Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome

Phase 2

Terminated

Conditions: Bladder Pain Syndrome
Interstitial Cystitis

Interventions: Drug: Lidocaine
Drug: URG101
Drug: Placebo
Drug: Heparin

Registration Number: NCT02591199

Lead Sponsor: Urigen

Brief Summary: 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 Description: This is a Phase 2a, randomized, double-blind, placebo controlled, multicenter, single-dose, pharmacokinetic study designed to determine the efficacy and safety of the combination product (URG101) compared with its individual components (Heparin Sodium and Lidocaine Hydrochloride).

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 (phosphate buffer)

3. Lidocaine hydrocholoride buffered alone

4. Heparin sodium buffered alone

Efficacy and safety assessments will be completed for 24 hours after study drug administration. End of Study Follow-up will be completed by telephone 48 to 72 hours after study drug administration.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 92

Inclusion Criteria

Subjects diagnosed with interstitial cystitis/bladder pain syndrome must meet all of the following criteria to participate in the study:

Have provided written informed consent to participate in this trial
Be male or female, ≥ 18 years of age
Have moderate-to-severe symptoms of bladder pain of bladder origin for at least 9 months prior to the study
May or may not have received a cystoscopy in association with their diagnosis of interstitial cystitis/bladder pain syndrome prior to or at time of screening
Have a score of ≥ 15 and < 30 on the PUF questionnaire, completed at screening
A minimum score of 5 is required on the VAS
Have been using a stable dose of hormone therapy for ≥ 3 months, if female and currently taking hormone therapy

Exclusion Criteria

Pregnant or breastfeeding. For females of child bearing potential and males, if sexually active, must be willing to commit to an acceptable method of birth control for the duration of the study.
Have a known hypersensitivity to heparin or lidocaine
Have used any local anesthetic by any route within 24 hours prior to study drug administration, or used a lidocaine patch within 14 days prior to study drug administration
Have used a tricyclic antidepressant or a gamma-Aminobutyric acid (GABA) analogue (gabapentin or pregabalin) unless taking the medication for ≥ 3 weeks. The stable dose of gabapentin may not exceed 1,200 mg per day, and the stable dose of pregabalin may not exceed 150 mg per day.
Have used any pain medication within 6 hours prior to study drug administration
Have used narcotics or medical marijuana ≤ 3 weeks prior to study entry (generic names: fentanyl, hydrocodone, hydromorphone, levorphanol, medical marijuana, methadone, morphine, oxycodone, propoxyphene, tramadol). Subjects who have received codeine within this time period may be admitted if the use is not chronic, and not within 6 hours of enrollment, such that they are not at risk for GI or opiate withdrawal symptoms that in the opinion of the investigator would impact the subject's study participation due to their ability to follow the study protocol or bias study results.
Have used prohibited drugs as determined by self-report, positive urine drug screen, or in the opinion of the investigator be under the influence of drugs affecting mentation precluding their ability to follow the study protocol or bias study results
Have a known clinically significant abnormal laboratory test value defined by the investigator
Have a neurogenic bladder or other disorder that, in the opinion of the investigator, may cause neurogenic bladder (including Parkinson's disease, multiple sclerosis, epilepsy, myasthenia gravis, movement disorders, spinal cord damage)
Have pain or a pain disorder that, in the opinion of the investigator, would make it difficult to discriminate pelvic pain of bladder origin from the other pain
Have severe depression, bipolar disorder, schizophrenia, anxiety, attention deficit disorder, obsessive compulsive disorder, or other major central nervous system disorder
Have history of arrhythmias, conduction disturbances, or cardiac disease, or any coexisting medical condition that, in the opinion of the investigator, may be significant or interfere with study procedures or interpretation of study results
Had bladder instillation therapy within 7 days prior to study entry or had a prior bladder instillation with heparin and lidocaine and did not respond
Had dilatation (hydrodistention) of bladder within 3 months of study entry
Evidence or suspected presence of cancer detected during cystoscopy prior to or at time of initial screening.
Has received any investigational drug or device within 30 days prior to screening
Is currently enrolled in another investigational drug or device study
Is unwilling or unable to abide by the requirements of the study
Have an actively bleeding lesion or area in the bladder as detected by dipstick urinalysis and investigator assessment, immediately prior to randomization
Have had any of the following: bacterial, chemical (including ketamine and cyclophosphamide) or radiation cystitis; gynecological, urological or rectal cancer; current chemotherapy; tuberculous cystitis; urinary schistosomiasis; bladder or uretal calculi; vaginitis or genital herpes; urethral diverticulum or bladder fistulae.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine	Lidocaine	A single 15 mL dose of buffered Lidocaine (200 mg) delivered to the bladder via catheter.
URG101	URG101	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	Placebo	A single 15 mL dose of placebo delivered to the bladder via catheter.
Heparin	Heparin	A single 15 mL dose of buffered Heparin (50,000 IU) delivered to the bladder.

Primary Outcome Measures

Name	Time	Method
Change in bladder pain differences from baseline as determined by using the Visual Analog Scale (VAS)	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).

Secondary Outcome Measures

Name	Time	Method
Change in urgency from baseline as determined using the VAS	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	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)	Up to 72 hours	Adverse events reported after treatment with URG101 compared to lidocaine alone, heparin alone, and placebo.

Trial Locations

Locations (11): IC Study, LLC
🇺🇸
Escondido, California, United States
Rutgers Women's Health Clinic
🇺🇸
New Brunswick, New Jersey, United States
University of California San Diego
🇺🇸
San Diego, California, United States
Georgia Urology
🇺🇸
Cartersville, Georgia, United States
The Urogynecology Center
🇺🇸
Overland Park, Kansas, United States
Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
The Arthur Smith Institue for Urology- North Shore Long Island Jewish Health System
🇺🇸
Lake Success, New York, United States
Sanford Research
🇺🇸
Sioux Falls, South Dakota, United States
Urology of Virginia, PLLC
🇺🇸
Virginia Beach, Virginia, United States
MetroHealth System, Center for Advanced Gynecology
🇺🇸
Cleveland, Ohio, United States