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Safety Study of LiRIS in Interstitial Cystitis (IC) Patients

NCT01150565 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2014-11-25

No results posted yet for this study

Summary

The purpose of this study is primarily to evaluate the safety and tolerability of two dose levels of an investigational drug-delivery system (LiRIS) in patients who have moderate to severe symptoms of interstitial cystitis.

Conditions

  • Interstitial Cystitis

Interventions

DRUG

LiRIS low dose and LiRIS high dose

Drug delivery system containing lidocaine; LiRIS (low or high dose) is inserted into bladder via cystoscopy on Day 1 and removed via cystoscopy on Day 14. Designed to release lidocaine over a 14 day period.

Sponsors & Collaborators

  • TARIS Biomedical, Inc.

    collaborator INDUSTRY

  • Allergan

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • 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 NCT01150565 on ClinicalTrials.gov