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

Primary Purpose

Cystitis, Interstitial, Ulcer

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 with Hunner's lesions/ulcers

Exclusion Criteria:

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

Sites / Locations

  • Tri Valley Urology Medical Group
  • Sutter Institute for Medical Research
  • Women's Health Specialty Care
  • Atlanta Medical Research Institute
  • Anne Arundel Urology, P.A.
  • Chesapeake Urology Research Associates
  • Beyer Research
  • Beaumont Health System
  • Washington University School of Medicine Department of Surgery
  • Western New York Urology Associates, LLC
  • McKay Urology
  • Eastern Urological Associates, PA
  • Wake Forest Baptist Health
  • MetroHealth System/Center for Advanced Gynecology
  • Philadelphia Urosurgical Associates
  • University of Washington
  • Aurora Health Care
  • Silverado Research Inc
  • Sunnybrook Health Science Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2)

LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)

LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS)
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.

Secondary Outcome Measures

Change From Baseline in the Number of Hunner's Lesions
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.
Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions
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.

Full Information

First Posted
March 17, 2015
Last Updated
September 5, 2018
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02395042
Brief Title
A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 15, 2015 (Actual)
Primary Completion Date
June 29, 2017 (Actual)
Study Completion Date
November 20, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystitis, Interstitial, Ulcer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)
Arm Type
Experimental
Arm Description
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.
Arm Title
LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
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
Drug
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 the Daily Average Bladder Pain Numeric Rating Scale (NRS)
Description
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.
Time Frame
Baseline (Day -7 to Day 0) to Week 4
Secondary Outcome Measure Information:
Title
Change From Baseline in the Number of Hunner's Lesions
Description
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.
Time Frame
Baseline (Day 0) to Week 4
Title
Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions
Description
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.
Time Frame
Baseline (Day 1) to 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 with Hunner's lesions/ulcers Exclusion Criteria: Previous treatment with LiRIS® Interstitial cystitis/bladder pain syndrome, without Hunner's lesions/ulcers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Till Geib
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Tri Valley Urology Medical Group
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Sutter Institute for Medical Research
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
Atlanta Medical Research Institute
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
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
Beaumont Health System
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Washington University School of Medicine Department of Surgery
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Western New York Urology Associates, LLC
City
Cheektowaga
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Facility Name
McKay Urology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
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 Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
MetroHealth System/Center for Advanced Gynecology
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Philadelphia Urosurgical Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Aurora Health Care
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
Facility Name
Silverado Research Inc
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 2C1
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

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

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