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Tracking Information | |||||
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First Received Date † | June 29, 2007 | ||||
Last Updated Date | June 12, 2008 | ||||
Start Date † | April 2007 | ||||
Current Primary Outcome Measures † |
The primary objective of this study is to evaluate all safety parameters occurring subsequent to administration of a single intravesical instillation of study drug. [ Time Frame: 6 months (24 weeks) per participant with an additional 18 month safety follow-up. ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00495053 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
The secondary objective is to evaluate efficacy of a single intravesical instillation of hMaxi-K compared to the control group. [ Time Frame: 6 months (24 weeks) per participant ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Safety Study of hMaxi-K Gene Transfer to Treat Overactive Bladder Syndrome and Detrusor Overactivity | ||||
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 | ||||
Brief 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. 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). |
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Detailed Description | 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. |
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Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Overactive Bladder | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 39 | ||||
Estimated Completion Date | September 2008 | ||||
Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† |
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Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00495053 | ||||
Responsible Party | Dr. Arnorld Melman/Directing Member, Ion Channel Innovations, LLC | ||||
Secondary IDs †† | |||||
Study Sponsor † | Ion Channel Innovations | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Ion Channel Innovations | ||||
Verification Date | June 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |