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A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome

NCT02411110 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2018-01-04

Study results available
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Summary

This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder pain syndrome.

Conditions

  • Cystitis, Interstitial
  • Painful Bladder Syndrome

Interventions

COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

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
2015-05-21
Primary Completion
2016-10-12
Completion
2017-01-09
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

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 NCT02411110 on ClinicalTrials.gov