Bladder Pain Syndrome, Interstitial Cystitis, Painful Bladder Syndrome
Conditions
Keywords
bladder, pain, urgency, frequency
Brief summary
A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.
Interventions
DRUGURG101
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.
DRUGPlacebo
Liquid formulation without active URG101 drug components
Sponsors
Urigen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male and female subjects \>= 18 years of age * moderate to severe symptoms of PBS/IC * minimum pain/urgency/frequency scores * female subjects on hormone therapy must be on stable dose for \>= 3 months
Exclusion criteria
* positive pregnancy test or pregnant or lactating * narcotics or medical marijuana within 3 months * use of any investigational drug or device within 30 days * bacterial cystitis within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Daytime Bladder Pain Intensity | Through 12 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire | Through 12 hours | 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). |
| Change in Total Symptom Score | Through 12 hours | 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'. |
| Change in Daytime Urinary Urgency Score | Through 12 hours | 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'. |
Countries
United States
Participant flow
Pre-assignment details
A total of 28 participants received at least one dose in both Crossover Group 1 and Crossover Group 2. A third arm, All Dosed Subjects, has been listed to the Participant Flow section to allow for overall study Baseline Characteristics to be entered.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Dosed Includes all participants who received at least one dose of URG101 or Placebo
(Placebo: Liquid formulation without active URG101 drug) | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | All Participants Dosed |
|---|---|
| Age, Customized ≥18 years of age | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 28 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex/Gender, Customized Female | 17 Participants |
| Sex/Gender, Customized Male | 1 Participants |
| Sex/Gender, Customized Unknown | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 8 / 28 | 21 / 28 | 28 / 28 |
| serious Total, serious adverse events | 0 / 28 | 1 / 28 | 1 / 28 |
Outcome results
Primary
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
Population: Subjects included in this analysis must have received at least the first two dose administrations and must have been determined to be evaluable per the Statistical Analysis Plan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Change in Daytime Bladder Pain Intensity | 20.73 Percentage of pain scale change |
| URG101 | Change in Daytime Bladder Pain Intensity | 41.86 Percentage of pain scale change |
p-value: 0.036395% CI: [-44.43, 2.16]t-test, 1 sided
Secondary
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
Population: Subjects included in this analysis must have received at least the first two dose administrations and must have been determined to be evaluable per the Statistical Analysis Plan.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Daytime Urinary Urgency Score | 13.30 Percentage of change | Standard Deviation 30.53 |
| URG101 | Change in Daytime Urinary Urgency Score | 34.50 Percentage of change | Standard Deviation 30.21 |
Secondary
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
Population: Subjects included in this analysis must have received at least the first two dose administrations and must have been determined to be evaluable per the Statistical Analysis Plan.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire | 2 Participants |
| URG101 | Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire | 9 Participants |
Secondary
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
Population: Subjects included in this analysis must have received at least the first two dose administrations and must have been determined to be evaluable per the Statistical Analysis Plan.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Total Symptom Score | 17.04 Percentage of change | Standard Deviation 29.87 |
| URG101 | Change in Total Symptom Score | 38.31 Percentage of change | Standard Deviation 27.73 |
Post Hoc
Determination of Serum Lidocaine Levels Post Study Drug Administration
Single-timepoint serum lidocaine measure at one hour following intravesical study drug administration
Time frame: 1 hour post-dose
Population: Subjects who received at least one dose of URG101 and met protocol and statistical analysis plan criteria to be deemed evaluable.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Determination of Serum Lidocaine Levels Post Study Drug Administration | 0.51 µg/mL |