Trial Outcomes & Findings for A Trial to Investigate Efficacy, Safety and Tolerability of FE 201836 for Nocturia Due to Nocturnal Polyuria in Adults (NCT NCT03201419)

Results Overview

Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning. The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits. Level estimated for baseline value of mean number of nocturnal voids equal to 2, and 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval are presented in this endpoint.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

302 participants

Primary outcome timeframe

Baseline, during 12 weeks of treatment

Results posted on

2022-03-02

Participant Flow

A total of 71 sites were authorized to recruit subjects for the trial between July 2017 and July 2019. The trial sites that screened subjects to the trial were: 5 in Belgium, 10 in Canada, 5 in Czech Republic, 2 in Germany, 5 in Hungary, 1 in Poland and 43 in the Unites States of America (USA).

A total of 1721 subjects were screened, wherein, 531 met the eligibility criteria and entered the enrichment period. Of these, 302 subjects met the eligibility criteria at Visit (V) 4 (randomization), and were randomized to treatment with FE 201836 (different doses), placebo, or desmopressin. A total of 278 subjects completed the trial.

Participant milestones

Participant milestones
Measure	FE 201836 500 µg (Randomized Treatment Period) FE 201836 500 µg oral solution and placebo orally disintegrating tablet (ODT), administered once daily	FE 201836 350 µg (Randomized Treatment Period) FE 201836 350 µg oral solution and placebo ODT, administered once daily	FE 201836 250 µg (Randomized Treatment Period) FE 201836 250 µg oral solution and placebo ODT, administered once daily	FE 201836 150 µg (Randomized Treatment Period) FE 201836 150 µg oral solution and placebo ODT, administered once daily	FE 201836 100 µg (Randomized Treatment Period) FE 201836 100 µg oral solution and placebo ODT, administered once daily	FE 201836 50 µg (Randomized Treatment Period) FE 201836 50 µg oral solution and placebo ODT, administered once daily	Placebo (Randomized Treatment Period) Placebo oral solution and placebo ODT, administered once daily	Desmopressin 25 µg (Randomized Treatment Period) Desmopressin 25 µg ODT and placebo oral solution, administered once daily (female subjects)	Desmopressin 50 µg (Randomized Treatment Period) Desmopressin 50 µg ODT and placebo oral solution, administered once daily (male subjects)
Overall Study STARTED	60	27	24	14	13	34	87	26	17
Overall Study COMPLETED	52	24	22	14	12	33	81	25	15
Overall Study NOT COMPLETED	8	3	2	0	1	1	6	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	FE 201836 500 µg (Randomized Treatment Period) FE 201836 500 µg oral solution and placebo orally disintegrating tablet (ODT), administered once daily	FE 201836 350 µg (Randomized Treatment Period) FE 201836 350 µg oral solution and placebo ODT, administered once daily	FE 201836 250 µg (Randomized Treatment Period) FE 201836 250 µg oral solution and placebo ODT, administered once daily	FE 201836 100 µg (Randomized Treatment Period) FE 201836 100 µg oral solution and placebo ODT, administered once daily	FE 201836 50 µg (Randomized Treatment Period) FE 201836 50 µg oral solution and placebo ODT, administered once daily	Placebo (Randomized Treatment Period) Placebo oral solution and placebo ODT, administered once daily	Desmopressin 25 µg (Randomized Treatment Period) Desmopressin 25 µg ODT and placebo oral solution, administered once daily (female subjects)	Desmopressin 50 µg (Randomized Treatment Period) Desmopressin 50 µg ODT and placebo oral solution, administered once daily (male subjects)
Overall Study Adverse Event	3	1	0	1	1	5	0	0
Overall Study Lost to Follow-up	1	0	0	0	0	0	0	0
Overall Study Protocol Deviation	0	0	0	0	0	1	0	0
Overall Study Withdrawal by Subject	4	2	1	0	0	0	1	2
Overall Study Other	0	0	1	0	0	0	0	0

Baseline Characteristics

Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FE 201836 500 µg (Randomized Treatment Period) n=60 Participants FE 201836 500 µg oral solution and placebo ODT, administered once daily	FE 201836 350 µg (Randomized Treatment Period) n=27 Participants FE 201836 350 µg oral solution and placebo ODT, administered once daily	FE 201836 250 µg (Randomized Treatment Period) n=24 Participants FE 201836 250 µg oral solution and placebo ODT, administered once daily	FE 201836 150 µg (Randomized Treatment Period) n=14 Participants FE 201836 150 µg oral solution and placebo ODT, administered once daily	FE 201836 100 µg (Randomized Treatment Period) n=13 Participants FE 201836 100 µg oral solution and placebo ODT, administered once daily	FE 201836 50 µg (Randomized Treatment Period) n=34 Participants FE 201836 50 µg oral solution and placebo ODT, administered once daily	Placebo (Randomized Treatment Period) n=87 Participants Placebo oral solution and placebo ODT, administered once daily	Desmopressin 25µg (Randomized Treatment Period) n=26 Participants Desmopressin 25 µg ODT and placebo oral solution, administered once daily (female subjects)	Desmopressin 50 µg (Randomized Treatment Period) n=17 Participants Desmopressin 50 µg ODT and placebo oral solution, administered once daily (male subjects)	Total n=302 Participants Total of all reporting groups
Age, Continuous	59.0 years STANDARD_DEVIATION 14.1 • n=60 Participants	58.0 years STANDARD_DEVIATION 14.3 • n=27 Participants	60.8 years STANDARD_DEVIATION 13.0 • n=24 Participants	63.9 years STANDARD_DEVIATION 7.5 • n=14 Participants	61.5 years STANDARD_DEVIATION 9.2 • n=13 Participants	59.1 years STANDARD_DEVIATION 10.4 • n=34 Participants	58.9 years STANDARD_DEVIATION 13.9 • n=87 Participants	51.1 years STANDARD_DEVIATION 11.1 • n=26 Participants	60.9 years STANDARD_DEVIATION 9.5 • n=17 Participants	58.8 years STANDARD_DEVIATION 12.8 • n=302 Participants
Age, Customized <65 years old	35 years n=60 Participants	19 years n=27 Participants	14 years n=24 Participants	6 years n=14 Participants	6 years n=13 Participants	21 years n=34 Participants	52 years n=87 Participants	24 years n=26 Participants	11 years n=17 Participants	188 years n=302 Participants
Age, Customized >=65 years old	25 years n=60 Participants	8 years n=27 Participants	10 years n=24 Participants	8 years n=14 Participants	7 years n=13 Participants	13 years n=34 Participants	35 years n=87 Participants	2 years n=26 Participants	6 years n=17 Participants	114 years n=302 Participants
Sex: Female, Male Female	40 Participants n=60 Participants	18 Participants n=27 Participants	16 Participants n=24 Participants	5 Participants n=14 Participants	8 Participants n=13 Participants	16 Participants n=34 Participants	51 Participants n=87 Participants	26 Participants n=26 Participants	0 Participants n=17 Participants	180 Participants n=302 Participants
Sex: Female, Male Male	20 Participants n=60 Participants	9 Participants n=27 Participants	8 Participants n=24 Participants	9 Participants n=14 Participants	5 Participants n=13 Participants	18 Participants n=34 Participants	36 Participants n=87 Participants	0 Participants n=26 Participants	17 Participants n=17 Participants	122 Participants n=302 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=59 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	9 Participants n=27 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	6 Participants n=24 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	3 Participants n=14 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	7 Participants n=13 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	12 Participants n=34 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	35 Participants n=86 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	12 Participants n=26 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	4 Participants n=17 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	105 Participants n=300 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=59 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	18 Participants n=27 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	18 Participants n=24 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	11 Participants n=14 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	6 Participants n=13 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	22 Participants n=34 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	51 Participants n=86 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	14 Participants n=26 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	13 Participants n=17 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	195 Participants n=300 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=59 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	0 Participants n=27 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	0 Participants n=24 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	0 Participants n=14 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	0 Participants n=13 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	0 Participants n=34 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	0 Participants n=86 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	0 Participants n=26 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	0 Participants n=17 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.	0 Participants n=300 Participants • Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=60 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=27 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=24 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=14 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	1 Participants n=13 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	1 Participants n=33 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	1 Participants n=86 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=26 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=17 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	3 Participants n=300 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.
Race (NIH/OMB) Asian	2 Participants n=60 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=27 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=24 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=14 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=13 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=33 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	2 Participants n=86 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	1 Participants n=26 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=17 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	5 Participants n=300 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=60 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=27 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=24 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=14 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=13 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=33 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=86 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=26 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=17 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=300 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.
Race (NIH/OMB) Black or African American	6 Participants n=60 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	3 Participants n=27 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	2 Participants n=24 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=14 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	1 Participants n=13 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	1 Participants n=33 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	5 Participants n=86 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	6 Participants n=26 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	4 Participants n=17 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	28 Participants n=300 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.
Race (NIH/OMB) White	52 Participants n=60 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	24 Participants n=27 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	22 Participants n=24 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	14 Participants n=14 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	11 Participants n=13 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	31 Participants n=33 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	78 Participants n=86 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	19 Participants n=26 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	13 Participants n=17 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	264 Participants n=300 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.
Race (NIH/OMB) More than one race	0 Participants n=60 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=27 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=24 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=14 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=13 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=33 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=86 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=26 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=17 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=300 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=60 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=27 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=24 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=14 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=13 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=33 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=86 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=26 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=17 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.	0 Participants n=300 Participants • Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.
Baseline body mass index (BMI)	30.66 kg/m^2 STANDARD_DEVIATION 6.05 • n=60 Participants	29.91 kg/m^2 STANDARD_DEVIATION 4.64 • n=27 Participants	29.56 kg/m^2 STANDARD_DEVIATION 6.50 • n=24 Participants	32.03 kg/m^2 STANDARD_DEVIATION 8.26 • n=14 Participants	31.52 kg/m^2 STANDARD_DEVIATION 4.60 • n=13 Participants	30.93 kg/m^2 STANDARD_DEVIATION 6.16 • n=34 Participants	29.54 kg/m^2 STANDARD_DEVIATION 5.14 • n=87 Participants	31.89 kg/m^2 STANDARD_DEVIATION 7.99 • n=26 Participants	31.05 kg/m^2 STANDARD_DEVIATION 6.49 • n=17 Participants	30.44 kg/m^2 STANDARD_DEVIATION 6.00 • n=302 Participants
