Trial Outcomes & Findings for Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis (NCT NCT00517868)
NCT ID: NCT00517868
Last Updated: 2024-08-23
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Through 12 hours
Results posted on
2024-08-23
Participant Flow
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.
Participant milestones
| Measure |
Crossover Group 1
Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2
URG101: 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.
Placebo: Liquid formulation without active URG101 drug components
|
Crossover Group 2
URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2
URG101: 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.
Placebo: Liquid formulation without active URG101 drug components
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
10
|
|
Overall Study
COMPLETED
|
16
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis
Baseline characteristics by cohort
| Measure |
All Participants Dosed
n=28 Participants
Includes all participants who received at least one dose of URG101 or Placebo
(Placebo: Liquid formulation without active URG101 drug)
|
|---|---|
|
Age, Customized
≥18 years of age
|
28 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
17 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through 12 hoursPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=18 Participants
Inclusive of all subjects who received at least one placebo dose as either the first or second dose administration.
|
URG101
n=18 Participants
Inclusive of all subjects who received at least one URG101 (study drug) dose as either the first or second dose administration.
|
|---|---|---|
|
Change in Daytime Bladder Pain Intensity
|
20.73 Percentage of pain scale change
Interval 5.04 to 36.41
|
41.86 Percentage of pain scale change
Interval 27.64 to 56.08
|
SECONDARY outcome
Timeframe: Through 12 hoursPopulation: 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.
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).
Outcome measures
| Measure |
Placebo
n=18 Participants
Inclusive of all subjects who received at least one placebo dose as either the first or second dose administration.
|
URG101
n=18 Participants
Inclusive of all subjects who received at least one URG101 (study drug) dose as either the first or second dose administration.
|
|---|---|---|
|
Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire
|
2 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Through 12 hoursPopulation: 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.
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'.
Outcome measures
| Measure |
Placebo
n=18 Participants
Inclusive of all subjects who received at least one placebo dose as either the first or second dose administration.
|
URG101
n=18 Participants
Inclusive of all subjects who received at least one URG101 (study drug) dose as either the first or second dose administration.
|
|---|---|---|
|
Change in Total Symptom Score
|
17.04 Percentage of change
Standard Deviation 29.87
|
38.31 Percentage of change
Standard Deviation 27.73
|
SECONDARY outcome
Timeframe: Through 12 hoursPopulation: 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.
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'.
Outcome measures
| Measure |
Placebo
n=18 Participants
Inclusive of all subjects who received at least one placebo dose as either the first or second dose administration.
|
URG101
n=18 Participants
Inclusive of all subjects who received at least one URG101 (study drug) dose as either the first or second dose administration.
|
|---|---|---|
|
Change in Daytime Urinary Urgency Score
|
13.30 Percentage of change
Standard Deviation 30.53
|
34.50 Percentage of change
Standard Deviation 30.21
|
POST_HOC outcome
Timeframe: 1 hour post-dosePopulation: Subjects who received at least one dose of URG101 and met protocol and statistical analysis plan criteria to be deemed evaluable.
Single-timepoint serum lidocaine measure at one hour following intravesical study drug administration
Outcome measures
| Measure |
Placebo
n=18 Participants
Inclusive of all subjects who received at least one placebo dose as either the first or second dose administration.
|
URG101
Inclusive of all subjects who received at least one URG101 (study drug) dose as either the first or second dose administration.
|
|---|---|---|
|
Determination of Serum Lidocaine Levels Post Study Drug Administration
|
0.51 µg/mL
Interval 0.24 to 2.0
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
URG101
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Total
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=28 participants at risk
Inclusive of all AEs following placebo dose exposures.
|
URG101
n=28 participants at risk
Inclusive of all AEs following URG101 (study drug) dose exposures.
|
Total
n=28 participants at risk
Inclusive of all AEs following all placebo and URG101 dose exposures.
|
|---|---|---|---|
|
Reproductive system and breast disorders
Vaginal Bleeding
|
0.00%
0/28 • 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
|
3.6%
1/28 • 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
|
3.6%
1/28 • 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
|
Other adverse events
| Measure |
Placebo
n=28 participants at risk
Inclusive of all AEs following placebo dose exposures.
|
URG101
n=28 participants at risk
Inclusive of all AEs following URG101 (study drug) dose exposures.
|
Total
n=28 participants at risk
Inclusive of all AEs following all placebo and URG101 dose exposures.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
10.7%
3/28 • 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
|
17.9%
5/28 • 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
|
28.6%
8/28 • 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
|
|
Nervous system disorders
Dizziness
|
3.6%
1/28 • 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
|
7.1%
2/28 • 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
|
10.7%
3/28 • 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
|
|
Renal and urinary disorders
Bladder Discomfort/Pain/Burning
|
3.6%
1/28 • 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
|
21.4%
6/28 • 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
|
25.0%
7/28 • 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
|
|
Renal and urinary disorders
Urethral Pain/Burn/Discomfort
|
3.6%
1/28 • 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
|
3.6%
1/28 • 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
|
7.1%
2/28 • 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
|
|
Renal and urinary disorders
Urinary Urgency
|
3.6%
1/28 • 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
|
3.6%
1/28 • 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
|
7.1%
2/28 • 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
|
|
Renal and urinary disorders
Hematuria
|
3.6%
1/28 • 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
|
3.6%
1/28 • 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
|
7.1%
2/28 • 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
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/28 • 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
|
7.1%
2/28 • 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
|
7.1%
2/28 • 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
|
|
Reproductive system and breast disorders
Vaginal Pain
|
0.00%
0/28 • 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
|
14.3%
4/28 • 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
|
14.3%
4/28 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place