Trial Outcomes & Findings for Treatment of Patients With Nocturia (NCT NCT00937859)
NCT ID: NCT00937859
Last Updated: 2020-09-18
Results Overview
Change was calculated as the mean number of nocturic episodes per night during the last week of treatment minus the mean number of nocturic episodes at baseline
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
301 participants
Primary outcome timeframe
7 weeks
Results posted on
2020-09-18
Participant Flow
Participant milestones
| Measure |
SER120
All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
|
Placebo
All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration once daily for the remainder of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
153
|
|
Overall Study
COMPLETED
|
129
|
134
|
|
Overall Study
NOT COMPLETED
|
19
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Patients With Nocturia
Baseline characteristics by cohort
| Measure |
SER120
n=145 Participants
All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
|
Placebo
n=149 Participants
All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration with placebo once daily for the remainder of the study.
|
Total
n=294 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
121 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
145 participants
n=5 Participants
|
149 participants
n=7 Participants
|
294 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 weeksPopulation: Intent-to-treat
Change was calculated as the mean number of nocturic episodes per night during the last week of treatment minus the mean number of nocturic episodes at baseline
Outcome measures
| Measure |
SER120
n=145 Participants
All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
|
Placebo
n=149 Participants
All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration with placebo once daily for the remainder of the study.
|
|---|---|---|
|
Change in Mean Number of Nocturic Episodes/Night
|
-1.3 nocturic episodes per night
Standard Deviation 0.9
|
-1.2 nocturic episodes per night
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: 7 weeksPopulation: Intent-to-treat
Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline
Outcome measures
| Measure |
SER120
n=145 Participants
All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
|
Placebo
n=149 Participants
All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration with placebo once daily for the remainder of the study.
|
|---|---|---|
|
Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night
|
58 Participants
|
58 Participants
|
Adverse Events
SER120
Serious events: 2 serious events
Other events: 105 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 108 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SER120
n=148 participants at risk
All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
|
Placebo
n=153 participants at risk
All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration with placebo once daily for the remainder of the study.
|
|---|---|---|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.68%
1/148 • Number of events 1
|
0.00%
0/153
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
0.68%
1/148 • Number of events 1
|
0.00%
0/153
|
|
Psychiatric disorders
mental status changes
|
0.00%
0/148
|
0.65%
1/153 • Number of events 1
|
Other adverse events
| Measure |
SER120
n=148 participants at risk
All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
|
Placebo
n=153 participants at risk
All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration with placebo once daily for the remainder of the study.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
2/148 • Number of events 2
|
4.6%
7/153 • Number of events 7
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
7/148 • Number of events 7
|
2.6%
4/153 • Number of events 4
|
|
Nervous system disorders
Headache
|
4.1%
6/148 • Number of events 6
|
10.5%
16/153 • Number of events 16
|
|
Nervous system disorders
Dizziness
|
1.4%
2/148 • Number of events 2
|
4.6%
7/153 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
29.7%
44/148 • Number of events 44
|
37.9%
58/153 • Number of events 58
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
12.2%
18/148 • Number of events 18
|
14.4%
22/153 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
8.8%
13/148 • Number of events 13
|
14.4%
22/153 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.4%
5/148 • Number of events 5
|
4.6%
7/153 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.68%
1/148 • Number of events 1
|
5.2%
8/153 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
throat irritation
|
4.1%
6/148 • Number of events 6
|
2.0%
3/153 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Post nasal drip
|
4.7%
7/148 • Number of events 7
|
1.3%
2/153 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place