Mean Number of Nocturnal Voids	2.88 nocturnal voids STANDARD_DEVIATION 0.84 • n=59 Participants • Number analyzed differs from the overall population as baseline mean number of nocturnal voids was not calculated for some of the subjects.	3.01 nocturnal voids STANDARD_DEVIATION 0.72 • n=27 Participants • Number analyzed differs from the overall population as baseline mean number of nocturnal voids was not calculated for some of the subjects.	3.10 nocturnal voids STANDARD_DEVIATION 1.11 • n=24 Participants • Number analyzed differs from the overall population as baseline mean number of nocturnal voids was not calculated for some of the subjects.	2.98 nocturnal voids STANDARD_DEVIATION 0.84 • n=14 Participants • Number analyzed differs from the overall population as baseline mean number of nocturnal voids was not calculated for some of the subjects.	3.33 nocturnal voids STANDARD_DEVIATION 0.82 • n=13 Participants • Number analyzed differs from the overall population as baseline mean number of nocturnal voids was not calculated for some of the subjects.	3.24 nocturnal voids STANDARD_DEVIATION 1.18 • n=34 Participants • Number analyzed differs from the overall population as baseline mean number of nocturnal voids was not calculated for some of the subjects.	3.09 nocturnal voids STANDARD_DEVIATION 0.83 • n=86 Participants • Number analyzed differs from the overall population as baseline mean number of nocturnal voids was not calculated for some of the subjects.	3.38 nocturnal voids STANDARD_DEVIATION 1.45 • n=25 Participants • Number analyzed differs from the overall population as baseline mean number of nocturnal voids was not calculated for some of the subjects.	3.16 nocturnal voids STANDARD_DEVIATION 1.22 • n=17 Participants • Number analyzed differs from the overall population as baseline mean number of nocturnal voids was not calculated for some of the subjects.	3.09 nocturnal voids STANDARD_DEVIATION 0.98 • n=299 Participants • Number analyzed differs from the overall population as baseline mean number of nocturnal voids was not calculated for some of the subjects.
Mean Nocturnal Urine Volume (NUV)	804.6 mL STANDARD_DEVIATION 313.8 • n=58 Participants • Number analyzed differs from the overall population as baseline mean NUV was not calculated for some of the subjects.	766.0 mL STANDARD_DEVIATION 242.1 • n=26 Participants • Number analyzed differs from the overall population as baseline mean NUV was not calculated for some of the subjects.	897.3 mL STANDARD_DEVIATION 373.6 • n=24 Participants • Number analyzed differs from the overall population as baseline mean NUV was not calculated for some of the subjects.	803.1 mL STANDARD_DEVIATION 304.7 • n=14 Participants • Number analyzed differs from the overall population as baseline mean NUV was not calculated for some of the subjects.	892.4 mL STANDARD_DEVIATION 206.7 • n=13 Participants • Number analyzed differs from the overall population as baseline mean NUV was not calculated for some of the subjects.	879.9 mL STANDARD_DEVIATION 354.1 • n=34 Participants • Number analyzed differs from the overall population as baseline mean NUV was not calculated for some of the subjects.	752.3 mL STANDARD_DEVIATION 269.5 • n=86 Participants • Number analyzed differs from the overall population as baseline mean NUV was not calculated for some of the subjects.	839.3 mL STANDARD_DEVIATION 286.4 • n=25 Participants • Number analyzed differs from the overall population as baseline mean NUV was not calculated for some of the subjects.	803.5 mL STANDARD_DEVIATION 425.8 • n=17 Participants • Number analyzed differs from the overall population as baseline mean NUV was not calculated for some of the subjects.	808.8 mL STANDARD_DEVIATION 307.5 • n=297 Participants • Number analyzed differs from the overall population as baseline mean NUV was not calculated for some of the subjects.
Mean Nocturnal Polyuria Index	48.87 percentage STANDARD_DEVIATION 12.04 • n=55 Participants • Number analyzed differs from the overall population as baseline mean nocturnal polyuria index was not calculated for some of the subjects.	46.76 percentage STANDARD_DEVIATION 10.08 • n=25 Participants • Number analyzed differs from the overall population as baseline mean nocturnal polyuria index was not calculated for some of the subjects.	49.75 percentage STANDARD_DEVIATION 15.96 • n=22 Participants • Number analyzed differs from the overall population as baseline mean nocturnal polyuria index was not calculated for some of the subjects.	50.99 percentage STANDARD_DEVIATION 12.93 • n=14 Participants • Number analyzed differs from the overall population as baseline mean nocturnal polyuria index was not calculated for some of the subjects.	44.59 percentage STANDARD_DEVIATION 6.58 • n=12 Participants • Number analyzed differs from the overall population as baseline mean nocturnal polyuria index was not calculated for some of the subjects.	47.01 percentage STANDARD_DEVIATION 9.86 • n=31 Participants • Number analyzed differs from the overall population as baseline mean nocturnal polyuria index was not calculated for some of the subjects.	47.91 percentage STANDARD_DEVIATION 14.29 • n=76 Participants • Number analyzed differs from the overall population as baseline mean nocturnal polyuria index was not calculated for some of the subjects.	49.21 percentage STANDARD_DEVIATION 13.93 • n=23 Participants • Number analyzed differs from the overall population as baseline mean nocturnal polyuria index was not calculated for some of the subjects.	49.10 percentage STANDARD_DEVIATION 17.93 • n=16 Participants • Number analyzed differs from the overall population as baseline mean nocturnal polyuria index was not calculated for some of the subjects.	48.24 percentage STANDARD_DEVIATION 12.99 • n=274 Participants • Number analyzed differs from the overall population as baseline mean nocturnal polyuria index was not calculated for some of the subjects.
