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

Interstitial Cystitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01475253
• Other study ID #: TAR-100-201
• Status: Terminated
• Phase: Phase 2
• First received: November 3, 2011
• Last updated: August 19, 2015
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

Drug:
• Lidocaine Releasing Intravesical System - LiRIS®
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.

Other:
• LiRIS Placebo
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.

Procedure:
• Sham Cystoscopy Procedure
Cystoscopy procedure only; no investigational product is inserted/removed from the bladder.

Locations

Country	Name	City	State
Canada	Centre for Applied Urologic Research/Kingston General Hospital	Kingston	Ontario
Canada	Pacific Urological Research	Victoria	British Columbia
United States	Manatee Medical Research Institute, LLC	Bradenton	Florida
United States	Lahey Clinic Medical Center	Burlington	Massachusetts
United States	Medical University of South Carolina Urology Ambulatory Care	Charleston	South Carolina
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	North Idaho Urology	Coeur D'Alene	Idaho
United States	Genitourinary Surgical Consultants	Denver	Colorado
United States	Women's Health Specialty Care	Farmington	Connecticut
United States	Clinical Trials of Arizona	Glendale	Arizona
United States	Citrus Valley Medical Research, Inc	Glendora	California
United States	Female Pelvic Medicine & Urogynecology	Grand Rapids	Michigan
United States	Alliance Urology Specialists	Greensboro	North Carolina
United States	CRC of Jackson and Southeast Urogynecology	Jackson	Mississippi
United States	First Urology	Jeffersonville	Indiana
United States	Sheldon Freedman, MD Ltd	Las Vegas	Nevada
United States	Idaho Urologic Center	Meridian	Idaho
United States	Integrity Medical Research	Mountlake Terrace	Washington
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Grove Hill Clinical Research	New Britain	Connecticut
United States	Arthur Smith Institute for Urology	New Hyde Park	New York
United States	Penn. Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	University of Rochester, Department of Urology	Rochester	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Regional Urology LLC	Shreveport	Louisiana
United States	Stanford University Department of Urology	Stanford	California
United States	Bay State Clinical Trials, Inc	Watertown	Massachusetts
United States	Wake Forest University Health Sciences Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Allergan	TARIS Biomedical, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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.	Baseline, Days 7, 14, 28 and 42	No
Secondary	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.	Baseline, Days 7, 14, 28 and 42	No
Secondary	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.	Baseline, Days 7, 14, 28 and 42	No
Secondary	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	Baseline, Days 7, 14, 28 and 42	No
Secondary	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.	Baseline, Days 7, 14, 28 and 42	No
Secondary	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.	Baseline, Day 14	No