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NCT01393223 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome
A Phase 2 study, sponsored by Lipella Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT01393223 is a Phase 2 study that has completed, run by Lipella Pharmaceuticals. The registered enrollment target is 21 participants.
The verdict
NCT01393223, a Phase 2 study, has completed, sponsored by Lipella Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and tolerability of two doses of LP08 compared to placebo. Hypothesis: Safety of the LP-08 therapy will not be significantly different from the placebo group. Secondary Efficacy Endpoints: A matched-pair data analysis design will be employed, i.e. the measured outcomes will be subjects' improvements in quantitative and qualitative measures of the disease condition being assessed prior to and after LP-08 instillations at four and eight weeks follow-up visits
Interventions
- DRUG Normal saline
- DRUG LP-08 80mg
- DRUG LP-08 20mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2015-07-21 |
| Est. Completion | 2018-06-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01393223
The ClinicalTrials.gov registry entry for NCT01393223 describes a study currently listed as completed, categorized as Phase 2. 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 Lipella Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Normal saline is the first listed.
NCT01393223 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01393223 about?
NCT01393223 is a clinical study titled "Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome". The purpose of this study is to assess the safety and tolerability of two doses of LP08 compared to placebo. Hypothesis: Safety of the LP-08 therapy will not be significantly different from the placebo group. Secondary Efficacy Endpoints: A matched-pair data analysis design will be employed, i.e. th...
What is the current status of trial NCT01393223?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2015-07-21. Estimated completion is 2018-06-14.
What interventions are being tested in trial NCT01393223?
The interventions under investigation include: Normal saline (DRUG), LP-08 80mg (DRUG), LP-08 20mg (DRUG).
Who is sponsoring clinical trial NCT01393223?
This trial is sponsored by Lipella Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
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