Trial Outcomes & Findings for Treatment of Patients With Nocturia (Non-PK Study) (NCT NCT00937378)

NCT ID: NCT00937378

Last Updated: 2020-10-22

Results Overview

Change was calculated as the mean number of nocturic episodes per night between baseline and Week 7

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 326 participants
• Primary outcome timeframe: 7 weeks
• Results posted on: 2020-10-22

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	167	159
Overall Study COMPLETED	149	141
Overall Study NOT COMPLETED	18	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Patients With Nocturia (Non-PK Study)

Baseline characteristics by cohort

Measure	SER120 n=162 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=156 Participants All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration on placebo once daily for the remainder of the study.	Total n=318 Participants Total of all reporting groups
Age, Continuous	64.4 Years STANDARD_DEVIATION 9.1 • n=5 Participants	64.6 Years STANDARD_DEVIATION 8.8 • n=7 Participants	64.5 Years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	57 Participants n=7 Participants	112 Participants n=5 Participants
Sex: Female, Male Male	107 Participants n=5 Participants	99 Participants n=7 Participants	206 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	152 Participants n=5 Participants	145 Participants n=7 Participants	297 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 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	162 participants n=5 Participants	156 participants n=7 Participants	318 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 weeks

Population: Intent-to-treat

Change was calculated as the mean number of nocturic episodes per night between baseline and Week 7

Outcome measures

Measure	SER120 n=162 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=156 Participants 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.
Change in Mean Number of Nocturic Episodes/Night	-1.3 nocturic episodes per night Standard Deviation 0.8	-1.2 nocturic episodes per night Standard Deviation 0.8

PRIMARY outcome

Timeframe: 7 weeks

Population: 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=162 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=156 Participants 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.
Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night	83 Participants	64 Participants

Adverse Events

SER120

Serious events: 3 serious events

Other events: 112 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 102 other events

Deaths: 0 deaths

Serious adverse events

Measure	SER120 n=167 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=159 participants at risk All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration on placebo once daily for the remainder of the study.
Cardiac disorders Coronary artery disease	0.60% 1/167 • Number of events 1 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).	0.00% 0/159 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).
Hepatobiliary disorders Cholelithiasis	0.00% 0/167 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).	0.63% 1/159 • Number of events 1 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).
Infections and infestations Celulitis	0.60% 1/167 • Number of events 1 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).	0.00% 0/159 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).
Infections and infestations diverticulitis	0.60% 1/167 • Number of events 1 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).	0.00% 0/159 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ovarian cancer	0.00% 0/167 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).	0.63% 1/159 • Number of events 1 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).

Other adverse events

Measure	SER120 n=167 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=159 participants at risk All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration on placebo once daily for the remainder of the study.
Eye disorders Lacrimation increased	6.6% 11/167 • Number of events 11 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).	6.3% 10/159 • Number of events 10 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).
Nervous system disorders Headache	7.8% 13/167 • Number of events 13 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).	3.8% 6/159 • Number of events 6 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).
Respiratory, thoracic and mediastinal disorders Nasal discomfort	31.7% 53/167 • Number of events 53 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).	30.2% 48/159 • Number of events 48 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).
Respiratory, thoracic and mediastinal disorders sneezing	14.4% 24/167 • Number of events 24 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).	17.0% 27/159 • Number of events 27 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).
Respiratory, thoracic and mediastinal disorders Rhinorrhea	12.0% 20/167 • Number of events 20 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).	10.1% 16/159 • Number of events 16 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).
Respiratory, thoracic and mediastinal disorders Nasal Congestion	6.0% 10/167 • Number of events 10 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).	5.0% 8/159 • Number of events 8 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).
Respiratory, thoracic and mediastinal disorders oropharyngeal pain	2.4% 4/167 • Number of events 4 Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).	4.4% 7/159 • Number of events 7 Safety Population (only on participants who had received at least 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