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NCT02591199 · ClinicalTrials.gov registry record · Phase 2
Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
A Phase 2 study, sponsored by Urigen.
- Terminated
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
NCT02591199: Clinical Trial Phase 2 study, sponsored by Urigen.
NCT02591199 is a Phase 2 study that was terminated before completion, run by Urigen. The registered enrollment target is 91 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02591199, a Phase 2 study, was terminated before completion, sponsored by Urigen.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
Study 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.
Primary Outcome
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 differ
Interventions
- DRUG Placebo
- DRUG Lidocaine
- DRUG Heparin
- DRUG URG101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2015-09 |
| Est. Completion | 2018-06-18 |
| Phase | Phase 2 |
Why NCT02591199 stopped before completion
NCT02591199 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02591199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02591199 about?
NCT02591199 is a clinical study titled "Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome". 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 nei...
What is the current status of trial NCT02591199?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2015-09. Estimated completion is 2018-06-18.
What interventions are being tested in trial NCT02591199?
The interventions under investigation include: Placebo (DRUG), Lidocaine (DRUG), Heparin (DRUG), URG101 (DRUG).
Who is sponsoring clinical trial NCT02591199?
This trial is sponsored by Urigen, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02591199's enrollment target sits among peer trials
91 771st of 2000 higher than 1,229 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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