Trial Outcomes & Findings for Paxerol™ for Treatment of Nocturia - A Phase II Placebo-Controlled Trial (NCT NCT02646826)
NCT ID: NCT02646826
Last Updated: 2019-06-14
Results Overview
Change in number of nocturia episodes associated with one of three dose levels of Paxerol vs. placebo is assessed during the 2-week treatment period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
Up to 2 weeks
Results posted on
2019-06-14
Participant Flow
Participant milestones
| Measure |
Placebo
Subjects are treated with placebo tablets.
Placebo: Subjects are treated with Placebo tablets
|
Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen
Subjects are treated with the first dose level of Paxerol.
Paxerol - Dose Level 1: Subjects are treated with the first dose level of Paxerol
|
Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen
Subjects are treated with the second dose level of Paxerol.
Paxerol - Dose Level 2: Subjects are treated with the second dose level of Paxerol
|
Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen
Subjects are treated with the third dose level of Paxerol.
Paxerol - Dose Level 3: Subjects are treated with the third dose level of Paxerol
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
21
|
22
|
|
Overall Study
COMPLETED
|
19
|
22
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=21 Participants
Subjects are treated with placebo tablets.
Placebo: Subjects are treated with Placebo tablets
|
Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen
n=22 Participants
Subjects are treated with the first dose level of Paxerol.
Paxerol - Dose Level 1: Subjects are treated with the first dose level of Paxerol
|
Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen
n=21 Participants
Subjects are treated with the second dose level of Paxerol.
Paxerol - Dose Level 2: Subjects are treated with the second dose level of Paxerol
|
Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen
n=22 Participants
Subjects are treated with the third dose level of Paxerol.
Paxerol - Dose Level 3: Subjects are treated with the third dose level of Paxerol
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.8 years
n=21 Participants
|
60.4 years
n=22 Participants
|
59.9 years
n=21 Participants
|
59.9 years
n=22 Participants
|
59.7 years
n=86 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=21 Participants
|
4 Participants
n=22 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=22 Participants
|
18 Participants
n=86 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=21 Participants
|
18 Participants
n=22 Participants
|
16 Participants
n=21 Participants
|
15 Participants
n=22 Participants
|
68 Participants
n=86 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
21 participants
n=21 Participants
|
22 participants
n=22 Participants
|
21 participants
n=21 Participants
|
22 participants
n=22 Participants
|
86 participants
n=86 Participants
|
|
Average nightly voids
|
3.6 voids per night
STANDARD_DEVIATION 0.7 • n=21 Participants
|
3.3 voids per night
STANDARD_DEVIATION 1.0 • n=22 Participants
|
3.9 voids per night
STANDARD_DEVIATION 1.4 • n=21 Participants
|
3.6 voids per night
STANDARD_DEVIATION 1.0 • n=22 Participants
|
3.6 voids per night
STANDARD_DEVIATION 1.0 • n=86 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeksChange in number of nocturia episodes associated with one of three dose levels of Paxerol vs. placebo is assessed during the 2-week treatment period.
Outcome measures
| Measure |
Placebo
n=21 Participants
Subjects are treated with placebo tablets.
Placebo: Subjects are treated with Placebo tablets
|
Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen
n=22 Participants
Subjects are treated with the first dose level of Paxerol.
Paxerol - Dose Level 1: Subjects are treated with the first dose level of Paxerol
|
Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen
n=21 Participants
Subjects are treated with the second dose level of Paxerol.
Paxerol - Dose Level 2: Subjects are treated with the second dose level of Paxerol
|
Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen
n=22 Participants
Subjects are treated with the third dose level of Paxerol.
Paxerol - Dose Level 3: Subjects are treated with the third dose level of Paxerol
|
|---|---|---|---|---|
|
Change in Nocturia Episodes
Baseline
|
3.6 average nightly voids
Standard Deviation 0.7
|
3.3 average nightly voids
Standard Deviation 1.0
|
3.9 average nightly voids
Standard Deviation 1.4
|
3.6 average nightly voids
Standard Deviation 1.0
|
|
Change in Nocturia Episodes
Two Weeks Using Pills
|
3.2 average nightly voids
Standard Deviation 1.0
|
2.2 average nightly voids
Standard Deviation 1.0
|
2.5 average nightly voids
Standard Deviation 1.0
|
2.4 average nightly voids
Standard Deviation 1.0
|
|
Change in Nocturia Episodes
Change of Nocturia Episodes
|
-0.3 average nightly voids
Standard Deviation 0.7
|
-1.1 average nightly voids
Standard Deviation 0.7
|
-1.4 average nightly voids
Standard Deviation 1.4
|
-1.3 average nightly voids
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: Up to 2 weeksThe degree of clinical benefit, via NQOL, associated with one of three dose levels of Paxerol vs. placebo is assessed after the 2-week treatment period. This is on a scale of 0 to 100, with 0 being the best score.
Outcome measures
| Measure |
Placebo
n=21 Participants
Subjects are treated with placebo tablets.
Placebo: Subjects are treated with Placebo tablets
|
Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen
n=22 Participants
Subjects are treated with the first dose level of Paxerol.
Paxerol - Dose Level 1: Subjects are treated with the first dose level of Paxerol
|
Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen
n=21 Participants
Subjects are treated with the second dose level of Paxerol.
Paxerol - Dose Level 2: Subjects are treated with the second dose level of Paxerol
|
Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen
n=22 Participants
Subjects are treated with the third dose level of Paxerol.
Paxerol - Dose Level 3: Subjects are treated with the third dose level of Paxerol
|
|---|---|---|---|---|
|
Clinical Benefit Based on Nocturia Quality of Life (NQOL).
Two Weeks Using Pills
|
42.1 score on a scale
Standard Deviation 18.3
|
40.7 score on a scale
Standard Deviation 21.4
|
40.5 score on a scale
Standard Deviation 18.1
|
37.4 score on a scale
Standard Deviation 23.4
|
|
Clinical Benefit Based on Nocturia Quality of Life (NQOL).
Baseline Quality of Life
|
52.5 score on a scale
Standard Deviation 15.2
|
52.3 score on a scale
Standard Deviation 20.4
|
63.6 score on a scale
Standard Deviation 19.6
|
59.7 score on a scale
Standard Deviation 20.7
|
SECONDARY outcome
Timeframe: Up to 2 weeksDFUS will be assessed during the 2-week treatment period with one of three dose levels of Paxerol vs. placebo
Outcome measures
| Measure |
Placebo
n=21 Participants
Subjects are treated with placebo tablets.
Placebo: Subjects are treated with Placebo tablets
|
Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen
n=22 Participants
Subjects are treated with the first dose level of Paxerol.
Paxerol - Dose Level 1: Subjects are treated with the first dose level of Paxerol
|
Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen
n=21 Participants
Subjects are treated with the second dose level of Paxerol.
Paxerol - Dose Level 2: Subjects are treated with the second dose level of Paxerol
|
Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen
n=22 Participants
Subjects are treated with the third dose level of Paxerol.
Paxerol - Dose Level 3: Subjects are treated with the third dose level of Paxerol
|
|---|---|---|---|---|
|
Duration of First Undisturbed Sleep (DFUS)
Baseline DFUS
|
1.8 Hours
Standard Deviation 0.7
|
2.2 Hours
Standard Deviation 0.9
|
2.0 Hours
Standard Deviation 1.1
|
2.1 Hours
Standard Deviation 0.8
|
|
Duration of First Undisturbed Sleep (DFUS)
Two Weeks Using Pills DFUS
|
2.2 Hours
Standard Deviation 0.9
|
2.8 Hours
Standard Deviation 1.3
|
2.7 Hours
Standard Deviation 1.4
|
3.3 Hours
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Up to 2 weeksThe total hours of nightly sleep will be assessed during the 2-week treatment period with one of three dose levels of Paxerol vs. placebo
Outcome measures
| Measure |
Placebo
n=21 Participants
Subjects are treated with placebo tablets.
Placebo: Subjects are treated with Placebo tablets
|
Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen
n=22 Participants
Subjects are treated with the first dose level of Paxerol.
Paxerol - Dose Level 1: Subjects are treated with the first dose level of Paxerol
|
Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen
n=21 Participants
Subjects are treated with the second dose level of Paxerol.
Paxerol - Dose Level 2: Subjects are treated with the second dose level of Paxerol
|
Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen
n=22 Participants
Subjects are treated with the third dose level of Paxerol.