Mean Nocturia Impact (NI) Diary Total Score	47.20 score on a scale STANDARD_DEVIATION 18.39 • n=60 Participants • Number analyzed differs from the overall population as mean NI Diary Total Score was not calculated for some of the subjects.	47.03 score on a scale STANDARD_DEVIATION 28.44 • n=26 Participants • Number analyzed differs from the overall population as mean NI Diary Total Score was not calculated for some of the subjects.	38.76 score on a scale STANDARD_DEVIATION 19.09 • n=24 Participants • Number analyzed differs from the overall population as mean NI Diary Total Score was not calculated for some of the subjects.	36.28 score on a scale STANDARD_DEVIATION 22.10 • n=14 Participants • Number analyzed differs from the overall population as mean NI Diary Total Score was not calculated for some of the subjects.	51.63 score on a scale STANDARD_DEVIATION 17.73 • n=13 Participants • Number analyzed differs from the overall population as mean NI Diary Total Score was not calculated for some of the subjects.	42.46 score on a scale STANDARD_DEVIATION 23.28 • n=32 Participants • Number analyzed differs from the overall population as mean NI Diary Total Score was not calculated for some of the subjects.	47.66 score on a scale STANDARD_DEVIATION 21.25 • n=86 Participants • Number analyzed differs from the overall population as mean NI Diary Total Score was not calculated for some of the subjects.	58.06 score on a scale STANDARD_DEVIATION 20.78 • n=25 Participants • Number analyzed differs from the overall population as mean NI Diary Total Score was not calculated for some of the subjects.	39.88 score on a scale STANDARD_DEVIATION 23.08 • n=17 Participants • Number analyzed differs from the overall population as mean NI Diary Total Score was not calculated for some of the subjects.	46.30 score on a scale STANDARD_DEVIATION 21.81 • n=297 Participants • Number analyzed differs from the overall population as mean NI Diary Total Score was not calculated for some of the subjects.
Mean NI Diary Overall Impact Score	59.2 score on a scale STANDARD_DEVIATION 25.4 • n=60 Participants • Number analyzed differs from the overall population as mean NI Diary Overall Impact Score was not calculated for some of the subjects.	62.3 score on a scale STANDARD_DEVIATION 29.8 • n=26 Participants • Number analyzed differs from the overall population as mean NI Diary Overall Impact Score was not calculated for some of the subjects.	55.9 score on a scale STANDARD_DEVIATION 21.6 • n=24 Participants • Number analyzed differs from the overall population as mean NI Diary Overall Impact Score was not calculated for some of the subjects.	53.0 score on a scale STANDARD_DEVIATION 30.6 • n=14 Participants • Number analyzed differs from the overall population as mean NI Diary Overall Impact Score was not calculated for some of the subjects.	68.6 score on a scale STANDARD_DEVIATION 20.7 • n=13 Participants • Number analyzed differs from the overall population as mean NI Diary Overall Impact Score was not calculated for some of the subjects.	59.9 score on a scale STANDARD_DEVIATION 26.8 • n=32 Participants • Number analyzed differs from the overall population as mean NI Diary Overall Impact Score was not calculated for some of the subjects.	62.7 score on a scale STANDARD_DEVIATION 26.8 • n=86 Participants • Number analyzed differs from the overall population as mean NI Diary Overall Impact Score was not calculated for some of the subjects.	71.5 score on a scale STANDARD_DEVIATION 23.8 • n=25 Participants • Number analyzed differs from the overall population as mean NI Diary Overall Impact Score was not calculated for some of the subjects.	54.2 score on a scale STANDARD_DEVIATION 28.0 • n=17 Participants • Number analyzed differs from the overall population as mean NI Diary Overall Impact Score was not calculated for some of the subjects.	61.2 score on a scale STANDARD_DEVIATION 26.3 • n=297 Participants • Number analyzed differs from the overall population as mean NI Diary Overall Impact Score was not calculated for some of the subjects.
Insomnia Severity Index (ISI)	15.8 score on a scale STANDARD_DEVIATION 5.4 • n=55 Participants • Number analyzed differs from the overall population as mean ISI was not calculated for some of the subjects.	15.7 score on a scale STANDARD_DEVIATION 6.1 • n=26 Participants • Number analyzed differs from the overall population as mean ISI was not calculated for some of the subjects.	14.3 score on a scale STANDARD_DEVIATION 5.1 • n=24 Participants • Number analyzed differs from the overall population as mean ISI was not calculated for some of the subjects.	13.0 score on a scale STANDARD_DEVIATION 6.7 • n=14 Participants • Number analyzed differs from the overall population as mean ISI was not calculated for some of the subjects.	16.4 score on a scale STANDARD_DEVIATION 5.6 • n=9 Participants • Number analyzed differs from the overall population as mean ISI was not calculated for some of the subjects.	14.7 score on a scale STANDARD_DEVIATION 4.8 • n=31 Participants • Number analyzed differs from the overall population as mean ISI was not calculated for some of the subjects.	15.6 score on a scale STANDARD_DEVIATION 5.8 • n=77 Participants • Number analyzed differs from the overall population as mean ISI was not calculated for some of the subjects.	18.2 score on a scale STANDARD_DEVIATION 4.7 • n=26 Participants • Number analyzed differs from the overall population as mean ISI was not calculated for some of the subjects.	15.5 score on a scale STANDARD_DEVIATION 6.8 • n=17 Participants • Number analyzed differs from the overall population as mean ISI was not calculated for some of the subjects.	15.6 score on a scale STANDARD_DEVIATION 5.6 • n=279 Participants • Number analyzed differs from the overall population as mean ISI was not calculated for some of the subjects.

PRIMARY outcome

Timeframe: Baseline, during 12 weeks of treatment

Population: The intention-to-treat analysis set for the randomized treatment period (ITT-RT) comprised of all the subjects randomized at Visit 4.

Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning. The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits. Level estimated for baseline value of mean number of nocturnal voids equal to 2, and 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval are presented in this endpoint.