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Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis

NCT01475253 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2015-09-21

Study results available
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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.

Conditions

  • Interstitial Cystitis

Interventions

DRUG

Lidocaine Releasing Intravesical System - LiRIS®

Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period.

OTHER

LiRIS Placebo

LiRIS Placebo contains inactive substance only; LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.

PROCEDURE

Sham Cystoscopy Procedure

Cystoscopy procedure only; no investigational product is inserted/removed from the bladder.

Sponsors & Collaborators

  • TARIS Biomedical, Inc.

    collaborator INDUSTRY

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Curtis Nickel, MD · Queen's University/Kingston General Hospital/Ontario Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01475253 on ClinicalTrials.gov