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Trial record 85 of 158 for:    interstitial cystitis

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

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ClinicalTrials.gov Identifier: NCT02395042
Recruitment Status : Completed
First Posted : March 20, 2015
Results First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment Phase
Cystitis, Interstitial Ulcer Drug: LiRIS® Drug: LiRIS Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 15, 2015
Actual Primary Completion Date : June 29, 2017
Actual Study Completion Date : November 20, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395042


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

Documents provided by Allergan:
Study Protocol  [PDF] April 28, 2016
Statistical Analysis Plan  [PDF] March 27, 2018


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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02395042     History of Changes
Other Study ID Numbers: 201025-001
First Posted: March 20, 2015    Key Record Dates
Results First Posted: October 5, 2018
Last Update Posted: October 5, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action