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

NCT00495053 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-06-28

No results posted yet for this 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).

Conditions

Interventions

DRUG

hMaxi-K

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

OTHER

Placebo

Matching placebo (PBS-20% sucrose)

Sponsors & Collaborators

  • Ion Channel Innovations

    collaborator INDUSTRY

  • Urovant Sciences GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-07-31
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00495053 on ClinicalTrials.gov