Trial Outcomes & Findings for Long Term Safety Assessment of SER120 in Patients With Nocturia (NCT NCT00981682)
NCT ID: NCT00981682
Last Updated: 2021-01-20
Results Overview
Change in mean serum sodium on Day 8, Day 15, Day 22, Week 4, Week 8, Week 12, Week 20, Week 28 and Week 40 compared to Baseline
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
376 participants
Primary outcome timeframe
40 weeks
Results posted on
2021-01-20
Participant Flow
Participant milestones
| Measure |
SER120 750 mcg
All participants received up to 750 mcg SER120 once daily
|
|---|---|
|
Overall Study
STARTED
|
376
|
|
Overall Study
COMPLETED
|
234
|
|
Overall Study
NOT COMPLETED
|
142
|
Reasons for withdrawal
| Measure |
SER120 750 mcg
All participants received up to 750 mcg SER120 once daily
|
|---|---|
|
Overall Study
Adverse Event
|
48
|
|
Overall Study
Withdrawal by Subject
|
52
|
|
Overall Study
Lost to Follow-up
|
14
|
|
Overall Study
Lack of Efficacy
|
13
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
administrative
|
9
|
Baseline Characteristics
Long Term Safety Assessment of SER120 in Patients With Nocturia
Baseline characteristics by cohort
| Measure |
SER120 750 mcg
n=376 Participants
All participants received up to 750 mcg SER120 once daily
|
|---|---|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
126 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
250 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
376 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 40 weeksPopulation: Safety population
Change in mean serum sodium on Day 8, Day 15, Day 22, Week 4, Week 8, Week 12, Week 20, Week 28 and Week 40 compared to Baseline
Outcome measures
| Measure |
SER120 750 mcg
n=376 Participants
All participants received up to 750 mcg SER120 once daily
|
|---|---|
|
Mean Serum Sodium
Day 8
|
-0.0 mmol/L
Standard Deviation 2.3
|
|
Mean Serum Sodium
Day 15
|
-0.4 mmol/L
Standard Deviation 2.3
|
|
Mean Serum Sodium
Day 22
|
-0.4 mmol/L
Standard Deviation 2.5
|
|
Mean Serum Sodium
Week 4
|
-0.3 mmol/L
Standard Deviation 2.2
|
|
Mean Serum Sodium
Week 12
|
-0.5 mmol/L
Standard Deviation 2.6
|
|
Mean Serum Sodium
Week 20
|
-0.4 mmol/L
Standard Deviation 2.6
|
|
Mean Serum Sodium
Week 28
|
-0.8 mmol/L
Standard Deviation 2.4
|
|
Mean Serum Sodium
Week 40
|
-0.6 mmol/L
Standard Deviation 2.6
|
Adverse Events
SER120 750 mcg
Serious events: 30 serious events
Other events: 305 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
SER120 750 mcg
n=376 participants at risk
All participants received up to 750 mcg SER120 once daily
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Cardiac disorders
Cardiovascular disorders
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Cardiac disorders
myocardial infarction
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Cardiac disorders
pericarditis
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Cardiac disorders
sick sinus syndrome
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Cellulitis
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Clostridium difficile colitis
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Infections and infestations
upper respiratory tract infection
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Infections and infestations
urinary tract infection
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Injury, poisoning and procedural complications
multiple injuries
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Injury, poisoning and procedural complications
overdose
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Injury, poisoning and procedural complications
post procedural hemorrhage
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Musculoskeletal and connective tissue disorders
Cervical vertebral fracture
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
0.80%
3/376 • Number of events 3 • 40 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
basal cell carcinoma
|
0.53%
2/376 • Number of events 2 • 40 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
malignant melanoma in situ
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Nervous system disorders
syncope
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Nervous system disorders
Transient ischemic attack
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Psychiatric disorders
alcoholism
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
interstitial lung disease
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Surgical and medical procedures
gastric banding
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Surgical and medical procedures
medical device removal
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Surgical and medical procedures
Uvulopalatopharyngoplasty
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
|
Vascular disorders
hypertension
|
0.27%
1/376 • Number of events 1 • 40 weeks
|
Other adverse events
| Measure |
SER120 750 mcg
n=376 participants at risk
All participants received up to 750 mcg SER120 once daily
|
|---|---|
|
Infections and infestations
Upper respiratory infection
|
6.1%
23/376 • Number of events 23 • 40 weeks
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
20/376 • Number of events 20 • 40 weeks
|
|
Infections and infestations
sinusitis
|
4.5%
17/376 • Number of events 17 • 40 weeks
|
|
Nervous system disorders
headache
|
8.8%
33/376 • Number of events 33 • 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
22.9%
86/376 • Number of events 86 • 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
sneezing
|
12.2%
46/376 • Number of events 46 • 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
11.4%
43/376 • Number of events 43 • 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
5.1%
19/376 • Number of events 19 • 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
4.8%
18/376 • Number of events 18 • 40 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place