Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder

NCT01192568 | Completed Phase 4 Results FDA Drug

• 1 other identifier: OG09002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 10

Brief Summary

This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then return to the clinic for a potential dose titration. At this time their dose may be adjusted up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the individual response and tolerability. The total treatment time is 14 weeks and total time on the study is 16 weeks.

Conditions

Overactive Detrusor; Neurogenic Bladder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Percent of Catheterizations Without a Leaking Accident at Week 6

  The primary efficacy endpoint is the change from baseline to Week 6 of treatment or the last observation carried forward in percentage of catheterizations without a leaking accident as recorded in a 2-day urinary diary.

  Baseline (Week 0) up to Week 6

Secondary Outcomes (3)

• Change From Baseline in Average Volume of Urine Collected Per Catheterization at Week 6

  Baseline (Week 0) up to week 6

• Change From Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at Week 6

  Baseline (Week 0) up to Week 6

• Change From Baseline in Average Number of Catheterizations Per Day at Week 6

  Baseline (Week 0) up to Week 6

Study Arms (3)

DB: OTG (Pre-Amend 3)

EXPERIMENTAL

Double-Blind Oxybutynin Chloride topical gel (OTG) (Pre-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose), or 1 g sachets, applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks.

Drug: Oxybutynin

OL: OTG (Post-Amend 3)

EXPERIMENTAL

Open-Label Oxybutynin Chloride topical gel (OTG) (Pre \& Post-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose for Pre- and Post-Amendment 3), or 1 g sachets, applied transdermally once daily for 14 weeks.

Drug: Oxybutynin

DB: Placebo (Pre-Amend 3)

PLACEBO COMPARATOR

Double-Blind Placebo (Pre-Amendment 3) Placebo Gel sachets applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks.

Drug: Placebo

Interventions

Oxybutynin DRUG

10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.

Also known as: Gelnique

DB: OTG (Pre-Amend 3); OL: OTG (Post-Amend 3)

Placebo DRUG

Topical gel

DB: Placebo (Pre-Amend 3)

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years to \< 17 years
• Neurogenic bladder
• Neurological condition
• CIC

You may not qualify if:

• Have anatomical bladder abnormalities
• Sensitivity to anticholinergics
• Bladder augmentation

Sponsors & Collaborators

• AbbVie: lead

Study Sites (10)

Loma Linda University /ID# 236889

Loma Linda, California, 92354, United States

Location

Child Hosp of Orange County,CA /ID# 237517

Orange, California, 92868, United States

Location

Children's Hospital Colorado - Aurora /ID# 237620

Aurora, Colorado, 80045, United States

Location

Augusta University Medical Center /ID# 238188

Augusta, Georgia, 30912-0004, United States

Location

University of Mississippi Medical Center /ID# 238065

Jackson, Mississippi, 39216-4500, United States

Location

Albany Medical College /ID# 236880

Albany, New York, 12208, United States

Location

Duke University /ID# 237494

Durham, North Carolina, 27710, United States

Location

Duplicate_Oregon Health & Science University /ID# 234354

Portland, Oregon, 97239-3011, United States

Location

Cook Children's Med. Center /ID# 237538

Fort Worth, Texas, 76104, United States

Location

Child Hosp of the King's Dtr's /ID# 237799

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• Cartwright PC, Coplen DE, Kogan BA, Volinn W, Finan E, Hoel G. Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity. J Urol. 2009 Oct;182(4):1548-54. doi: 10.1016/j.juro.2009.06.058. Epub 2009 Aug 15.

  PMID: 19683731 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Bladder, Neurogenic

Interventions

oxybutynin

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases

Limitations and Caveats

AbbVie has decided to discontinue further subject enrollment in the OG09002 (Oxybutynin) study. This decision is not based on a safety or an efficacy signal; rather this decision was made because of a change in AbbVie's development.

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pre-Amendment 3: All subjects, site personnel and Watson and CRO personnel directly involved in the execution of the study were blinded. Post-Amendment 3: All subjects Open-label
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study was initiated as a double-blind, placebo-controlled study with an open-label extension and was amended (in Protocol Amendment 3) to continue to enroll subjects under only open-label treatment.

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: September 1, 2010
• Study Start: May 17, 2011
• Primary Completion: August 29, 2023
• Study Completion: October 24, 2023
• Last Updated: September 4, 2024
• Results First Posted: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (10)