Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00495053 · ClinicalTrials.gov registry record · Phase 1
Safety Study of hMaxi-K Gene Transfer to Treat Overactive Bladder and Detrusor Overactivity
A Phase 1 study, sponsored by Urovant Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT00495053 is a Phase 1 study that was terminated before completion, run by Urovant Sciences. The registered enrollment target is 21 participants.
The verdict
NCT00495053, a Phase 1 study, was terminated before completion, sponsored by Urovant Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
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).
Interventions
- OTHER Placebo
- DRUG hMaxi-K
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2007-04 |
| Est. Completion | 2009-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00495053
The ClinicalTrials.gov registry entry for NCT00495053 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Urovant Sciences, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00495053 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00495053 about?
NCT00495053 is a clinical study titled "Safety Study of hMaxi-K Gene Transfer to Treat Overactive Bladder and Detrusor Overactivity". 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 prima...
What is the current status of trial NCT00495053?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2007-04. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00495053?
The interventions under investigation include: Placebo (OTHER), hMaxi-K (DRUG).
Who is sponsoring clinical trial NCT00495053?
This trial is sponsored by Urovant Sciences, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.