A Phase 2 interventional study of URG101 and Placebo in Painful Bladder Syndrome, Interstitial Cystitis and Bladder Pain Syndrome, sponsored by Urigen. Terminated at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by Urigen · Phase 2, Interventional, and Treatment
A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.
Exclusion Criteria:
Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2
Drug: URG101 · Drug: Placebo
URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2
Drug: URG101 · Drug: Placebo
Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week.
Liquid formulation without active URG101 drug components
Change in Daytime Bladder Pain Intensity
A calculation of average bladder pain intensity differences from baseline to 12 hours post-dose , as determined using an 11-point numerical rating scale (NRS) for bladder pain from time of dosing through 12 hours post dose. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain.
Time frame: Through 12 hours
Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire
Percentage of subjects achieving ≥ 50% improvement in Question 3 of the PORIS questionnaire at 12 hours post-dose. The PORIS questionnaire is an assessment of the subject's condition after treatment compared to before treatment. In particular, Question 3 of the PORIS questionnaire asks subjects to select the category that best describes the overall change in their condition compared to before receiving study medication; the choices are: worse, no better (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), greatly improved (75% improvement), or symptoms gone (100% improvement).
Time frame: Through 12 hours
Change in Total Symptom Score
A calculation of the average percentage change of Total Symptom Score (including Pelvic/Bladder Pain and Urinary Urgency scales) differences from baseline to 12 hours post-dose, as determined using 11-point numerical rating scales (NRS) for Pelvic/Bladder Pain and Urinary Urgency from time of dosing through 12 hours post dose. The 11-point NRS for Pelvic/Bladder Pain is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'. The 11-point NRS for Urinary Urgency (pressure to urinate) is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'.
Time frame: Through 12 hours
Change in Daytime Urinary Urgency Score
A calculation of average percentage change of Urinary Urgency differences from baseline to 12 hours post-dose, as determined using 11-point numerical rating scales (NRS) for Urinary Urgency from time of dosing through 12 hours post dose. The 11-point NRS for Urinary Urgency (pressure to urinate) is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'.
Time frame: Through 12 hours
| Milestone | Crossover Group 1 | Crossover Group 2 |
|---|---|---|
| Started | 18 | 10 |
| Completed | 16 | 10 |
| Not completed | 2 | 0 |
A calculation of average bladder pain intensity differences from baseline to 12 hours post-dose , as determined using an 11-point numerical rating scale (NRS) for bladder pain from time of dosing through 12 hours post dose. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain.
| Percentage of pain scale change | Placebo | URG101 |
|---|---|---|
| Change in Daytime Bladder Pain Intensity | 20.73 (5.04 to 36.41) | 41.86 (27.64 to 56.08) |
Percentage of subjects achieving ≥ 50% improvement in Question 3 of the PORIS questionnaire at 12 hours post-dose. The PORIS questionnaire is an assessment of the subject's condition after treatment compared to before treatment. In particular, Question 3 of the PORIS questionnaire asks subjects to select the category that best describes the overall change in their condition compared to before receiving study medication; the choices are: worse, no better (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), greatly improved (75% improvement), or symptoms gone (100% improvement).
| Participants | Placebo | URG101 |
|---|---|---|
| Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire | 2 | 9 |
A calculation of the average percentage change of Total Symptom Score (including Pelvic/Bladder Pain and Urinary Urgency scales) differences from baseline to 12 hours post-dose, as determined using 11-point numerical rating scales (NRS) for Pelvic/Bladder Pain and Urinary Urgency from time of dosing through 12 hours post dose. The 11-point NRS for Pelvic/Bladder Pain is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'. The 11-point NRS for Urinary Urgency (pressure to urinate) is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'.
| Percentage of change | Placebo | URG101 |
|---|---|---|
| Change in Total Symptom Score | 17.04 ± 29.87 | 38.31 ± 27.73 |
A calculation of average percentage change of Urinary Urgency differences from baseline to 12 hours post-dose, as determined using 11-point numerical rating scales (NRS) for Urinary Urgency from time of dosing through 12 hours post dose. The 11-point NRS for Urinary Urgency (pressure to urinate) is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'.
| Percentage of change | Placebo | URG101 |
|---|---|---|
| Change in Daytime Urinary Urgency Score | 13.30 ± 30.53 | 34.50 ± 30.21 |
Single-timepoint serum lidocaine measure at one hour following intravesical study drug administration
| µg/mL | Evaluable URG101 Subjects |
|---|---|
| Determination of Serum Lidocaine Levels Post Study Drug Administration | 0.51 (0.24 to 2.0) |
Collected over Adverse Event (AE) collection timeframe: for the duration of study conduct (up to 3 study visits or 5 days total) through 24 hours post-last dose of placebo or study drug Serious Adverse Event (SAE) and All-Cause Mortality (ACM) collection timeframe: for the duration of study conduct (up to 3 study visits or 5 days total) through 30 days post-last dose of placebo or study drug. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/28 (0%) | 0/28 (0%) | 8/28 (28.6%) |
| URG101 | 0/28 (0%) | 1/28 (3.6%) | 21/28 (75%) |
| Total | 0/28 (0%) | 1/28 (3.6%) | 28/28 (100%) |
| Event | Placebo | URG101 | Total |
|---|---|---|---|
| Vaginal BleedingReproductive system and breast disorders | 0/28 | 1/28 | 1/28 |
| Event | Placebo | URG101 | Total |
|---|---|---|---|
| HeadacheNervous system disorders | 3/28 | 5/28 | 8/28 |
| Bladder Discomfort/Pain/BurningRenal and urinary disorders | 1/28 | 6/28 | 7/28 |
| Vaginal PainReproductive system and breast disorders | 0/28 | 4/28 | 4/28 |
| DizzinessNervous system disorders | 1/28 | 2/28 | 3/28 |
| Urethral Pain/Burn/DiscomfortRenal and urinary disorders | 1/28 | 1/28 | 2/28 |
| Urinary UrgencyRenal and urinary disorders | 1/28 | 1/28 | 2/28 |
| HematuriaRenal and urinary disorders | 1/28 | 1/28 | 2/28 |
| Urinary Tract InfectionInfections and infestations | 0/28 | 2/28 | 2/28 |
Subjects randomized per crossover arm as of the time of study termination.
| Age, Customized(Participants) | All Participants Dosed |
|---|---|
| ≥18 years of age | 28 |
| Sex/Gender, Customized(Participants) | All Participants Dosed |
|---|---|
| Male | 1 |
| Female | 17 |
| Unknown | 10 |
| Race (NIH/OMB)(Participants) | All Participants Dosed |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 28 |
Plan to share: No
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