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Sponsored by: |
Ion Channel Innovations |
Information provided by: | Ion Channel Innovations |
ClinicalTrials.gov Identifier: | NCT00495053 |
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.
Three different dose groups of hMaxi-K will be tested in this study consisting of 5000, 10,000 and 15,000 micrograms. 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).
Condition | Intervention | Phase |
Overactive Bladder |
Genetic: hMaxi-K Drug: hMaxi-K Other: Placebo |
Phase I |
Drug Information available for: | Sucrose |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1 Multicenter Study of Three Escalating Doses of hMaxi-K Gene Transfer in Female Participants With Overactive Bladder Syndrome and Detrusor Overactivity |
Estimated Enrollment: | 39 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
hMaxi-K: Active Comparator |
Genetic: hMaxi-K
Three dose levels (5000µg /90 mL intravesical instillation, 10000µg/90 mL intravesical instillation, and 15000µg/90 mL intravesical instillation)
Drug: hMaxi-K
Gene Transfer
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Placebo: Placebo Comparator |
Genetic: hMaxi-K
Three dose levels (5000µg /90 mL intravesical instillation, 10000µg/90 mL intravesical instillation, and 15000µg/90 mL intravesical instillation)
Other: Placebo
placebo (PBS-20% sucrose)
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The safety parameters to be monitored include: adverse events, clinical laboratory tests, electrocardiograms, physical examinations.
The secondary objectives is to evaluate 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, weight measurement of accidental bladder leaks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
clinical symptoms of overactive bladder for 6 months or longer including at least one of the following:
Exclusion Criteria:
Contact: Wendy Y Espinal | 203-444-4941 | wespinal@ce3inc.com |
United States, Connecticut | |||||
CE3, Inc. | Recruiting | ||||
Branford, Connecticut, United States, 06405 | |||||
Contact: Wendy Y Espinal 203-444-4941 wespinal@ce3inc.com |
Ion Channel Innovations |
Study Director: | Arnold Melman, MD | Ion Channel Innovations |
Responsible Party: | Ion Channel Innovations, LLC ( Dr. Arnorld Melman/Directing Member ) |
Study ID Numbers: | ION-02 |
First Received: | June 29, 2007 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00495053 |
Health Authority: | United States: Food and Drug Administration |
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