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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Interstitial Cystitis

In brief

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.

Key facts

Study ID

NCT01824303

Run by

Allergan

People needed

31

Starts

2013-03-01

Expected to finish

2014-12-01

Last updated by the study team

2016-01-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Citrus Valley Medical Research , Inc. — Glendora, California, United States
• Atlantic Urological Associates — Daytona Beach, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• The UrogynecologyCenter, LLC — Overland Park, Kansas, United States
• Female Pelvic Medicine & Urogynecology Institute of MI — Grand Rapids, Michigan, United States
• William Beaumont Hospitals — Royal Oak, Michigan, United States
• North Shore - Long Island Jewish Heath System - Monter Cancer Center — New Hyde Park, New York, United States
• Premier Medical Group of the Hudson Valley PC — Newburgh, New York, United States
• Premier Medical Group of the Hudson Valley PC — Poughkeepsie, New York, United States
• Alliance Urology Specialists, PA — Greensboro, North Carolina, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Volunteer Research Group, University of Tennessee Medical Center — Knoxville, Tennessee, United States
• Exdeo Clinical Research Inc. — Abbotsford British Columbia, British Columbia, Canada
• Centre for Applied Urological Research — Kingston, Ontario, Canada

Full record on ClinicalTrials.gov

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