Trial record 14 of 32 for:    Open Studies | "Cystitis, Interstitial"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by TARIS Biomedical, Inc.
Sponsor:
Information provided by (Responsible Party):
TARIS Biomedical, Inc.
ClinicalTrials.gov Identifier:
NCT01824303
First received: March 31, 2013
Last updated: April 18, 2014
Last verified: April 2014
  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
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: 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, Florida
Atlantic Urological Associates Recruiting
Daytona Beach, Florida, United States, 32114
Contact: Jonelle Horsely    386-239-8535      
United States, Indiana
First Urology, PSC Withdrawn
Jeffersonville, Indiana, United States, 47130
United States, Kansas
The UrogynecologyCenter, LLC Recruiting
Overland Park, Kansas, United States, 66209-2002
Contact: Margo Sanford    913-307-0044 ext 9      
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 Withdrawn
Rochester, New York, United States, 14642
United States, North Carolina
Alliance Urology Specialists, PA Recruiting
Greensboro, North Carolina, United States, 27403
Contact: Lisa Bennett    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: Leslie Mahler    513-841-7554      
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 Withdrawn
Tulsa, Oklahoma, United States, 74146
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, Tennessee
Volunteer Research Group, University of Tennessee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Brandy Herbert    865-305-9100 ext 290      
United States, Washington
Integrity Medical Research Recruiting
Mountlake Terrace, Washington, United States, 98043
Contact: Anna Fierro    425-275-0680      
Canada, British Columbia
Exdeo Clinical Research Inc. Recruiting
Abbotsford, British Columbia, Canada, V2S 3N6
Contact: Mavis Ye    1-604-851-5667      
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: April 18, 2014
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 July 24, 2014