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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: Clinical Trial Phase 1 study, sponsored by Urovant Sciences.
NCT00495053 is a Phase 1 study that was terminated before completion, run by Urovant Sciences. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00495053 stopped before completion
NCT00495053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00495053 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT00495053's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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