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A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions

NCT02395042 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2018-10-05

Study results available
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Summary

This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with Hunner's lesions.

Conditions

  • Cystitis, Interstitial
  • Ulcer

Interventions

DRUG

LiRIS®

LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy.

DRUG

LiRIS Placebo

LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Till Geib · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-15
Primary Completion
2017-06-29
Completion
2017-11-20

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 NCT02395042 on ClinicalTrials.gov