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Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis

NCT01824303 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2016-01-26

Study results available
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Summary

The purposes of the study is to determine if LiRIS®, an investigational drug-delivery system, is safe and tolerable in women with Interstitial Cystitis (IC), and to evaluate any change in IC symptoms following LiRIS administration.

Conditions

  • Interstitial Cystitis

Interventions

DRUG

LiRIS 400 mg

LiRIS 400 mg contains lidocaine which is gradually released into the bladder over 14 days.

OTHER

LiRIS Placebo

LiRIS Placebo contains lactose, inactive substance.

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
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-11-30
Completion
2014-12-31

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 NCT01824303 on ClinicalTrials.gov