Safety Study of hMaxi-K Gene Transfer to Treat Overactive Bladder Syndrome and Detrusor Overactivity
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|ClinicalTrials.gov Identifier: NCT00495053|
Recruitment Status : Completed
First Posted : July 2, 2007
Last Update Posted : March 22, 2012
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).
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder||Genetic: hMaxi-K Drug: hMaxi-K Other: Placebo||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||April 2007|
|Primary Completion Date :||July 2008|
|Study Completion Date :||November 2009|
|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 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. ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495053
|United States, Connecticut|
|Branford, Connecticut, United States, 06405|
|Study Director:||Arnold Melman, MD||Ion Channel Innovations|