Trial Outcomes & Findings for Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia (NCT NCT01259128)
NCT ID: NCT01259128
Last Updated: 2020-11-17
Results Overview
Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
32 participants
Primary outcome timeframe
baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57
Results posted on
2020-11-17
Participant Flow
Participant milestones
| Measure |
SER120 500 ng
All participants received 500 ng once daily
|
SER120 750 ng
All participants received 750 ng once daily
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
17
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia
Baseline characteristics by cohort
| Measure |
SER120 500 ng
n=15 Participants
All participants received 500 ng once daily
|
SER120 750 ng
n=16 Participants
All participants received 750 ng once daily
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
79 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
79.1 years
STANDARD_DEVIATION 3.3 • n=7 Participants
|
79.1 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57Population: Safety population
Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57.
Outcome measures
| Measure |
SER120 500 ng
n=15 Participants
All participants received 500 ng once daily
|
SER120 750 ng
n=17 Participants
All participants received 750 ng once daily
|
|---|---|---|
|
Serum Sodium Levels at Baseline and During Treatment
Baseline
|
141.0 mmol/L
Standard Deviation 2.4
|
140.0 mmol/L
Standard Deviation 1.7
|
|
Serum Sodium Levels at Baseline and During Treatment
Day 4
|
139.2 mmol/L
Standard Deviation 3.0
|
140.3 mmol/L
Standard Deviation 1.3
|
|
Serum Sodium Levels at Baseline and During Treatment
Day 8
|
139.1 mmol/L
Standard Deviation 3.2
|
140.4 mmol/L
Standard Deviation 1.8
|
|
Serum Sodium Levels at Baseline and During Treatment
Day 15
|
140.4 mmol/L
Standard Deviation 2.1
|
140.2 mmol/L
Standard Deviation 1.4
|
|
Serum Sodium Levels at Baseline and During Treatment
Day 22
|
139.5 mmol/L
Standard Deviation 3.2
|
140.0 mmol/L
Standard Deviation 1.4
|
|
Serum Sodium Levels at Baseline and During Treatment
Day 29
|
139.7 mmol/L
Standard Deviation 2.7
|
139.7 mmol/L
Standard Deviation 2.1
|
|
Serum Sodium Levels at Baseline and During Treatment
Day 43
|
139.9 mmol/L
Standard Deviation 2.7
|
139.6 mmol/L
Standard Deviation 1.5
|
|
Serum Sodium Levels at Baseline and During Treatment
Day 57
|
140.9 mmol/L
Standard Deviation 2.6
|
141.1 mmol/L
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Mean value at Week 8 minus mean value at baselinePopulation: Intent-to-Treat Population
Change in mean nocturic episodes per night between baseline and Week 8
Outcome measures
| Measure |
SER120 500 ng
n=15 Participants
All participants received 500 ng once daily
|
SER120 750 ng
n=16 Participants
All participants received 750 ng once daily
|
|---|---|---|
|
Change in Mean Nocturic Episodes Per Night
|
-1.5 nocturic episodes per night
Standard Deviation 0.8
|
-1.4 nocturic episodes per night
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Intent-To-Treat Polpulation
Percent of participants with greater or equal to 50% reduction in number of nocturic episodes at Week 8 compared to Baseline
Outcome measures
| Measure |
SER120 500 ng
n=15 Participants
All participants received 500 ng once daily
|
SER120 750 ng
n=16 Participants
All participants received 750 ng once daily
|
|---|---|---|
|
Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes
|
11 Participants
|
11 Participants
|
Adverse Events
SER120 500 ng
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
SER120 750 ng
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SER120 500 ng
n=15 participants at risk
All participants received 500 ng once daily
|
SER120 750 ng
n=17 participants at risk
All participants received 750 ng once daily
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Eye disorders
lacrimation increased
|
6.7%
1/15 • Number of events 1 • 8 Weeks
Safety Population
|
11.8%
2/17 • Number of events 2 • 8 Weeks
Safety Population
|
|
Eye disorders
abnormal sensation in eye
|
6.7%
1/15 • Number of events 1 • 8 Weeks
Safety Population
|
0.00%
0/17 • 8 Weeks
Safety Population
|
|
Gastrointestinal disorders
diarrhea
|
13.3%
2/15 • Number of events 2 • 8 Weeks
Safety Population
|
0.00%
0/17 • 8 Weeks
Safety Population
|
|
Gastrointestinal disorders
abdominal pain upper
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Gastrointestinal disorders
chapped lips
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Gastrointestinal disorders
dry mouth
|
6.7%
1/15 • Number of events 1 • 8 Weeks
Safety Population
|
0.00%
0/17 • 8 Weeks
Safety Population
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Gastrointestinal disorders
gingival pain
|
6.7%
1/15 • Number of events 1 • 8 Weeks
Safety Population
|
0.00%
0/17 • 8 Weeks
Safety Population
|
|
Gastrointestinal disorders
hypoaesthesia oral
|
6.7%
1/15 • Number of events 1 • 8 Weeks
Safety Population
|
0.00%
0/17 • 8 Weeks
Safety Population
|
|
Gastrointestinal disorders
oral pain
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
General disorders
Chills
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
General disorders
Pyrexia
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
General disorders
sensation of pressure
|
6.7%
1/15 • Number of events 1 • 8 Weeks
Safety Population
|
0.00%
0/17 • 8 Weeks
Safety Population
|
|
Infections and infestations
nasopharyngitis
|
6.7%
1/15 • Number of events 1 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Injury, poisoning and procedural complications
Joint sprain
|
6.7%
1/15 • Number of events 1 • 8 Weeks
Safety Population
|
0.00%
0/17 • 8 Weeks
Safety Population
|
|
Injury, poisoning and procedural complications
procedural pain
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
6.7%
1/15 • Number of events 1 • 8 Weeks
Safety Population
|
0.00%
0/17 • 8 Weeks
Safety Population
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Nervous system disorders
headache
|
6.7%
1/15 • Number of events 1 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Nervous system disorders
dizziness
|
6.7%
1/15 • Number of events 1 • 8 Weeks
Safety Population
|
0.00%
0/17 • 8 Weeks
Safety Population
|
|
Renal and urinary disorders
urinary hesitation
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
nasal discomfort
|
40.0%
6/15 • Number of events 6 • 8 Weeks
Safety Population
|
35.3%
6/17 • Number of events 6 • 8 Weeks
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
sneezing
|
6.7%
1/15 • Number of events 1 • 8 Weeks
Safety Population
|
23.5%
4/17 • Number of events 4 • 8 Weeks
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhea
|
6.7%
1/15 • Number of events 1 • 8 Weeks
Safety Population
|
11.8%
2/17 • Number of events 2 • 8 Weeks
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
rhinalgia
|
6.7%
1/15 • Number of events 1 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
6.7%
1/15 • Number of events 1 • 8 Weeks
Safety Population
|
0.00%
0/17 • 8 Weeks
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
paranasal sinus discomfort
|
6.7%
1/15 • Number of events 1 • 8 Weeks
Safety Population
|
0.00%
0/17 • 8 Weeks
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
sinus disorder
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
throat irritation
|
6.7%
1/15 • Number of events 1 • 8 Weeks
Safety Population
|
0.00%
0/17 • 8 Weeks
Safety Population
|
|
Skin and subcutaneous tissue disorders
dermatitis contact
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Surgical and medical procedures
sebaceous cyst excision
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
|
Surgical and medical procedures
skin cosmetic procedure
|
0.00%
0/15 • 8 Weeks
Safety Population
|
5.9%
1/17 • Number of events 1 • 8 Weeks
Safety Population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place