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.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's enrollment of 28 is below the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →Urigen is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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