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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: Completed Phase 2 study, sponsored by Lipella Pharmaceuticals.
NCT01393223 is a Phase 2 study that has completed, run by Lipella Pharmaceuticals. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The number/severity of adverse events throughout the study
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 |
What the finished NCT01393223 record still lists
NCT01393223 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 3 interventions - of which Normal saline is the first listed.
NCT01393223 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01393223's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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