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NCT01893138 · ClinicalTrials.gov registry record · Phase 3
Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
A Phase 3 study, sponsored by Cook MyoSite.
- Completed
- Registry status
- Phase 3
- Development phase
- 311
- Enrollment target
NCT01893138 is a Phase 3 study that has completed, run by Cook MyoSite. The registered enrollment target is 311 participants.
The verdict
NCT01893138, a Phase 3 study, has completed, sponsored by Cook MyoSite.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 311 participants
- Enrollment target
Study Summary
This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.
Interventions
- OTHER Placebo
- BIOLOGICAL Iltamiocel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 311 participants |
| Start Date | 2013-11-21 |
| Est. Completion | 2020-11-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01893138
The ClinicalTrials.gov registry entry for NCT01893138 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 311 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cook MyoSite, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01893138 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01893138 about?
NCT01893138 is a clinical study titled "Autologous Muscle Derived Cells for Female Urinary Sphincter Repair". This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence...
What is the current status of trial NCT01893138?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 311 participants. The study started on 2013-11-21. Estimated completion is 2020-11-10.
What interventions are being tested in trial NCT01893138?
The interventions under investigation include: Placebo (OTHER), Iltamiocel (BIOLOGICAL).
Who is sponsoring clinical trial NCT01893138?
This trial is sponsored by Cook MyoSite, which has 5 total clinical trials registered on ClinicalTrials.gov.
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