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

December 6, 2017 updated by: Allergan

A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating Safety and Efficacy of LiRIS® 400 mg in Females With Interstitial Cystitis/Bladder Pain Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

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
      • Kitchener, Ontario, Canada, N2N 2B9
        • Urology Associates/Urologic Medical Research
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Science Centre
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research, Inc.
    • California
      • Escondido, California, United States, 92025
        • IC Study LLC
      • Los Angeles, California, United States, 90048
        • Tower Urology
      • Murrieta, California, United States, 92562
        • Tri Valley Urology Medical Group
      • San Diego, California, United States, 92123
        • Genesis Research LLC
      • Vacaville, California, United States, 95688
        • Sutter Health
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Women's Health Specialty Care
      • New Haven, Connecticut, United States, 06519
        • Yale University
    • Florida
      • Bradenton, Florida, United States, 34205
        • Manatee Medical Research Institute
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Atlanta Medical Research Instititute
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Idaho Urologic Institute
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Associated Surgeons and Physicians LLC DBA Women's Health Advantage
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology, LLC
    • 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
        • William Beaumont Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
      • Saint Louis, Missouri, United States, 63117
        • Saint Louis University School of Medicine Department of Obstetrics, Gynecology, and Women's Health Division of Research
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Cooper University Hospita/ Univeristy Urogynecology Associates
    • New York
      • Cheektowaga, New York, United States, 14225
        • Western New York Urology Associates
      • Lake Success, New York, United States, 11042
        • BRANY, as agent The Arthur Smith Institute for North Shore Long Island Jewish Health System
      • Plainview, New York, United States, 11803
        • Urology Institute of Long Island
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • McKay Urology
      • Greensboro, North Carolina, United States, 27403
        • Alliance Urology Specialist, P.A.
      • Greenville, North Carolina, United States, 27834
        • Eastern Urological Associates, PA
      • Winston-Salem, North Carolina, United States, 27103
        • Wake Forest University
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth System
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Female Sexual and Pelvic Health Institute
    • Washington
      • Mountlake Terrace, Washington, United States, 98043
        • Integrity Medical Research (Urology Northwest)
      • Seattle, Washington, United States, 98195
        • University of Washington

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosis of interstitial cystitis or bladder pain syndrome

Exclusion Criteria:

  • Diagnosis of interstitial cystitis with Hunner's lesions/ulcers
  • Previous treatment with LiRIS®

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)
Treatment Period 1: continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
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.
OTHER: LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)
Treatment period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up
Time Frame: Baseline (Days -7 to 0) to Treatment 1 Week 4
The participant recorded their bladder pain over the previous 24-hour period in a 7-day pain assessment tool using an 11-point Numeric Rating Scale (NRS) (0 to 10) where 0=no pain to 10= worst pain. Pain data recorded 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 factors (age group: < 40 years or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or > 6) as factors was used for analysis.
Baseline (Days -7 to 0) to Treatment 1 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

Helpful Links

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)

May 21, 2015

Primary Completion (ACTUAL)

October 12, 2016

Study Completion (ACTUAL)

January 9, 2017

Study Registration Dates

First Submitted

April 3, 2015

First Submitted That Met QC Criteria

April 3, 2015

First Posted (ESTIMATE)

April 8, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 4, 2018

Last Update Submitted That Met QC Criteria

December 6, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201025-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

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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