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

• ClinicalTrials.gov Identifier: NCT02591199
• Recruitment Status: Terminated
• First Posted: October 29, 2015
• Last Update Posted: August 26, 2020
• Sponsor: Urigen
• Information provided by (Responsible Party): Urigen

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Interstitial Cystitis; Bladder Pain Syndrome	Drug: URG101; Drug: Placebo; Drug: Lidocaine; Drug: Heparin	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2a, 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
• Study Start Date: September 2015
• Actual Primary Completion Date: May 14, 2018
• Actual Study Completion Date: June 18, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: URG101
Placebo Comparator: Placebo; A single 15 mL dose of placebo delivered to the bladder via catheter.	Drug: Placebo
Experimental: Lidocaine; A single 15 mL dose of buffered Lidocaine (200 mg) delivered to the bladder via catheter.	Drug: Lidocaine
Experimental: Heparin; A single 15 mL dose of buffered Heparin (50,000 IU) delivered to the bladder.	Drug: Heparin

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. Change in urgency from baseline as determined 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.
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

1. Have provided written informed consent to participate in this trial
2. Be male or female, ≥ 18 years of age
3. Have moderate-to-severe symptoms of bladder pain of bladder origin for at least 9 months prior to the study
4. 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
5. Have a score of ≥ 15 and < 30 on the PUF questionnaire, completed at screening
6. A minimum score of 5 is required on the VAS
7. Have been using a stable dose of hormone therapy for ≥ 3 months, if female and currently taking hormone therapy

Exclusion Criteria:

1. 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.
2. Have a known hypersensitivity to heparin or lidocaine
3. 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
4. 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.
5. Have used any pain medication within 6 hours prior to study drug administration
6. 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.
7. 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
8. Have a known clinically significant abnormal laboratory test value defined by the investigator
9. 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)
10. 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
11. Have severe depression, bipolar disorder, schizophrenia, anxiety, attention deficit disorder, obsessive compulsive disorder, or other major central nervous system disorder
12. 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
13. 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
14. Had dilatation (hydrodistention) of bladder within 3 months of study entry
15. Evidence or suspected presence of cancer detected during cystoscopy prior to or at time of initial screening.
16. Has received any investigational drug or device within 30 days prior to screening
17. Is currently enrolled in another investigational drug or device study
18. Is unwilling or unable to abide by the requirements of the study
19. Have an actively bleeding lesion or area in the bladder as detected by dipstick urinalysis and investigator assessment, immediately prior to randomization
20. 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.

Contacts and Locations

Locations

United States, California

IC Study, LLC

Escondido, California, United States, 92025

University of California San Diego

San Diego, California, United States, 92103

United States, Georgia

Georgia Urology

Cartersville, Georgia, United States, 30120

United States, Kansas

The Urogynecology Center

Overland Park, Kansas, United States, 66209

United States, New Jersey

Rutgers Women's Health Clinic

New Brunswick, New Jersey, United States, 08901

United States, New York

The Arthur Smith Institue for Urology- North Shore Long Island Jewish Health System

Lake Success, New York, United States, 11042

United States, North Carolina

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27103

United States, Ohio

MetroHealth System, Center for Advanced Gynecology

Cleveland, Ohio, United States, 44109

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

United States, South Dakota

Sanford Research

Sioux Falls, South Dakota, United States, 57105

United States, Virginia

Urology of Virginia, PLLC

Virginia Beach, Virginia, United States, 23462

Sponsors and Collaborators

Urigen

Investigators

• Study Chair: C. Lowell Parsons, MD; Urigen

More Information

Additional Information:

Urigen N.A., Inc. homepage 

• Responsible Party: Urigen
• ClinicalTrials.gov Identifier: NCT02591199
• Other Study ID Numbers: URG101-105
• First Posted: October 29, 2015
• Last Update Posted: August 26, 2020
• Last Verified: August 2020

Additional relevant MeSH terms:

Cystitis; Cystitis, Interstitial; Syndrome; Somatoform Disorders; Disease; Pathologic Processes; Mental Disorders; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lidocaine; Heparin; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents