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

NCT02591199 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2026-02-03

Study results available
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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

  • Interstitial Cystitis
  • Bladder Pain Syndrome

Interventions

DRUG

URG101

DRUG

Placebo

DRUG

Lidocaine

DRUG

Heparin

Sponsors & Collaborators

  • Urigen

    lead INDUSTRY

Principal Investigators

  • C. Lowell Parsons, MD · Urigen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-05-14
Completion
2018-06-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02591199 on ClinicalTrials.gov