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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Interstitial Cystitis

In brief

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.

Key facts

Study ID

NCT01475253

Run by

Allergan

People needed

104

Starts

2011-11-01

Expected to finish

2012-12-01

Last updated by the study team

2015-09-21

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Clinical Trials of Arizona — Glendale, Arizona, United States
• Citrus Valley Medical Research, Inc — Glendora, California, United States
• Stanford University Department of Urology — Stanford, California, United States
• Genitourinary Surgical Consultants — Denver, Colorado, United States
• Women's Health Specialty Care — Farmington, Connecticut, United States
• Grove Hill Clinical Research — New Britain, Connecticut, United States
• Manatee Medical Research Institute, LLC — Bradenton, Florida, United States
• North Idaho Urology — Coeur d'Alene, Idaho, United States
• Idaho Urologic Center — Meridian, Idaho, United States
• First Urology — Jeffersonville, Indiana, United States
• Regional Urology LLC — Shreveport, Louisiana, United States
• Lahey Clinic Medical Center — Burlington, Massachusetts, United States
• Bay State Clinical Trials, Inc — Watertown, Massachusetts, United States
• Female Pelvic Medicine & Urogynecology — Grand Rapids, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• CRC of Jackson and Southeast Urogynecology — Jackson, Mississippi, United States
• Sheldon Freedman, MD Ltd — Las Vegas, Nevada, United States
• Arthur Smith Institute for Urology — New Hyde Park, New York, United States
• University of Rochester, Department of Urology — Rochester, New York, United States
• Alliance Urology Specialists — Greensboro, North Carolina, United States
• Wake Forest University Health Sciences Medical Center — Winston-Salem, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Penn. Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina Urology Ambulatory Care — Charleston, South Carolina, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.