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Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis

Primary Purpose

Interstitial Cystitis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lidocaine Releasing Intravesical System - LiRIS®
LiRIS Placebo
Sham Cystoscopy Procedure
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Clinical Trials of Arizona
  • Citrus Valley Medical Research, Inc
  • Stanford University Department of Urology
  • Genitourinary Surgical Consultants
  • Women's Health Specialty Care
  • Grove Hill Clinical Research
  • Manatee Medical Research Institute, LLC
  • North Idaho Urology
  • Idaho Urologic Center
  • First Urology
  • Regional Urology LLC
  • Lahey Clinic Medical Center
  • Bay State Clinical Trials, Inc
  • Female Pelvic Medicine & Urogynecology
  • William Beaumont Hospital
  • CRC of Jackson and Southeast Urogynecology
  • Sheldon Freedman, MD Ltd
  • Arthur Smith Institute for Urology
  • University of Rochester, Department of Urology
  • Alliance Urology Specialists
  • Wake Forest University Health Sciences Medical Center
  • MetroHealth Medical Center
  • Penn. Presbyterian Medical Center
  • Medical University of South Carolina Urology Ambulatory Care
  • Carolina Urologic Research Center
  • Vanderbilt University Medical Center
  • Integrity Medical Research
  • Pacific Urological Research
  • Centre for Applied Urologic Research/Kingston General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Sham Comparator

Arm Label

Lidocaine Releasing Intravesical System

LiRIS containing inactive substance only

Cystoscopy Procedure

Arm Description

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 is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.

No 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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Percentage of Responders Using the Global Response Assessment (GRA)
Participants assessed their response to treatment using a seven item scale from Markedly improved to Markedly worse. A responder was defined as a participant who rated their symptoms as either Moderately or Markedly improved.
Change From Baseline in Urinary Urgency as Assessed by VAS
Urinary urgency was defined as an immediate unstoppable urge to urinate which may be due to a sudden involuntary contraction of the muscular wall of the bladder and may be accompanied by discomfort in the bladder. Participants reported symptom of urinary urgency in the last 24 hours using a Urgency Visual Analogue Scale (VAS). The Urgency VAS consists of a 10 centimeter (cm) horizontal line with the words "No Urgency" (best) at the left end (0 cm) and the words "Urgency as bad as you can imagine" (worst) at the right end (10 cm). Participants were instructed to complete the Pain VAS by marking the spot on the line that corresponded to their urinary urgency. A negative change from Baseline indicates improvement.
Change From Baseline in Voiding Frequency
Participants recorded Voiding Frequency in a 72 hour voiding log at Day 7, 14, 28 and 42. Lower numbers of voiding frequency is the best. A negative change from Baseline indicates improvement.
Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
Participants answered four questions about bladder/voiding symptoms over the past month. 2 questions were on a scale of 0=Not at all to 5=Almost always, 1 question on a scale of 0=Not at all to 5=5 or more times per night and 1 questions from 0=Not at all to 4=Almost always for a total possible score of 0 (best) to19 (worst). A negative change from Baseline indicates improvement
Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score
Participants answered four questions about how bothersome their symptoms were over the past month using a 5 point scale: 1=No problem to 4=Big problem for a total possible score of 0 (best) to 16 worst). A negative change from Baseline indicates improvement.
Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings
Cystoscopic examinations were performed at Baseline and Day 14. The investigator assessed the urethra and bladder for the following: visibility of ureters, stricture, erythema, presence and number of Hunner's lesion(s) and the extent of erythema. For sites with the capability, videography or high resolution digital photographs of the bladder were taken. The findings at Day 14 were compared to the findings at Baseline and were reported as Improvement, Worsening or No Change.

