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NCT01475253 · ClinicalTrials.gov registry record · Phase 2
Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis
A Phase 2 study, sponsored by Allergan.
- Terminated
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
NCT01475253: Clinical Trial Phase 2 study, sponsored by Allergan.
NCT01475253 is a Phase 2 study that was terminated before completion, run by Allergan. The registered enrollment target is 104 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01475253, a Phase 2 study, was terminated before completion, sponsored by Allergan.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy.
Primary Outcome
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter (cm) horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Interventions
- OTHER LiRIS Placebo
- DRUG Lidocaine Releasing Intravesical System - LiRIS®
- PROCEDURE Sham Cystoscopy Procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
Why NCT01475253 stopped before completion
NCT01475253 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 3 interventions - of which LiRIS Placebo is the first listed.
NCT01475253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01475253 about?
NCT01475253 is a clinical study titled "Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis". The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy.
What is the current status of trial NCT01475253?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2011-11. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01475253?
The interventions under investigation include: LiRIS Placebo (OTHER), Lidocaine Releasing Intravesical System - LiRIS® (DRUG), Sham Cystoscopy Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT01475253?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01475253's enrollment target sits among peer trials
104 660th of 2000 higher than 1,337 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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