
Organization
Watson Laboratories, Inc.
gary.hoel@watson.com
801-588-6641

Study Officials

  • Gary Hoel, RPh, PhD

    Watson Laboratories, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

December 1, 2004

Primary Completion

December 1, 2005

Study Completion

May 1, 2008

Last Updated

April 30, 2010

Results First Posted

April 30, 2010

Record last verified: 2010-04

Locations

US(6)