Full Information

First Posted
November 3, 2011
Last Updated
August 19, 2015
Sponsor
Allergan
Collaborators
TARIS Biomedical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01475253
Brief Title
Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
This study was not enrolled completely and was terminated.
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
Collaborators
TARIS Biomedical, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The study is conducted in 2 parts - a randomized, blinded part in which patients are randomly assigned to one of 3 possible arms (LiRIS® - contains lidocaine), LiRIS Placebo (LiRIS with inactive substance) or Sham(Insertion procedure only with neither LiRIS nor LiRIS Placebo), followed by an open extension part in which all patients are assigned to receive LiRIS® (with lidocaine). In part 1 of the study, treatment is managed in a double-blind manner for LiRIS® and LiRIS Placebo arms; and in a single-blind manner for the Sham arm (e.g.,the study doctor will know the treatment assignment for patients assigned to Sham). All patients who complete part 1 of the study have the option to enter the extension.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine Releasing Intravesical System
Arm Type
Experimental
Arm Description
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.
Arm Title
LiRIS containing inactive substance only
Arm Type
Placebo Comparator
Arm Description
LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.
Arm Title
Cystoscopy Procedure
Arm Type
Sham Comparator
Arm Description
No 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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine Releasing Intravesical System - LiRIS®
Other Intervention Name(s)
LiRIS® 400 mg, LiRIS® 400 mg (Active)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
LiRIS Placebo
Other Intervention Name(s)
LiRIS® 400 mg Placebo
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham Cystoscopy Procedure
Other Intervention Name(s)
Sham Comparator, Sham arm
Intervention Description
Cystoscopy procedure only; no investigational product is inserted/removed from the bladder.
Primary Outcome Measure Information:
Title
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7
Description
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.
Time Frame
Baseline, Day 7
Title
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14
Description
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.
Time Frame
Baseline, Day 14
Title
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28
Description
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.
Time Frame
Baseline, Day 28
Title
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42
Description
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.
Time Frame
Baseline, Day 42
Secondary Outcome Measure Information:
Title
Percentage of Responders Using the Global Response Assessment (GRA)
Description
Participants assessed their response to treatment using a seven item scale from Markedly improved to Markedly worse. A responder was defined as a participant who rated their symptoms as either Moderately or Markedly improved.
Time Frame
Baseline, Days 7, 14, 28 and 42
Title
Change From Baseline in Urinary Urgency as Assessed by VAS
Description
Urinary urgency was defined as an immediate unstoppable urge to urinate which may be due to a sudden involuntary contraction of the muscular wall of the bladder and may be accompanied by discomfort in the bladder. Participants reported symptom of urinary urgency in the last 24 hours using a Urgency Visual Analogue Scale (VAS). The Urgency VAS consists of a 10 centimeter (cm) horizontal line with the words "No Urgency" (best) at the left end (0 cm) and the words "Urgency as bad as you can imagine" (worst) at the right end (10 cm). Participants were instructed to complete the Pain VAS by marking the spot on the line that corresponded to their urinary urgency. A negative change from Baseline indicates improvement.
Time Frame
Baseline, Days 7, 14, 28 and 42
Title
Change From Baseline in Voiding Frequency
Description
Participants recorded Voiding Frequency in a 72 hour voiding log at Day 7, 14, 28 and 42. Lower numbers of voiding frequency is the best. A negative change from Baseline indicates improvement.
Time Frame
Baseline, Days 7, 14, 28 and 42
Title
Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
Description
Participants answered four questions about bladder/voiding symptoms over the past month. 2 questions were on a scale of 0=Not at all to 5=Almost always, 1 question on a scale of 0=Not at all to 5=5 or more times per night and 1 questions from 0=Not at all to 4=Almost always for a total possible score of 0 (best) to19 (worst). A negative change from Baseline indicates improvement
Time Frame
Baseline, Days 7, 14, 28 and 42
Title
Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score
Description
Participants answered four questions about how bothersome their symptoms were over the past month using a 5 point scale: 1=No problem to 4=Big problem for a total possible score of 0 (best) to 16 worst). A negative change from Baseline indicates improvement.
Time Frame
Baseline, Days 7, 14, 28 and 42
Title
Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings
Description
Cystoscopic examinations were performed at Baseline and Day 14. The investigator assessed the urethra and bladder for the following: visibility of ureters, stricture, erythema, presence and number of Hunner's lesion(s) and the extent of erythema. For sites with the capability, videography or high resolution digital photographs of the bladder were taken. The findings at Day 14 were compared to the findings at Baseline and were reported as Improvement, Worsening or No Change.
Time Frame
Baseline, Day 14

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curtis Nickel, MD
Organizational Affiliation
Queen's University/Kingston General Hospital/Ontario Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trials of Arizona
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Citrus Valley Medical Research, Inc
City
Glendora
State/Province
California
ZIP/Postal Code
91741
Country
United States
Facility Name
Stanford University Department of Urology
City
Stanford
State/Province
California
ZIP/Postal Code
94306
Country
United States
Facility Name
Genitourinary Surgical Consultants
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Women's Health Specialty Care
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Grove Hill Clinical Research
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
Manatee Medical Research Institute, LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
North Idaho Urology
City
Coeur D'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Idaho Urologic Center
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
First Urology
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Regional Urology LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Lahey Clinic Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Bay State Clinical Trials, Inc
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Female Pelvic Medicine & Urogynecology
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
CRC of Jackson and Southeast Urogynecology
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Sheldon Freedman, MD Ltd
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Arthur Smith Institute for Urology
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
University of Rochester, Department of Urology
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Alliance Urology Specialists
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Wake Forest University Health Sciences Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Penn. Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina Urology Ambulatory Care
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Integrity Medical Research
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
Facility Name
Pacific Urological Research
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3N1
Country
Canada
Facility Name
Centre for Applied Urologic Research/Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3J7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis

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