Trial Outcomes & Findings for Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia (NCT NCT01357356)

NCT ID: NCT01357356

Last Updated: 2020-10-08

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: PHASE2/PHASE3
• Target enrollment: 750 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2020-10-08

Participant Flow

Participant milestones

Measure	SER120 750 ng All participants received SER120 750 ng once daily	SER120 1000 ng All participants received SER120 1000 ng once daily	SER120 1500 ng All participants received SER120 1500 ng once daily	Placebo All participants received Placebo once daily
Overall Study STARTED	188	188	186	188
Overall Study COMPLETED	166	163	158	171
Overall Study NOT COMPLETED	22	25	28	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	SER120 750 ng n=186 Participants All participants received SER120 750 ng once daily	SER120 1000 ng n=183 Participants All participants received SER120 1000 ng once daily	SER120 1500 ng n=179 Participants All participants received SER120 1500 ng once daily	Placebo n=186 Participants All participants received Placebo once daily	Total n=734 Participants Total of all reporting groups
Age, Continuous	66.3 years STANDARD_DEVIATION 9.1 • n=5 Participants	66.1 years STANDARD_DEVIATION 8.9 • n=7 Participants	66.0 years STANDARD_DEVIATION 9.4 • n=5 Participants	66.0 years STANDARD_DEVIATION 10.1 • n=4 Participants	66.1 years STANDARD_DEVIATION 9.3 • n=21 Participants
Sex: Female, Male Female	79 Participants n=5 Participants	74 Participants n=7 Participants	75 Participants n=5 Participants	74 Participants n=4 Participants	302 Participants n=21 Participants
Sex: Female, Male Male	107 Participants n=5 Participants	109 Participants n=7 Participants	104 Participants n=5 Participants	112 Participants n=4 Participants	432 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	17 Participants n=21 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	18 Participants n=7 Participants	20 Participants n=5 Participants	21 Participants n=4 Participants	74 Participants n=21 Participants
Race (NIH/OMB) White	165 Participants n=5 Participants	163 Participants n=7 Participants	152 Participants n=5 Participants	155 Participants n=4 Participants	635 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants
Region of Enrollment United States	171 participants n=5 Participants	171 participants n=7 Participants	160 participants n=5 Participants	175 participants n=4 Participants	677 participants n=21 Participants
Region of Enrollment Canada	15 participants n=5 Participants	12 participants n=7 Participants	19 participants n=5 Participants	11 participants n=4 Participants	57 participants n=21 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

Measure	SER120 750 ng n=186 Participants all participants received SER120 750 ng once daily	SER120 1000 ng n=183 Participants all participants received SER120 1000 ng once daily	SER120 1500 ng n=179 Participants all participants received SER120 1500 ng once daily	Placebo n=186 Participants all participants received placebo once daily
Change in # of Mean Nocturic Episodes Per Night	-1.4 nocturic episodes per night Standard Error 0.07	-1.4 nocturic episodes per night Standard Error 0.07	-1.6 nocturic episodes per night Standard Error 0.07	-1.2 nocturic episodes per night Standard Error 0.07

PRIMARY outcome

Timeframe: 12 weeks

Population: Intent to treat population

Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline

Outcome measures

Measure	SER120 750 ng n=186 Participants all participants received SER120 750 ng once daily	SER120 1000 ng n=183 Participants all participants received SER120 1000 ng once daily	SER120 1500 ng n=179 Participants all participants received SER120 1500 ng once daily	Placebo n=186 Participants all participants received placebo once daily
Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes	77 Participants	73 Participants	93 Participants	61 Participants

Adverse Events

SER120 750 ng

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

SER120 1000 ng

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

SER120 1500 ng

Serious events: 5 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	SER120 750 ng n=188 participants at risk all participants received SER120 750 ng once daily	SER120 1000 ng n=186 participants at risk all participants received SER120 1000 ng once daily	SER120 1500 ng n=184 participants at risk all participants received SER120 1500 ng once daily	Placebo n=187 participants at risk all participants received Placebo once daily
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.53% 1/188 • 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% 0/186 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.	1.1% 2/184 • Number of events 2 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% 0/187 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) Pancreatic carcinoma	0.00% 0/188 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% 0/186 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.	0.54% 1/184 • 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% 0/187 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% 0/188 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% 0/186 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.	0.54% 1/184 • 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.	0.53% 1/187 • 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.
Vascular disorders Hypertension	0.00% 0/188 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% 0/186 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.	0.54% 1/184 • 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% 0/187 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) metastatic squamous cell carcinoma	0.00% 0/188 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% 0/186 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.	0.54% 1/184 • 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% 0/187 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.
Cardiac disorders Cardiac arrest	0.00% 0/188 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.	0.54% 1/186 • 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% 0/184 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% 0/187 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) Colon cancer	0.00% 0/188 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.	0.54% 1/186 • 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% 0/184 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% 0/187 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 Appendicitis	0.00% 0/188 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.	0.54% 1/186 • 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% 0/184 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.	0.53% 1/187 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant	0.53% 1/188 • 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% 0/186 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% 0/184 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% 0/187 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 Presyncope	0.00% 0/188 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% 0/186 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% 0/184 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.	0.53% 1/187 • 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 Joint abscess	0.00% 0/188 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% 0/186 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% 0/184 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.	0.53% 1/187 • 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.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/188 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% 0/186 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% 0/184 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.	0.53% 1/187 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma skin	0.00% 0/188 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% 0/186 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% 0/184 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.	0.53% 1/187 • 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.

Other adverse events

Measure	SER120 750 ng n=188 participants at risk all participants received SER120 750 ng once daily	SER120 1000 ng n=186 participants at risk all participants received SER120 1000 ng once daily	SER120 1500 ng n=184 participants at risk all participants received SER120 1500 ng once daily	Placebo n=187 participants at risk all participants received Placebo once daily
Respiratory, thoracic and mediastinal disorders Nasal discomfort	3.2% 6/188 • Number of events 6 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.	4.8% 9/186 • Number of events 9 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.	6.0% 11/184 • 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.	3.7% 7/187 • 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.
Nervous system disorders Headache	4.3% 8/188 • 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.	2.7% 5/186 • 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.	1.1% 2/184 • Number of events 2 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.	4.3% 8/187 • 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.
Vascular disorders Hypertension	2.1% 4/188 • Number of events 4 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.	0.54% 1/186 • 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.	4.3% 8/184 • 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.	2.1% 4/187 • Number of events 4 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: sfein@serenitypharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place