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TerminatedNCT00495053Updated Jun 28, 2019

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

A Phase 1 interventional study of hMaxi-K and Placebo in Overactive Bladder, sponsored by Urovant Sciences GmbH. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-28.

Sponsored by Urovant Sciences GmbH (part of Sumitomo Pharma Co., Ltd.) · Phase 1, Interventional, and Treatment

Why this study was terminated
Slow enrollment and financial issues
Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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).

Read the detailed description

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 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 (ICIQ-SF), and pad weight measurement of accidental bladder leaks.

02

Conditions studied

  • Overactive Bladder

Keywords

  • overactive bladder, urinary urgency
03

In context

Urinary Bladder, Overactive

864 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's enrollment of 21 is below the median of 70 across 660 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Urovant Sciences GmbH is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

First submitted before Urovant Sciences GmbH became part of Sumitomo Pharma Co., Ltd..

Browse Urovant Sciences GmbH studies →All Sumitomo Pharma Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    hMaxi-K 5000 µg/mL

    5000 micrograms (µg)/90 milliliter (mL) intravesical instillation

    Drug: hMaxi-K

  • Experimental
    hMaxi-K 10000 µg/mL

    10000 µg/90 mL intravesical instillation

    Drug: hMaxi-K

  • Placebo comparator
    Placebo

    Matching placebo (PBS-20% sucrose)

    Other: Placebo

Interventions

  • DrughMaxi-K

    Two dose levels (5000 µg/90 mL intravesical instillation and 10000 µg/90 mL intravesical instillation)

    Also known as: URO-902

  • OtherPlacebo

    Matching placebo (PBS-20% sucrose)

06

What researchers measure

Primary outcomes

  1. Number of participants with any treatment-emergent adverse event during the treatment period

    Time frame: 6 months (24 weeks per participant)

  2. Number of participants with any treatment-emergent adverse event during the safety follow-up period

    Time frame: 18 months

  3. Number of participants with any abnormal, clinically significant clinical laboratory test value during the treatment period

    Time frame: 6 months (24 weeks per participant)

  4. Number of participants with any abnormal, clinically significant clinical laboratory test value during the safety follow-up period

    Time frame: 18 months

  5. Number of participants with any abnormal, clinically significant clinical electrocardiogram value during the treatment period

    Time frame: 6 months (24 weeks per participant)

  6. Number of participants with any abnormal, clinically significant clinical electrocardiogram value during the safety follow-up period

    Time frame: 18 months

  7. Number of participants with any abnormal, clinically significant clinical physical examination finding during the treatment period

    Time frame: 6 months (24 weeks per participant)

  8. Number of participants with any abnormal, clinically significant clinical physical examination finding during the safety follow-up period

    Time frame: 18 months

Secondary outcomes

  1. Change from Baseline in the mean number of micturitions per 24 hours

    Time frame: Baseline; 6 months (24 weeks) per participant

  2. Change from Baseline in the mean number of urge incontinence episodes per 24 hours (collected over a 3-day period)

    Time frame: Baseline; 6 months (24 weeks) per participant

  3. Change from Baseline in the mean number of urgency episodes per 24 hours

    Time frame: Baseline; 6 months (24 weeks) per participant

  4. Change from Baseline in the overall maximum bladder capacity

    Time frame: Baseline; 6 months (24 weeks) per participant

  5. Change from Baseline in the number of uninhibited contractions during the cystometry procedure

    Time frame: Baseline; 6 months (24 weeks) per participant

  6. Change from Baseline in the participant rating of urgency score

    Time frame: Baseline; 6 months (24 weeks) per participant

  7. Change from Baseline in the participant rating of perceived bladder condition severity

    Time frame: Baseline; 6 months (24 weeks) per participant

  8. Number of participants with the indicated response to the following question, as a measure of the participants' assessment of response to treatment: "Has the treatment been of benefit to you"?

    Time frame: 6 months (24 weeks) per participant

  9. Change from Baseline in the Kings Health Questionnaire-Quality of Life (KHQ-QOL) general health perceptions domain score and impact on life domain score

    Time frame: Baseline; 6 months (24 weeks) per participant

  10. Change from Baseline in the Short Form-12 (SF-12) Health Survey

    Time frame: Baseline; 6 months (24 weeks) per participant

  11. Change from Baseline in the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)

    Time frame: Baseline; 6 months (24 weeks) per participant

  12. Change from Baseline in pad weight

    Time frame: Baseline; 6 months (24 weeks) per participant

07

Study locations

1 site
  • CE3, Inc.
    Branford, Connecticut 06405, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2007, a primary completion of Jul 2008 and a completion of Nov 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2007
First posted
Jul 2, 2007
Start
Apr 2007
Primary completionActual
Jul 2008
CompletionActual
Nov 2009
Last update
Jun 28, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00495053
Lead sponsor
Urovant Sciences GmbH
Collaborators
Ion Channel Innovations
Responsible party
Sponsor
First posted
Jul 2, 2007
Start date
Apr 2007
Primary completion
Jul 2008
Completion
Nov 2009
Last update
Jun 28, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: URO-902

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