Last updated on June 2016

Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome


Brief description of study

The purpose of this study is to determine if the combination product (URG101) is safe and effective versus its individual components (Heparin Sodium and Lidocaine Hydrochloride) for the treatment of Interstitial Cystitis/Bladder Pain Syndrome. The study is randomized and double-blinded such that neither the subject nor doctor will know which drug or placebo is received.

Detailed Study Description

This is a biphasic adaptive design phase 2a, prospective, randomized, double-blind, placebo controlled, multicenter, single-dose, pharmacokinetic study designed to determine the efficacy and safety of the combination product (URG101) with its individual components (Heparin Sodium and Lidocaine Hydrochloride). The study will consist of a run-in phase of 48 subjects and an investigational phase of up to 300 subjects. Eligible subjects exhibiting moderate to severe symptoms of bladder pain associated with their diagnosis of interstitial cystitis/bladder pain syndrome who have signed informed consent, will be screened and provisionally enrolled for intravesical treatment. On the day of study drug administration subjects will be randomized (2:1:2:1; URG101:placebo:lidocaine:heparin) and will receive a single administration of one of four intravesical treatments in a blinded fashion, based on random assignment: 1. URG101 (buffered lidocaine-heparin) 2. Placebo 3. Lidocaine Hydrocholoride buffered alone 4. Heparin Sodium buffered alone The study is 24 hours in duration.

Clinical Study Identifier: NCT02591199

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Kathy Grako, PhD

IC Study, LLC
Escondido, CA United States
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Kathy Grako, PhD

University of California San Diego
San Diego, CA United States
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Kathy Grako, PhD

Scripps Clinic
San Diego, CA United States
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Kathy Grako, PhD

Georgia Urology
Cartersville, GA United States
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Kathy Grako, PhD

The Urogynecology Center
Overland Park, KS United States
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Kathy Grako, PhD

The Arthur Smith Institue for Urology- North Shore Long Island Jewish Health System
Lake Success, NY United States
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Kathy Grako, PhD

Wake Forest University Health Sciences
Winston-Salem, NC United States
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Kathy Grako, PhD

MetroHealth System, Center for Advanced Gynecology
Cleveland, OH United States
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Kathy Grako, PhD

Medical University of South Carolina
Charleston, SC United States
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Kathy Grako, PhD

Sanford Research
Sioux Falls, SD United States
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Kathy Grako, PhD

Urology of Virginia, PLLC
Virginia Beach, VA United States
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