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The primary objective of this study is to evaluate the safety of a single treatment of hMaxi-K compared to placebo (PBS-20% sucrose) administered by direct bladder wall injections. Two dose levels (16000 µg and 24000 µg; 20 or 30 bladder wall injections, respectively) in females with moderate Overactive Bladder/Detrusor overactivity (OAB/DO) of ≥6 months duration will be evaluated. In each dose level, 6 participants will receive hMaxi-K and 3 will receive placebo.
Full description
This is a Phase 1 double-blind, placebo-controlled study assessing the safety and activity of 2 escalating doses of hMaxi-K gene transfer by direct injection into the bladder wall in female participants with OAB/DO.
The safety parameters to be monitored include: adverse events, clinical laboratory tests, electrocardiograms, and physical examinations.
The secondary objective is to evaluate the efficacy of multiple intramuscular injections of hMaxi-K compared to the control group. Efficacy parameters that will be evaluated are: number of micturitions per 24 hours, volume per micturition, incontinence episodes, pad weight measurement of accidental bladder leaks, uninhibited contractions during cystoscopy and other cystoscopic evaluations, and general and bladder-specific quality of life assessments (Kings Health Questionnaire, SF-12 Health Survey, and International Consultation on Incontinence Questionnaire [ICIQ-SF]).
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Inclusion criteria
Healthy women of ≥18 years of age and non-childbearing potential
Symptoms of overactive bladder for ≥6 months including at least one of the following:
Detrusor overactivity with ≥1 uncontrolled phasic contraction(s) of the detrusor of at least 5 centimeters/H20 pressure documented on cystometry at Screening Visit 1A
Residual urine volume of ≤200 milliliters (ml)
Non-response or poor tolerance to previous treatment for symptoms of OAB/urinary incontinence and do not wish to continue these treatments
Have screening laboratory values and electrocardiogram that are within the normal range
Able to understand study requirements (i.e., literate in English), give written informed consent, and comply with all study procedures and requirements.
Exclusion criteria
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Interventional model
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13 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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