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NCT01870037 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study With OAB Assessing the Safety and Activity of hMaxi-K Gene Transfer
A Phase 1 study, sponsored by Urovant Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01870037 is a Phase 1 study that has completed, run by Urovant Sciences. The registered enrollment target is 13 participants.
The verdict
NCT01870037, a Phase 1 study, has completed, sponsored by Urovant Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety of a single treatment of hMaxi-K compared to placebo (PBS-20% sucrose) administered by direct bladder wall injections. Two dose levels (16000 µg and 24000 µg; 20 or 30 bladder wall injections, respectively) in females with moderate Overactive Bladder/Detrusor overactivity (OAB/DO) of ≥6 months duration will be evaluated. In each dose level, 6 participants will receive hMaxi-K and 3 will receive placebo.
Interventions
- DRUG Placebo (PBS-20% sucrose)
- DRUG hMaxi-K
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2013-01 |
| Est. Completion | 2018-02-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01870037
The ClinicalTrials.gov registry entry for NCT01870037 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 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 (PBS-20% sucrose) is the first listed.
NCT01870037 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01870037 about?
NCT01870037 is a clinical study titled "Phase 1 Study With OAB Assessing the Safety and Activity of hMaxi-K Gene Transfer". The primary objective of this study is to evaluate the safety of a single treatment of hMaxi-K compared to placebo (PBS-20% sucrose) administered by direct bladder wall injections. Two dose levels (16000 µg and 24000 µg; 20 or 30 bladder wall injections, respectively) in females with moderate Overac...
What is the current status of trial NCT01870037?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2013-01. Estimated completion is 2018-02-17.
What interventions are being tested in trial NCT01870037?
The interventions under investigation include: Placebo (PBS-20% sucrose) (DRUG), hMaxi-K (DRUG).
Who is sponsoring clinical trial NCT01870037?
This trial is sponsored by Urovant Sciences, which has 10 total clinical trials registered on ClinicalTrials.gov.
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