Trial · NCT02591199
Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
NCT02591199, Phase 2, Terminated, Urigen; results first posted 2026-02-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome. Trials, record NCT02591199. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02591199
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
- NCT number
- NCT02591199
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 91 participants, actual
- Lead sponsor
- Urigen
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Interventions
- URG101, Placebo, Lidocaine, Heparin
- First posted
- 2015-10-29
- Last updated
- 2026-02-03
- Results first posted
- 2026-02-03
- 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.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 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. |
| Primary | 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 | 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 SPID-12 values for URG101. The full range of results of the average SPID-12 difference could be -119 to +59. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 12 hours | Subjects included in this analysis must have received a dose of the applicable study treatment and completed through the 12 hour SPID collection timepoint. Intent to Treat / Safety Population includes all subjects who received the relevant dose; Per Protocol Population includes all subjects who met entrance criteria; Per Protocol Instillation History includes a subset of the Per Protocol Population who previously received at least one instillation treatment. | units on a scale*hours | MEAN |
| PRIMARY | 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 | 12 hours | Overall numbers of participants reflects all participants who received at least one dose of study drug (URG101), comparators (Heparin or Lidocaine), or placebo. The above arm numbers compare URG101 to its individual components of heparin, lidocaine, and placebo, respectively. | units on a scale*hours | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | URG101 | Intent to Treat / Safety Population | -30.81 | Standard Deviation 21.641 | units on a scale*hours |
| 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 | Heparin | Intent to Treat / Safety Population | -22.50 | Standard Deviation 25.918 | units on a scale*hours |
| 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 | Lidocaine | Intent to Treat / Safety Population | -27.50 | Standard Deviation 26.121 | units on a scale*hours |
| 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 | Placebo | Intent to Treat / Safety Population | -19.63 | Standard Deviation 18.558 | units on a scale*hours |
| 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 | URG101 | Per Protocol Population | -33.41 | Standard Deviation 20.89 | units on a scale*hours |
| 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 | Heparin | Per Protocol Population | -24.11 | Standard Deviation 26.11 | units on a scale*hours |
| 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 | Lidocaine | Per Protocol Population | -26.43 | Standard Deviation 26.76 | units on a scale*hours |
| 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 | Placebo | Per Protocol Population | -15.42 | Standard Deviation 17.74 | units on a scale*hours |
| 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 | URG101 | Per Protocol-Instillation (history of receiving bladder instillations) Population | -37.51 | Standard Deviation 18.06 | units on a scale*hours |
| 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 | Heparin | Per Protocol-Instillation (history of receiving bladder instillations) Population | -12.38 | Standard Deviation 22.38 | units on a scale*hours |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | URG101 | 31 | |
| Overall Study | STARTED | Heparin | 15 | |
| Overall Study | STARTED | Lidocaine | 29 | |
| Overall Study | STARTED | Placebo | 16 | |
| Overall Study | COMPLETED | URG101 | 31 | |
| Overall Study | COMPLETED | Heparin | 15 | |
| Overall Study | COMPLETED | Lidocaine | 29 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | NOT COMPLETED | URG101 | 0 | |
| Overall Study | NOT COMPLETED | Heparin | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | URG101 | 2 | 31 | |
| other | Nausea | Gastrointestinal disorders | Heparin | 0 | 15 | |
| other | Nausea | Gastrointestinal disorders | Lidocaine | 2 | 29 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 16 | |
| other | Vomiting | Gastrointestinal disorders | URG101 | 0 | 31 | |
| other | Vomiting | Gastrointestinal disorders | Heparin | 0 | 15 | |
| other | Vomiting | Gastrointestinal disorders | Lidocaine | 0 | 29 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 16 | |
| other | Vertigo | Nervous system disorders | URG101 | 0 | 31 | |
| other | Vertigo | Nervous system disorders | Heparin | 0 | 15 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | URG101 | 0 | 31 |
| Total, all-cause mortality | Heparin | 0 | 15 |
| Total, all-cause mortality | Lidocaine | 0 | 29 |
| Total, all-cause mortality | Placebo | 0 | 16 |
| Total, other adverse events | URG101 | 3 | 31 |
| Total, other adverse events | Heparin | 1 | 15 |
| Total, other adverse events | Lidocaine | 5 | 29 |
| Total, other adverse events | Placebo | 3 | 16 |
| Total, serious adverse events | URG101 | 0 | 31 |
| Total, serious adverse events | Heparin | 0 | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02591199
GET https://conductscience.org/api/trials/v1/NCT02591199/results?page=2