Safety Study of hMaxi-K Gene Transfer to Treat Overactive Bladder and Detrusor Overactivity
Status:
Terminated
Trial end date:
2009-11-01
Target enrollment:
Participant gender:
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).