Safety Study of hMaxi-K Gene Transfer to Treat Overactive Bladder and Detrusor Overactivity

Summary

The purpose of this study is to evaluate the safety of a new product that uses human gene transfer (called hMaxi-K) when it is given to patients with overactive bladder. Human gene transfer is a new type of therapy that is the process of placing genetic material (DNA or RNA) into a person. The primary objective of this study is to evaluate safety parameters occurring subsequent to administration of a single intravesical instillation of study drug. Two different dose groups of hMaxi-K will be tested in this study: 5000 and 10000 micrograms. A 15000 microgram group was planned; however, the study was terminated before participants were dosed. hMaxi-K will be given as a single administration into the bladder through a catheter. Each women's participation in the study will last for up to 24 weeks (followed by an additional 18-month follow-up period).

Timeline

Start

2007-04

Primary completion

2008-07

Completion

2009-11

Outcome

Outcome not reported

Stopped (Enrollment): “Slow enrollment and financial issues”

Drugs

Indications