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Overactive BladderPhase 1OABNCT01870037

Phase 1 Study With OAB Assessing the Safety and Activity of hMaxi-K Gene Transfer

A Phase 1 study testing hMaxi-K in people with Overactive Bladder, run by Urovant Sciences GmbH at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Overactive Bladder
What is being tested?
hMaxi-K
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
13 participants
Where
3 sitesUnited States
Study dates
Jan 2013to 17 Feb 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • AccuMed Research Associates

    Garden City, New York, 11530

  • NYU

    New York, New York, 10016

  • Premier Medical Group of the Hudson Valley, PC

    Poughkeepsie, New York, 12601

Other trials in United States

About this study

Official title: Phase 1 Double Blind, Placebo Controlled Study Assessing Safety and Activity Of 2 Escalating Doses of hMaxi-K Gene Transfer By Direct Injection Into the Bladder Wall In Female Subjects With OAB

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.

Read the 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 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]).

Being tested
Placebo (PBS-20% sucrose), hMaxi-K
Keywords
Overactive Bladder, OAB, gene therapy
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo (PBS-20% sucrose)Drug

    Also called Placebo

  • hMaxi-KDrug

    Also called URO-902

    Single treatment/2 escalating dose levels (16000 µg and 24000 µg by intramuscular injection)

Study groups in NCT01870037
Study groupRoleWhat they receive
Placebo (PBS-20% sucrose)Placebo comparatorPBS-20% sucrose administered during two single-treatment dose levels (16000 micrograms [µg] and 24000 µg) by direct bladder wall intramuscular injections, 20 to 30 injections depending on active dose comparator.
Receives: Drug: Placebo (PBS-20% sucrose)
hMaxi-K 16000 µgExperimentalSingle treatment (16000 µg by 20 intramuscular injections). A total of 6 participants will receive hMaxi-K, and 3 will receive placebo.
Receives: Drug: hMaxi-K
hMaxi-K 24000 µgExperimentalSingle treatment (24000 µg by 30 intramuscular injections). A total of 6 participants will receive hMaxi-K, and 3 will receive placebo.
Receives: Drug: hMaxi-K

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months (24 weeks) per participant

  2. Number of participants with any treatment-emergent adverse event during the Safety Follow-up Period

    Measured: 18 months

  3. Number of participants with any clinically significant clinical laboratory test value during the Treatment Period

    Measured: 6 months (24 weeks) per participant

  4. Number of participants with any clinically significant clinical laboratory test value during the Safety Follow-up Period

    Measured: 18 months

  5. Number of participants with any clinically significant electrocardiogram finding during the Treatment Period

    Measured: 6 months (24 weeks) per participant

  6. Number of participants with any clinically significant electrocardiogram finding during the Safety Follow-up Period

    Measured: 18 months

  7. Number of participants with any clinically significant physical examination finding during the Treatment Period

    Measured: 6 months (24 weeks) per participant

  8. Number of participants with any clinically significant physical examination finding during the Safety Follow-up Period

    Measured: 18 months

Secondary outcomes (8)

  1. Change from Baseline in the number of micturitions per day

    Measured: Baseline; 6 months (24 weeks) per participant

  2. Change from Baseline in the volume of micturitions

    Measured: Baseline; 6 months (24 weeks) per participant

  3. Change from Baseline in incontinence episodes

    Measured: Baseline; 6 months (24 weeks) per participant

  4. Change from Baseline in pad weight

    Measured: Baseline; 6 months (24 weeks) per participant

  5. Change from Baseline in uninhibited contractions during cystoscopy

    Measured: Baseline; 6 months (24 weeks) per participant

  6. Change from Baseline in the participant rating of the Kings Health Questionnaire (KHQ) score

    Measured: Baseline; 6 months (24 weeks) per participant

  7. Change from Baseline in the International Consultation on Incontinence Questionnaire-Short Form score

    Measured: Baseline; 6 months (24 weeks) per participant

  8. Change from Baseline in the Short Form-12 (SF-12) score

    Measured: Baseline; 6 months (24 weeks) per participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionJun 2017
  4. Study completion17 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Sequential
Model description
sequential, dose escalation
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01870037
Sponsor's protocol ID
ION 03-OAB
Acronym
OAB
Status last verified
May 2019
First submitted
3 Jun 2013
Last updated
8 May 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: individual participant data will not be shared

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing hMaxi-K in people with Overactive Bladder, run by Urovant Sciences GmbH at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with any treatment-emergent adverse event during the Treatment Period (time frame: 6 months (24 weeks) per participant). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01870037.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.

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