Status:
COMPLETED
Phase 1 Study With OAB Assessing the Safety and Activity of hMaxi-K Gene Transfer
Lead Sponsor:
Urovant Sciences GmbH
Collaborating Sponsors:
Ion Channel Innovations
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
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 (16...
Detailed 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 participan...
Eligibility Criteria
Inclusion
- 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:
- Frequent micturition ≥8 times per 24 hours
- Urinary urgency or nocturia
- Urge urinary incontinence five or more incontinence episodes per week
- 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
- A woman with a positive serum (HCG) pregnancy test or who is lactating
- History of three or more culture-documented recurrent urinary tract infections per year
- Current history or previous diagnosis of painful bladder syndrome (interstitial cystitis) with pain in the region of the pelvis, perineum, or lower abdomen relieved by voiding
- Current history of neurological bladder dysfunction
- A life expectancy of less than 12 months
- Current history of Grade 2 or greater cystocele
- An indwelling urethral catheter or need for clean intermittent self-catheterization
- Recent heart attack
- Uncontrolled diabetes
- Latex allergy
- Stress urinary incontinence as determined by observation of the participant coughing while standing with a full bladder and/or response of 2 or 3 on the following Stress Urinary Incontinence question: Do you experience leakage when laughing, coughing, lifting heavy objects or other types of discreet, moderately intense activities? 0=NONE: No leakage. 1=MILD: Minimal leakage on rare occasions during these types of activities; easily tolerated; do not use pads for this. 2=MODERATE: Enough leakage that it requires occasional use of pads and may interfere with usual activity and tasks. 3=SEVERE: Extreme leakage and discomfort that stops all activity and tasks and requires the use of pads on all occasions
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2018
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01870037
Start Date
January 1 2013
End Date
February 17 2018
Last Update
May 8 2019
Active Locations (3)
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1
AccuMed Research Associates
Garden City, New York, United States, 11530
2
NYU
New York, New York, United States, 10016
3
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, United States, 12601