Safety, Tolerability and Efficacy Study of LiRIS® 400mg in Women With Interstitial Cystitis

This study is currently recruiting participants.
Verified November 2013 by TARIS Biomedical, Inc.
Sponsor:
Information provided by (Responsible Party):
TARIS Biomedical, Inc.
ClinicalTrials.gov Identifier:
NCT01824303
First received: March 31, 2013
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

The purposes of the study is to determine if LiRIS®, an investigational drug-delivery system, is safe and tolerable in women with Interstitial Cystitis (IC), and to evaluate any change in IC symptoms following LiRIS administration.


Condition Intervention Phase
Interstitial Cystitis
Drug: LiRIS 400 mg
Other: LiRIS Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® 400 mg in Women With Interstitial Cystitis Followed by an Open Label Extension

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in subject reported bladder pain on a numerical rating scale [ Time Frame: Study Days 10 through12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Study Start Date: March 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LiRIS 400 mg
LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days
Drug: LiRIS 400 mg
LiRIS 400 mg contains lidocaine which is gradually released into the bladder over 14 days.
Placebo Comparator: LiRIS Placebo
LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
Other: LiRIS Placebo
LiRIS Placebo contains lactose, inactive substance.

Detailed Description:

The study is conducted in 2 parts: a randomized, blinded part in which subjects are assigned randomly (by chance) to LiRIS 400 mg or LiRIS placebo; subjects who complete this part and are eligible to continue,may participate in the open-label part in which all subjects receive LiRIS 400mg.

In both parts of the study (blinded and open-label), LiRIS is inserted into the bladder during cystoscopy, remains in the bladder for 14 days, and is removed during cystoscopy. In addition to the 14 day period with the LiRIS/LiRIS Placebo, there is a screening period of up to 2 weeks and a follow up period of 4 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Blinded study:

  • Women age 18 and over
  • Diagnosed with Interstitial Cystitis as defined by protocol
  • Able to report IC symptoms of bladder pain, voiding habits, as required by protocol, and record in diary
  • Able to comply with visit schedule and diary completion at home

Open-label Extension:

  • Must have completed the blinded study prior to screening for the Open-label extension

Exclusion Criteria(Blinded and Open-Label Extension):

  • Pregnant or lactating women
  • History or presence of any condition that would make it difficult to accurately evaluate bladder symptoms
  • Bladder or urethral abnormality that would prevent safe insertion of investigational product
  • Requiring medication not allowed per study protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01824303

Locations
United States, California
Citrus Valley Medical Research , Inc. Recruiting
Glendora, California, United States, 91741
Contact: Lisa Regan    626-914-3295      
Contact: Robin Metzger    626-914-3295      
Stanford University Not yet recruiting
Stanford, California, United States, 94305
Contact: Anna Ramakrishnan    650-498-4240      
United States, Indiana
First Urology, PSC Recruiting
Jeffersonville, Indiana, United States, 47130
Contact: Christina Dallas    812-206-8164      
United States, Michigan
Female Pelvic Medicine & Urogynecology Institute of MI Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Beth Rogers    588-616-1135      
William Beaumont Hospitals Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Maureen Cooney, RN    248-551-9477      
United States, New York
Arthur Smith Institute of Urology Recruiting
New Hyde Park, New York, United States, 11040
Contact: Monica Johnson, RN    516-734-8515      
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Betty Smith    585-275-2486      
United States, North Carolina
Alliance Urology Specialists, PA Recruiting
Greensboro, North Carolina, United States, 27403
Contact: Michelle Utrera    336-232-5322      
Wake Forest Baptist Health Not yet recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Janet Shuping    336-716-2612      
United States, Ohio
The Urology Group Recruiting
Cincinnati, Ohio, United States, 45212
Contact: Pam Ervin    513-841-7550      
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Anna McGrail    216-778-8432      
Contact: Marilyn Alejandro-Rodriquez    216-778-8432      
United States, Oklahoma
Urologic Specialists Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Susan Sossamon    918-392-2196      
United States, South Carolina
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Jennifer Baiden    843-449-1010 ext 237      
United States, Washington
Integrity Medical Research Recruiting
Mountlake Terrace, Washington, United States, 98043
Contact: Anna Fierro    425-275-0680      
Canada, Ontario
Centre for Applied Urological Research Recruiting
Kingston, Ontario, Canada, K7L 3J7
Contact: Sylvia Robb    613 548 7800      
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: NCT01824303     History of Changes
Other Study ID Numbers: TAR-100-202
Study First Received: March 31, 2013
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014