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Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS in Women With Interstitial Cystitis, Followed by Open-label Extension

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
TARIS Biomedical, Inc.
ClinicalTrials.gov Identifier:
NCT01475253
First received: November 3, 2011
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  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
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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:

U.S. FDA Resources

Further study details as provided by TARIS Biomedical, Inc.:

Primary Outcome Measures:
  • Symptom Scores: Pain Visual Analog Scale (VAS) [ Time Frame: At defined timepoints during the 2 week treatment and 4 week follow up period ] [ Designated as safety issue: No ]
    The patient completes the VAS assessment of bladder pain.


Secondary Outcome Measures:
  • Overall symptoms: Global Response Assessment (GRA);Interstitial Cystitis Symptom and Problem Index (ICSI and ICPI); voiding frequency [ Time Frame: At defined timepoints during 2 week treatment and 4 week follow up period ] [ Designated as safety issue: Yes ]
    The patient completes the GRA,Urgency VAS, ICSI/ICPI questionnaire, and Voiding Log


Enrollment: 104
Study Start Date: November 2011
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine Releasing Intravesical System - LiRIS®
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®
Drug-delivery system remains in the bladder for up to 2 weeks and releases lidocaine over 2 week period
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.
Sham Comparator: Cystoscopy Procedure
Cystoscopy procedure is performed on study Day 0 and study Day 14; no Investigational Product is inserted into the bladder.
 Procedure: Sham
Cystoscopy procedure only; no investigational product is inserted/removed from the bladder.

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

  Show 30 Study Locations
Sponsors and Collaborators
TARIS Biomedical, Inc.
Investigators
Principal Investigator: Curtis Nickel, MD Queen's University/Kingston General Hospital/Ontario Canada
  More Information

No publications provided

Responsible Party: TARIS Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT01475253     History of Changes
Other Study ID Numbers: TAR-100-201
Study First Received: November 3, 2011
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013