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NCT03129126 · ClinicalTrials.gov registry record · Phase 2
The Safety, Tolerability and Efficacy of LP-10 in Subjects With Refractory Moderate to Severe Hemorrhagic Cystitis
A Phase 2 study, sponsored by Lipella Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT03129126 is a Phase 2 study that has completed, run by Lipella Pharmaceuticals. The registered enrollment target is 13 participants.
The verdict
NCT03129126, a Phase 2 study, has completed, sponsored by Lipella Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and tolerability of three doses of LP-10 (intravesical tacrolimus). Twelve subjects meeting the inclusion and exclusion criteria will be enrolled and treated in a prospective and multi-center trial with LP-10. The proposed trial will recruit 12 subjects in a dose-escalation trial where 4 subjects will be allocated into each one of three groups.
Interventions
- DRUG LP-10
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2023-09-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03129126
The ClinicalTrials.gov registry entry for NCT03129126 describes a study currently listed as completed, categorized as Phase 2. 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 Lipella Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LP-10 is the first listed.
NCT03129126 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03129126 about?
NCT03129126 is a clinical study titled "The Safety, Tolerability and Efficacy of LP-10 in Subjects With Refractory Moderate to Severe Hemorrhagic Cystitis". The purpose of this study is to assess the safety and tolerability of three doses of LP-10 (intravesical tacrolimus). Twelve subjects meeting the inclusion and exclusion criteria will be enrolled and treated in a prospective and multi-center trial with LP-10. The proposed trial will recruit 12 subje...
What is the current status of trial NCT03129126?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2020-10-01. Estimated completion is 2023-09-29.
What interventions are being tested in trial NCT03129126?
The interventions under investigation include: LP-10 (DRUG).
Who is sponsoring clinical trial NCT03129126?
This trial is sponsored by Lipella Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
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