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

NCT ID: NCT02591199

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-06-18

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.

Conditions

Interstitial Cystitis; Bladder Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

URG101

Intervention Type: DRUG

Placebo

A single 15 mL dose of placebo delivered to the bladder via catheter.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Lidocaine

A single 15 mL dose of buffered Lidocaine (200 mg) delivered to the bladder via catheter.

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

Heparin

A single 15 mL dose of buffered Heparin (50,000 IU) delivered to the bladder.

Group Type: EXPERIMENTAL

Heparin

Intervention Type: DRUG

Interventions

URG101

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Lidocaine

Intervention Type: DRUG

Heparin

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Urigen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

C. Lowell Parsons, MD

Role: STUDY_CHAIR

Urigen

Locations

IC Study, LLC

Escondido, California, 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

Rutgers Women's Health Clinic

New Brunswick, New Jersey, United States

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

Lake Success, New York, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

MetroHealth System, Center for Advanced Gynecology

Cleveland, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Sanford Research

Sioux Falls, South Dakota, United States

Urology of Virginia, PLLC

Virginia Beach, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

URG101-105

Identifier Type: -

Identifier Source: org_study_id