Paxerol - Dose Level 3: Subjects are treated with the third dose level of Paxerol
|
|---|---|---|---|---|
|
Total Hours of Nightly Sleep
Baseline Hours of Sleep
|
8.5 Hours per night
Standard Deviation 1.0
|
7.9 Hours per night
Standard Deviation 1.0
|
8.6 Hours per night
Standard Deviation 1.6
|
8.6 Hours per night
Standard Deviation 1.3
|
|
Total Hours of Nightly Sleep
Two Weeks Using Pills Hours of Sleep
|
8.3 Hours per night
Standard Deviation 1.0
|
7.7 Hours per night
Standard Deviation 1.9
|
8.5 Hours per night
Standard Deviation 1.4
|
8.4 Hours per night
Standard Deviation 1.3
|
|
Total Hours of Nightly Sleep
Change from Baseline
|
-0.3 Hours per night
Standard Deviation 0.6
|
-0.3 Hours per night
Standard Deviation 0.6
|
-0.2 Hours per night
Standard Deviation 1.0
|
-0.2 Hours per night
Standard Deviation 0.6
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=21 participants at risk
Subjects are treated with placebo tablets.
Placebo: Subjects are treated with Placebo tablets
|
Paxerol - Dose Level 1 325 mg Acetaminophen 150 mg Ibuprofen
n=22 participants at risk
Subjects are treated with the first dose level of Paxerol.
Paxerol - Dose Level 1: Subjects are treated with the first dose level of Paxerol
|
Paxerol - Dose Level 2 650 mg Acetaminophen 300 mg Ibuprofen
n=21 participants at risk
Subjects are treated with the second dose level of Paxerol.
Paxerol - Dose Level 2: Subjects are treated with the second dose level of Paxerol
|
Paxerol - Dose Level 3 975 mg Acetaminophen 450 mg Ibuprofen
n=22 participants at risk
Subjects are treated with the third dose level of Paxerol.
Paxerol - Dose Level 3: Subjects are treated with the third dose level of Paxerol
|
|---|---|---|---|---|
|
Renal and urinary disorders
Urinary tract infection
|
4.8%
1/21 • Number of events 1 • Adverse events were tracked during the 4 week study.
|
0.00%
0/22 • Adverse events were tracked during the 4 week study.
|
14.3%
3/21 • Number of events 3 • Adverse events were tracked during the 4 week study.
|
4.5%
1/22 • Number of events 1 • Adverse events were tracked during the 4 week study.
|
|
Gastrointestinal disorders
Nausea, abdominal pain, vomiting
|
4.8%
1/21 • Number of events 1 • Adverse events were tracked during the 4 week study.
|
4.5%
1/22 • Number of events 1 • Adverse events were tracked during the 4 week study.
|
4.8%
1/21 • Number of events 1 • Adverse events were tracked during the 4 week study.
|
0.00%
0/22 • Adverse events were tracked during the 4 week study.
|
|
Renal and urinary disorders
Renal and Urinary
|
0.00%
0/21 • Adverse events were tracked during the 4 week study.
|
4.5%
1/22 • Number of events 1 • Adverse events were tracked during the 4 week study.
|
0.00%
0/21 • Adverse events were tracked during the 4 week study.
|
4.5%
1/22 • Number of events 1 • Adverse events were tracked during the 4 week study.
|
|
Musculoskeletal and connective tissue disorders
Pain in flank
|
4.8%
1/21 • Number of events 1 • Adverse events were tracked during the 4 week study.
|
0.00%
0/22 • Adverse events were tracked during the 4 week study.
|
0.00%
0/21 • Adverse events were tracked during the 4 week study.
|
0.00%
0/22 • Adverse events were tracked during the 4 week study.
|
|
Blood and lymphatic system disorders
Hemoglobin A1c, increase
|
0.00%
0/21 • Adverse events were tracked during the 4 week study.
|
0.00%
0/22 • Adverse events were tracked during the 4 week study.
|
0.00%
0/21 • Adverse events were tracked during the 4 week study.
|
4.5%
1/22 • Number of events 1 • Adverse events were tracked during the 4 week study.
|
|
Musculoskeletal and connective tissue disorders
Pain, chest, non-cardiac
|
4.8%
1/21 • Number of events 1 • Adverse events were tracked during the 4 week study.
|
0.00%
0/22 • Adverse events were tracked during the 4 week study.
|
4.8%
1/21 • Number of events 1 • Adverse events were tracked during the 4 week study.
|
0.00%
0/22 • Adverse events were tracked during the 4 week study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place