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

AbbVie

Status and phase: Completed; Phase 4

Conditions: Overactive Detrusor; Neurogenic Bladder

Treatments: Drug: Oxybutynin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01192568

OG09002

Details and patient eligibility

About

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.

Full description

This study will use a two-part, multicenter, dose-titration study in pediatric patients with a detrusor overactivity associated with a neurological condition

Enrollment: 52 patients

Sex: All

Ages: 3 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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52 participants in 3 patient groups, including a placebo group

DB: OTG (Pre-Amend 3)

Experimental group

Description:

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.

Treatment:

Drug: Oxybutynin

OL: OTG (Post-Amend 3)

Experimental group

Description:

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.

Treatment:

Drug: Oxybutynin

DB: Placebo (Pre-Amend 3)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo