Trial Outcomes & Findings for Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4 (NCT NCT01900704)

NCT ID: NCT01900704

Last Updated: 2020-11-09

Results Overview

Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

810 participants

Primary outcome timeframe

12 weeks

Results posted on

2020-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	SER120 1500 ng All participants received SER120 1500 ng once daily	SER120 750 ng All participant received SER120 750 ng once daily	Placebo All participants received Placebo once daily
Overall Study STARTED	270	270	270
Overall Study COMPLETED	229	235	237
Overall Study NOT COMPLETED	41	35	33

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SER120 750 ng n=262 Participants All participants received SER120 750 ng once daily	SER120 1500 ng n=260 Participants All participants received SER120 1500 ng once daily	Placebo n=260 Participants All participants received Placebo once daily	Total n=782 Participants Total of all reporting groups
Age, Continuous	66.5 years STANDARD_DEVIATION 8.8 • n=99 Participants	66.1 years STANDARD_DEVIATION 9.2 • n=107 Participants	65.8 years STANDARD_DEVIATION 9.0 • n=206 Participants	66.1 years STANDARD_DEVIATION 9.0 • n=7 Participants
Sex: Female, Male Female	117 Participants n=99 Participants	113 Participants n=107 Participants	114 Participants n=206 Participants	344 Participants n=7 Participants
Sex: Female, Male Male	145 Participants n=99 Participants	147 Participants n=107 Participants	146 Participants n=206 Participants	438 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	4 Participants n=99 Participants	6 Participants n=107 Participants	1 Participants n=206 Participants	11 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	26 Participants n=99 Participants	40 Participants n=107 Participants	39 Participants n=206 Participants	105 Participants n=7 Participants
Race (NIH/OMB) White	229 Participants n=99 Participants	212 Participants n=107 Participants	220 Participants n=206 Participants	661 Participants n=7 Participants
Race (NIH/OMB) More than one race	3 Participants n=99 Participants	2 Participants n=107 Participants	0 Participants n=206 Participants	5 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Region of Enrollment United States	247 participants n=99 Participants	238 participants n=107 Participants	249 participants n=206 Participants	734 participants n=7 Participants
Region of Enrollment Canada	15 participants n=99 Participants	22 participants n=107 Participants	11 participants n=206 Participants	48 participants n=7 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: intent to treat population

Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12

Outcome measures

Outcome measures
Measure	SER120 750 ng n=262 Participants All participants received SER120 750 ng once daily	SER120 1500 ng n=260 Participants All participants received SER120 1500 ng once daily	Placebo n=260 Participants All participants received Placebo once daily
Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment	-1.4 nocturic episodes per night Standard Error 0.06	-1.5 nocturic episodes per night Standard Error 0.06	-1.2 nocturic episodes per night Standard Error 0.06

PRIMARY outcome

Timeframe: 12 weeks

Population: Intent to treat population

Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period

Outcome measures

Outcome measures
Measure	SER120 750 ng n=262 Participants All participants received SER120 750 ng once daily	SER120 1500 ng n=260 Participants All participants received SER120 1500 ng once daily	Placebo n=260 Participants All participants received Placebo once daily
Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes	93 Participants	121 Participants	74 Participants

Adverse Events

SER120 750 ng

Serious events: 7 serious events

Other events: 30 other events

Deaths: 0 deaths

SER120 1500 ng

Serious events: 4 serious events

Other events: 30 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	SER120 750 ng n=266 participants at risk All participants received SER120 750 ng once daily	SER120 1500 ng n=264 participants at risk All participants received SER120 1500 ng once daily	Placebo n=267 participants at risk All participants received Placebo once daily
Respiratory, thoracic and mediastinal disorders Nasal discomfort	3.8% 10/266 • Number of events 10 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	5.3% 14/264 • Number of events 14 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	6.7% 18/267 • Number of events 18 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
Infections and infestations Urinary tract infection	4.5% 12/266 • Number of events 12 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	1.9% 5/264 • Number of events 5 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	1.9% 5/267 • Number of events 5 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
Nervous system disorders Headache	3.0% 8/266 • Number of events 8 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	4.2% 11/264 • Number of events 11 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	2.6% 7/267 • Number of events 7 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.

Additional Information

Chief Medical Officer

Serenity Pharmaceuticals

Phone: 8456396760

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	SER120 750 ng n=266 participants at risk All participants received SER120 750 ng once daily	SER120 1500 ng n=264 participants at risk All participants received SER120 1500 ng once daily	Placebo n=267 participants at risk All participants received Placebo once daily
Cardiac disorders Cardiac Failure Congestive	0.38% 1/266 • Number of events 1 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/264 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/267 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
Gastrointestinal disorders Crohn's disease	0.38% 1/266 • Number of events 1 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/264 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/267 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.38% 1/266 • Number of events 1 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/264 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/267 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
General disorders Chest pain	0.00% 0/266 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/264 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.37% 1/267 • Number of events 1 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
General disorders Death	0.38% 1/266 • Number of events 1 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/264 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/267 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
Infections and infestations Abscess limb	0.38% 1/266 • Number of events 1 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/264 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/267 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
Infections and infestations Gallbladder empyema	0.00% 0/266 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/264 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.37% 1/267 • Number of events 1 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
Infections and infestations Pneumonia	0.00% 0/266 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.38% 1/264 • Number of events 1 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/267 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
Infections and infestations Upper respiratory tract infection	0.38% 1/266 • Number of events 1 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/264 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/267 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
Injury, poisoning and procedural complications Radius fracture	0.38% 1/266 • Number of events 1 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/264 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/267 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/266 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.38% 1/264 • Number of events 1 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.37% 1/267 • Number of events 1 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/266 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.38% 1/264 • Number of events 1 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/267 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.00% 0/266 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.38% 1/264 • Number of events 1 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/267 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma skin	0.00% 0/266 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/264 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.37% 1/267 • Number of events 1 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.38% 1/266 • Number of events 1 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/264 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/267 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/266 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.00% 0/264 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.	0.37% 1/267 • Number of events 1 Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.