NCT02591199

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

Terminated Phase 2 Results posted Last updated 15 January 2026

What this trial tests

Phase 2 trial testing URG101 in Interstitial Cystitis in 91 participants. Terminated before completion.

Timeline

1 September 2015

Primary endpoint
14 May 2018

18 June 2018

Quick facts

Lead sponsor	Urigen
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	91
Start date	1 September 2015
Primary completion	14 May 2018
Estimated completion	18 June 2018
Sites	11 locations across United States

Drugs / interventions tested

• URG101 — full drug profile →
• Placebo
• Lidocaine — full drug profile →
• Heparin (HEPARIN) — full drug profile →

Conditions studied

• Interstitial Cystitis — all drugs for Interstitial Cystitis →
• Bladder Pain Syndrome — all drugs for Bladder Pain Syndrome →

Sponsor

Urigen — full company profile →

Who can join

18 and older, any sex, with Interstitial Cystitis or Bladder Pain Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
  Time frame: 12 hours
  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 a
• 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
  Time frame: 12 hours
  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 SP

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis.
   Imamura M, Scott NW, Wallace SA, Ogah JA, et al · · 2020 · cited 13× · PMID 32734597 · DOI 10.1002/14651858.cd013325.pub2