Safety Study of hMaxi-K Gene Transfer to Treat Overactive Bladder and Detrusor Overactivity

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ion Channel Innovations; Urovant Sciences GmbH
• Collaborator: Ion Channel Innovations

Criteria

Inclusion Criteria:

• Healthy women of 18 years of age or older and of non-childbearing potential

• Clinical symptoms of overactive bladder for 6 months or longer including at least one of the following:

1. frequent urination (that is, having to go to the bathroom 8 or more times per day);

2. symptoms of urinary urgency, which is experiencing a sudden need to pass urine that is difficult to hold back; or the complaint of waking at night two ore more times to urinate;

3. urge urinary incontinence, which is the complaint of leakage of urine that cannot be stopped, accompanied by or immediately preceded by urgency 5 or more times per week.

• Non-response or poor tolerance to previous treatment for symptoms of overactive bladder and do not wish to continue with that treatment.

Exclusion Criteria:

• 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