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

This study has been terminated.
(This study was not enrolled completely and was terminated.)
Sponsor:
Collaborator:
TARIS Biomedical, Inc.
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01475253
First received: November 3, 2011
Last updated: August 19, 2015
Last verified: August 2015
  Purpose
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.

Condition Intervention Phase
Interstitial Cystitis
Drug: Lidocaine Releasing Intravesical System - LiRIS®
Other: LiRIS Placebo
Procedure: Sham Cystoscopy Procedure
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7 [ Time Frame: Baseline, Day 7 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Day 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Day 42 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, Days 7, 14, 28 and 42 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Days 7, 14, 28 and 42 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Days 7, 14, 28 and 42 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Days 7, 14, 28 and 42 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Days 7, 14, 28 and 42 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
    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.


Enrollment: 104
Study Start Date: November 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine Releasing Intravesical System
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.
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 Names:
  • LiRIS® 400 mg
  • LiRIS® 400 mg (Active)
Placebo Comparator: LiRIS containing inactive substance only
LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.
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.
Other Name: LiRIS® 400 mg Placebo
Sham Comparator: Cystoscopy Procedure
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.
Procedure: Sham Cystoscopy Procedure
Cystoscopy procedure only; no investigational product is inserted/removed from the bladder.
Other Names:
  • Sham Comparator
  • Sham arm

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475253

  Show 29 Study Locations
Sponsors and Collaborators
Allergan
TARIS Biomedical, Inc.
Investigators
Principal Investigator: Curtis Nickel, MD Queen's University/Kingston General Hospital/Ontario Canada
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01475253     History of Changes
Other Study ID Numbers: TAR-100-201 
Study First Received: November 3, 2011
Results First Received: August 5, 2014
Last Updated: August 19, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Cystitis, Interstitial
Cystitis
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

ClinicalTrials.gov processed this record on July 27, 2016