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

September 5, 2018 updated by: Allergan

A Multicenter, Randomized, Double-blind, Placebo-controlled Study, Evaluating Safety and Efficacy of LiRIS® 400 mg in Females With Interstitial Cystitis With Hunner's Lesions

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8T 2C1
        • Silverado Research Inc
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Science Centre
  • United States
    • California
      • Murrieta, California, United States, 92562
        • Tri Valley Urology Medical Group
      • Vacaville, California, United States, 95688
        • Sutter Institute for Medical Research
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Women's Health Specialty Care
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Atlanta Medical Research Institute
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Urology, P.A.
      • Baltimore, Maryland, United States, 21237
        • Chesapeake Urology Research Associates
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Beyer Research
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Health System
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine Department of Surgery
    • New York
      • Cheektowaga, New York, United States, 14214
        • Western New York Urology Associates, LLC
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • McKay Urology
      • Greenville, North Carolina, United States, 27834
        • Eastern Urological Associates, PA
      • Winston-Salem, North Carolina, United States, 27103
        • Wake Forest Baptist Health
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth System/Center for Advanced Gynecology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Philadelphia Urosurgical Associates
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
    • Wisconsin
      • West Allis, Wisconsin, United States, 53227
        • Aurora Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosis of interstitial cystitis with Hunner's lesions/ulcers

Exclusion Criteria:

  • Previous treatment with LiRIS®
  • Interstitial cystitis/bladder pain syndrome, without Hunner's lesions/ulcers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2)
Treatment 1 Period (Tx 1): Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period (Tx 2): optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.
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.
Experimental: LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)
Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.
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
Experimental: LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS)
Time Frame: Baseline (Day -7 to Day 0) to Week 4
The participant recorded their daily bladder pain score over the previous 24-hour period on a 7-day pain assessment tool as measured by an NRS on an 11-point scale where 0=no pain to 10=worst pain imaginable. The daily pain scores over the 7-day period were averaged. A negative change from Baseline indicates improvement. An analysis of covariance (ANCOVA) model with Baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors was used for analysis.
Baseline (Day -7 to Day 0) to Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Number of Hunner's Lesions
Time Frame: Baseline (Day 0) to Week 4
During each cystoscopy, the investigator counted the number of lesions visible while performing the bladder scan. A negative change from Baseline indicates improvement (less lesions). An ANCOVA model with Baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors was used for analysis.
Baseline (Day 0) to Week 4
Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions
Time Frame: Baseline (Day 1) to Week 4
A standardized video capture protocol for bladder mapping was followed to assess any changes in the number, the size and the severity, of lesions during the study as a result of treatment. A negative change from Baseline indicates improvement.
Baseline (Day 1) to Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2015

Primary Completion (Actual)

June 29, 2017

Study Completion (Actual)

November 20, 2017

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Actual)

October 5, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201025-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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