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

NCT02591199 | Terminated Phase 2 Results DMC

• 1 other identifier: URG101-105
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 11

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.

Conditions

Bladder Pain Syndrome; Interstitial Cystitis

Outcome Measures

Primary Outcomes (2)

• Average of Bladder Sum of Pain Intensity Differences From Baseline to 12 Hours (SPID-12) as Determined Using an 11-point Numeric Rating Scale (NRS) for Pain Intensity

  A calculation of average bladder Sum of Pain Intensity Differences from Baseline to 12 hours (SPID-12). A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. The average SPID-12 is calculated by multiplying the Pain Intensity Difference score at each time point by the duration since the preceding time point and then summing these values over the specific time period. A lower, negative average SPID-12 difference is better and indicates a reduction in pain intensity compared to the baseline score, whereas a positive score indicates an increase in pain intensity compared to baseline. The full range of results of the average SPID-12 difference could be -119 to +59.

  12 hours

• Change of Bladder Sum of Pain Intensity Differences From Baseline to 12 Hours (SPID-12) as Determined Using an 11-point Numeric Rating Scale (NRS) for Pain Intensity

  A calculation of bladder Sum of Pain Intensity Differences from Baseline to 12 hours (SPID-12) after administration of URG101 compared with the SPID-12 after administration of lidocaine alone, heparin alone, and placebo. A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. A negative value indicates lower SPID-12 values for URG101. The full range of results of the average SPID-12 difference could be -119 to +59.

  12 hours

Study Arms (4)

URG101

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Drug: Placebo

Lidocaine

EXPERIMENTAL

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

Drug: Lidocaine

Heparin

EXPERIMENTAL

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

Drug: Heparin

Interventions

Lidocaine DRUG

Lidocaine

Heparin DRUG

Heparin

URG101 DRUG

URG101

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Urigen: lead

Study Sites (11)

IC Study, LLC

Escondido, California, 92025, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

Georgia Urology

Cartersville, Georgia, 30120, United States

Location

The Urogynecology Center

Overland Park, Kansas, 66209, United States

Location

Rutgers Women's Health Clinic

New Brunswick, New Jersey, 08901, United States

Location

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

Lake Success, New York, 11042, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27103, United States

Location

MetroHealth System, Center for Advanced Gynecology

Cleveland, Ohio, 44109, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Sanford Research

Sioux Falls, South Dakota, 57105, United States

Location

Urology of Virginia, PLLC

Virginia Beach, Virginia, 23462, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Lidocaine; Heparin

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Glycosaminoglycans; Polysaccharides; Carbohydrates

Limitations and Caveats

The IDMC reported a trend toward significance for URG101; but it was determined that \>300 subjects would be required to reach significance. The data showed inconsistencies between different sites that could affect the ability to pool the data and could not be explained in a blinded analysis. Therefore, at 92 subjects enrolled, the study was terminated early due to data inconsistent with the experimental plan, lack of funding. There is no SAP. Results are limited to primary endpoint and safety.

Results Point of Contact

• Title: CEO
• Organization: Vaneltix Pharma, Inc.

info@vaneltix.com

732-354-3217

Study Officials

• C. Lowell Parsons, MD

  Urigen

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: October 29, 2015
• Study Start: September 1, 2015
• Primary Completion: May 14, 2018
• Study Completion: June 18, 2018
• Last Updated: February 3, 2026
• Results First Posted: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)