Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
Bladder Pain Syndrome
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase 2a, Biphasic Adaptive Design Randomized, Double-Blind, Placebo-Controlled Multi-Center Single Dose Study to Evaluate the Safety and Effectiveness of URG101 Compared With the Individual Components Lidocaine and Heparin in Subjects With Interstitial Cystitis/Bladder Pain Syndrome|
- Change in bladder pain differences from baseline as determined by using the Visual Analog Scale (VAS) [ Time Frame: 24 hours ]The primary objective is to evaluate the change in bladder pain intensity differences from baseline to either 12 hours or 24 hours after administration of URG101 compared with the administration of lidocaine alone, heparin alone, and placebo as determined by using the Visual Analog Scale (VAS).
- Change in urgency from baseline using the VAS [ Time Frame: 24 hours ]Evaluate the change in urgency intensity differences from baseline to 12 or 24 hours after administration of URG101 compared to lidocaine alone, heparin alone, and placebo using the VAS.
- The relationship of plasma lidocaine concentrations at 1 hour after study drug administration to bladder pain and urgency [ Time Frame: 24 hours ]Evaluate the relationship of plasma lidocaine concentrations at 1 hour after study drug administration to bladder pain and urgency at 1 hour, and from baseline to 12 and 24 hours after treatment with URG101 compared to lidocaine alone, heparin alone, and placebo.
- Safety and tolerability of study medication (Adverse events) [ Time Frame: Up to 72 hours ]Adverse events reported after treatment with URG101 compared to lidocaine alone, heparin alone, and placebo.
|Study Start Date:||September 2015|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
A single 15 mL dose of URG101,a mix of buffered Lidocaine (200 mg) and Heparin (50,000 IU), delivered to the bladder via catheter.
Placebo Comparator: Placebo
A single 15 mL dose of placebo delivered to the bladder via catheter.
A single 15 mL dose of buffered Lidocaine (200 mg) delivered to the bladder via catheter.
A single 15 mL dose of buffered Heparin (50,000 IU) delivered to the bladder.
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:
- URG101 (buffered lidocaine-heparin)
- Lidocaine Hydrocholoride buffered alone
- Heparin Sodium buffered alone
The study is 24 hours in duration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02591199
|Contact: Kathy Grako, PhD||858-452-7271 ext firstname.lastname@example.org|
|Contact: Amelie Rodrigue-Way, PhD||514-856-2286 ext email@example.com|
|United States, California|
|IC Study, LLC||Recruiting|
|Escondido, California, United States, 92025|
|University of California San Diego||Recruiting|
|San Diego, California, United States, 92103|
|San Diego, California, United States, 92130|
|United States, Georgia|
|Cartersville, Georgia, United States, 30120|
|United States, Kansas|
|The Urogynecology Center||Recruiting|
|Overland Park, Kansas, United States, 66209|
|United States, New York|
|The Arthur Smith Institue for Urology- North Shore Long Island Jewish Health System||Recruiting|
|Lake Success, New York, United States, 11042|
|United States, North Carolina|
|Wake Forest University Health Sciences||Recruiting|
|Winston-Salem, North Carolina, United States, 27103|
|United States, Ohio|
|MetroHealth System, Center for Advanced Gynecology||Recruiting|
|Cleveland, Ohio, United States, 44109|
|United States, South Carolina|
|Medical University of South Carolina||Not yet recruiting|
|Charleston, South Carolina, United States, 29425|
|United States, South Dakota|
|Sioux Falls, South Dakota, United States, 57105|
|United States, Virginia|
|Urology of Virginia, PLLC||Recruiting|
|Virginia Beach, Virginia, United States, 23462|
|Study Chair:||C. Lowell Parsons, MD||Urigen|