Study Stopped
This study was not enrolled completely and was terminated.
Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis
A Phase 2a Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® in Women With Interstitial Cystitis Followed by an Open Label Extension
1 other identifier
interventional
104
2 countries
29
Brief Summary
The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2011
Shorter than P25 for phase_2
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 3, 2011
CompletedFirst Posted
Study publicly available on registry
November 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
September 21, 2015
CompletedSeptember 21, 2015
August 1, 2015
1.1 years
November 3, 2011
August 5, 2014
August 19, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter (cm) horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Baseline, Day 7
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Baseline, Day 14
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Baseline, Day 28
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Baseline, Day 42
Secondary Outcomes (6)
Percentage of Responders Using the Global Response Assessment (GRA)
Baseline, Days 7, 14, 28 and 42
Change From Baseline in Urinary Urgency as Assessed by VAS
Baseline, Days 7, 14, 28 and 42
Change From Baseline in Voiding Frequency
Baseline, Days 7, 14, 28 and 42
Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
Baseline, Days 7, 14, 28 and 42
Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score
Baseline, Days 7, 14, 28 and 42
- +1 more secondary outcomes
Study Arms (3)
Lidocaine Releasing Intravesical System
EXPERIMENTALLidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period.
LiRIS containing inactive substance only
PLACEBO COMPARATORLiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.
Cystoscopy Procedure
SHAM COMPARATORNo intervention. Cystoscopy procedure is performed on study Day 0 and study Day 14 to mimick active and placebo study arms without insertion of Investigational Product into the bladder.
Interventions
Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period.
LiRIS Placebo contains inactive substance only; LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.
Cystoscopy procedure only; no investigational product is inserted/removed from the bladder.
Eligibility Criteria
You may qualify if:
- Women age 18 and over
- Diagnosed with Interstitial Cystitis as defined by protocol
- Able and willing to complete questionnaires and diary
- Able to comply with visit schedule including Day 14 Removal visit
- Completion of blinded study prior to enrolling in unblinded part of study
You may not qualify if:
- Pregnant or lactating women
- Bladder or urethra anatomical feature that would prevent the safe indwelling or insertion of the investigational product
- History or presence of any condition that would make it difficult to evaluate symptoms
- Did not complete blinded study (unblinded part of study only)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
- TARIS Biomedical, Inc.collaborator
Study Sites (29)
Clinical Trials of Arizona
Glendale, Arizona, 85306, United States
Citrus Valley Medical Research, Inc
Glendora, California, 91741, United States
Stanford University Department of Urology
Stanford, California, 94306, United States
Genitourinary Surgical Consultants
Denver, Colorado, 80220, United States
Women's Health Specialty Care
Farmington, Connecticut, 06032, United States
Grove Hill Clinical Research
New Britain, Connecticut, 06052, United States
Manatee Medical Research Institute, LLC
Bradenton, Florida, 34205, United States
North Idaho Urology
Coeur d'Alene, Idaho, 83814, United States
Idaho Urologic Center
Meridian, Idaho, 83642, United States
First Urology
Jeffersonville, Indiana, 47130, United States
Regional Urology LLC
Shreveport, Louisiana, 71106, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805, United States
Bay State Clinical Trials, Inc
Watertown, Massachusetts, 02472, United States
Female Pelvic Medicine & Urogynecology
Grand Rapids, Michigan, 49503, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
CRC of Jackson and Southeast Urogynecology
Jackson, Mississippi, 39202, United States
Sheldon Freedman, MD Ltd
Las Vegas, Nevada, 89148, United States
Arthur Smith Institute for Urology
New Hyde Park, New York, 11040, United States
University of Rochester, Department of Urology
Rochester, New York, 14642, United States
Alliance Urology Specialists
Greensboro, North Carolina, 27403, United States
Wake Forest University Health Sciences Medical Center
Winston-Salem, North Carolina, 27103, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Penn. Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina Urology Ambulatory Care
Charleston, South Carolina, 29425, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Integrity Medical Research
Mountlake Terrace, Washington, 98043, United States
Pacific Urological Research
Victoria, British Columbia, V8V 3N1, Canada
Centre for Applied Urologic Research/Kingston General Hospital
Kingston, Ontario, K7L 3J7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group. Only safety analyses were completed.
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Curtis Nickel, MD
Queen's University/Kingston General Hospital/Ontario Canada
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2011
First Posted
November 21, 2011
Study Start
November 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
September 21, 2015
Results First Posted
September 21, 2015
Record last verified: 2015-08