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

Primary Purpose

Cystitis, Interstitial, Painful Bladder Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LiRIS®
LiRIS Placebo
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystitis, Interstitial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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®

Sites / Locations

  • Coastal Clinical Research, Inc.
  • IC Study LLC
  • Tower Urology
  • Tri Valley Urology Medical Group
  • Genesis Research LLC
  • Sutter Health
  • Women's Health Specialty Care
  • Yale University
  • Manatee Medical Research Institute
  • Atlanta Medical Research Instititute
  • Idaho Urologic Institute
  • Associated Surgeons and Physicians LLC DBA Women's Health Advantage
  • Regional Urology, LLC
  • Anne Arundel Urology, P.A.
  • Chesapeake Urology Research Associates
  • Beyer Research
  • William Beaumont Hospital
  • Washington University
  • Saint Louis University School of Medicine Department of Obstetrics, Gynecology, and Women's Health Division of Research
  • Cooper University Hospita/ Univeristy Urogynecology Associates
  • Western New York Urology Associates
  • BRANY, as agent The Arthur Smith Institute for North Shore Long Island Jewish Health System
  • Urology Institute of Long Island
  • McKay Urology
  • Alliance Urology Specialist, P.A.
  • Eastern Urological Associates, PA
  • Wake Forest University
  • MetroHealth System
  • Female Sexual and Pelvic Health Institute
  • Integrity Medical Research (Urology Northwest)
  • University of Washington
  • Silverado Research Inc
  • Urology Associates/Urologic Medical Research
  • Sunnybrook Health Science Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)

LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up
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.

Secondary Outcome Measures

Full Information

First Posted
April 3, 2015
Last Updated
December 6, 2017
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02411110
Brief Title
A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating Safety and Efficacy of LiRIS® 400 mg in Females With Interstitial Cystitis/Bladder Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 21, 2015 (Actual)
Primary Completion Date
October 12, 2016 (Actual)
Study Completion Date
January 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystitis, Interstitial, Painful Bladder Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)
Arm Type
Experimental
Arm Description
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.
Arm Title
LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)
Arm Type
Other
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
LiRIS®
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
LiRIS Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up
Description
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.
Time Frame
Baseline (Days -7 to 0) to Treatment 1 Week 4

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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®
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Till Geib
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Coastal Clinical Research, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
IC Study LLC
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Tower Urology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Tri Valley Urology Medical Group
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Genesis Research LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sutter Health
City
Vacaville
State/Province
California
ZIP/Postal Code
95688
Country
United States
Facility Name
Women's Health Specialty Care
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Manatee Medical Research Institute
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Atlanta Medical Research Instititute
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Idaho Urologic Institute
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Associated Surgeons and Physicians LLC DBA Women's Health Advantage
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Anne Arundel Urology, P.A.
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Beyer Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Saint Louis University School of Medicine Department of Obstetrics, Gynecology, and Women's Health Division of Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Cooper University Hospita/ Univeristy Urogynecology Associates
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Western New York Urology Associates
City
Cheektowaga
State/Province
New York
ZIP/Postal Code
14225
Country
United States
Facility Name
BRANY, as agent The Arthur Smith Institute for North Shore Long Island Jewish Health System
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Urology Institute of Long Island
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
McKay Urology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Alliance Urology Specialist, P.A.
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Eastern Urological Associates, PA
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
MetroHealth System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Female Sexual and Pelvic Health Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Integrity Medical Research (Urology Northwest)
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Silverado Research Inc
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 2C1
Country
Canada
Facility Name
Urology Associates/Urologic Medical Research
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 2B9
Country
Canada
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
34288094
Citation
Evans R, Kohan A, Moldwin R, Radecki D, Geib T, Peters KM. Safety, tolerability, and efficacy of LiRIS 400 mg in women with interstitial cystitis/bladder pain syndrome with or without Hunner lesions. Neurourol Urodyn. 2021 Sep;40(7):1730-1739. doi: 10.1002/nau.24702. Epub 2021 Jul 20.
Results Reference
derived
Links:
URL
http://www.AllerganClinicalTrials.com
Description
Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, plesase contact IR-CTRegistration@Allergan.com for assistance.

Learn more about this trial

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

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