Safety Study of hMaxi-K Gene Transfer to Treat Overactive Bladder Syndrome and Detrusor Overactivity
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.
Three different dose groups of hMaxi-K will be tested in this study consisting of 5000, 10,000 and 15,000 micrograms. 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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 1 Multicenter Study of Three Escalating Doses of hMaxi-K Gene Transfer in Female Participants With Overactive Bladder Syndrome and Detrusor Overactivity|
- The primary objective of this study is to evaluate all safety parameters occurring subsequent to administration of a single intravesical instillation of study drug. [ Time Frame: 6 months (24 weeks) per participant with an additional 18 month safety follow-up. ] [ Designated as safety issue: Yes ]
- The secondary objective is to evaluate efficacy of a single intravesical instillation of hMaxi-K compared to the control group. [ Time Frame: 6 months (24 weeks) per participant ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||November 2009|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: hMaxi-K||
Three dose levels (5000µg /90 mL intravesical instillation, 10000µg/90 mL intravesical instillation, and 15000µg/90 mL intravesical instillation)Drug: hMaxi-K
|Placebo Comparator: Placebo||
Three dose levels (5000µg /90 mL intravesical instillation, 10000µg/90 mL intravesical instillation, and 15000µg/90 mL intravesical instillation)Other: Placebo
placebo (PBS-20% sucrose)
The safety parameters to be monitored include: adverse events, clinical laboratory tests, electrocardiograms, physical examinations.
The secondary objectives is to evaluate efficacy of a single intravesical instillation of hMaxi-K compared to the control group. Efficacy parameters that will be evaluated are: mean number of micturitions per 24 hours, mean number of urge incontinence episodes per 24 hours, mean number of urgency episodes per 24 hours, overall maximum bladder capacity, number of uninhibited contractions during the cystometry procedure, participant rating of urgency score, participant rating of perceived bladder condition severity, participant assessment of response to treatment, participant rating of Quality of Life (Kings Health Questionnaire), SF-12 Health Survey, International consultation on incontinence questionnaire, weight measurement of accidental bladder leaks.