Trial Outcomes & Findings for Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia (NCT NCT00477490)
NCT ID: NCT00477490
Last Updated: 2015-11-02
Results Overview
The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Day 1 and prior to the week 4 visit as recorded in participant diaries. This was the first co-primary outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
799 participants
Primary outcome timeframe
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Results posted on
2015-11-02
Participant Flow
Eighty-eight (88) sites were initiated in the United States and Canada, and 81 of these sites screened subjects; 78 sites enrolled and randomized subjects. A total of 1412 subjects were screened for Part I of the study; 613 subjects were screening failures.
Potential subjects were given a sleep/voiding diary and urine collection device to record the time and volume of each void for 3 consecutive 24-hour periods. Randomization was stratified by age (\<65, ≥65 years) and by the absence/presence of nocturnal polyuria, defined as a ratio of nighttime urine volume/24-hour urine volume ≥33%.
Participant milestones
| Measure |
Placebo
Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 10 μg
Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 25 μg
Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 50 μg
Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 100 μg
Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Placebo to 10 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
|
Placebo to 25 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
|
Placebo to 50 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
|
Placebo to 100 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part I: 4 Week Efficacy
STARTED
|
160
|
163
|
158
|
158
|
160
|
0
|
0
|
0
|
0
|
|
Part I: 4 Week Efficacy
ITT Population
|
156
|
155
|
152
|
148
|
146
|
0
|
0
|
0
|
0
|
|
Part I: 4 Week Efficacy
COMPLETED
|
145
|
144
|
148
|
138
|
135
|
0
|
0
|
0
|
0
|
|
Part I: 4 Week Efficacy
NOT COMPLETED
|
15
|
19
|
10
|
20
|
25
|
0
|
0
|
0
|
0
|
|
Part II: Extension Week 5 up to Day 169
STARTED
|
0
|
135
|
135
|
132
|
127
|
31
|
37
|
34
|
34
|
|
Part II: Extension Week 5 up to Day 169
COMPLETED
|
0
|
107
|
120
|
120
|
107
|
25
|
32
|
29
|
26
|
|
Part II: Extension Week 5 up to Day 169
NOT COMPLETED
|
0
|
28
|
15
|
12
|
20
|
6
|
5
|
5
|
8
|
Reasons for withdrawal
| Measure |
Placebo
Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 10 μg
Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 25 μg
Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 50 μg
Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 100 μg
Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Placebo to 10 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
|
Placebo to 25 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
|
Placebo to 50 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
|
Placebo to 100 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part I: 4 Week Efficacy
Adverse Event
|
1
|
4
|
0
|
5
|
6
|
0
|
0
|
0
|
0
|
|
Part I: 4 Week Efficacy
Serum Sodium <= 125mmol/L
|
1
|
0
|
0
|
5
|
4
|
0
|
0
|
0
|
0
|
|
Part I: 4 Week Efficacy
Protocol Violation
|
2
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part I: 4 Week Efficacy
Withdrawal by Subject
|
6
|
5
|
6
|
4
|
9
|
0
|
0
|
0
|
0
|
|
Part I: 4 Week Efficacy
Lost to Follow-up
|
2
|
4
|
1
|
5
|
3
|
0
|
0
|
0
|
0
|
|
Part I: 4 Week Efficacy
Other, not specified
|
2
|
4
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Part I: 4 Week Efficacy
Not Reported
|
1
|
2
|
3
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part II: Extension Week 5 up to Day 169
Withdrawal by Subject
|
0
|
15
|
7
|
7
|
10
|
4
|
2
|
3
|
2
|
|
Part II: Extension Week 5 up to Day 169
Adverse Event
|
0
|
2
|
3
|
1
|
1
|
1
|
1
|
1
|
4
|
|
Part II: Extension Week 5 up to Day 169
Lost to Follow-up
|
0
|
3
|
2
|
0
|
5
|
0
|
1
|
0
|
0
|
|
Part II: Extension Week 5 up to Day 169
Decreased sodium
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
|
Part II: Extension Week 5 up to Day 169
Excluded medication
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part II: Extension Week 5 up to Day 169
Other, not specified
|
0
|
4
|
2
|
4
|
2
|
1
|
1
|
0
|
1
|
|
Part II: Extension Week 5 up to Day 169
Not reported
|
0
|
3
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia
Baseline characteristics by cohort
| Measure |
Placebo
n=156 Participants
Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
|
Desmopressin Melt 10 μg
n=155 Participants
Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 25 μg
n=152 Participants
Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 50 μg
n=148 Participants
Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 100 μg
n=146 Participants
Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Total
n=757 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 13.39 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 14.41 • n=7 Participants
|
62.4 years
STANDARD_DEVIATION 13.22 • n=5 Participants
|
61.6 years
STANDARD_DEVIATION 11.80 • n=4 Participants
|
62.1 years
STANDARD_DEVIATION 12.34 • n=21 Participants
|
62.0 years
STANDARD_DEVIATION 13.05 • n=8 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
341 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
416 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
136 participants
n=5 Participants
|
123 participants
n=7 Participants
|
120 participants
n=5 Participants
|
119 participants
n=4 Participants
|
111 participants
n=21 Participants
|
609 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
16 participants
n=5 Participants
|
21 participants
n=7 Participants
|
28 participants
n=5 Participants
|
24 participants
n=4 Participants
|
27 participants
n=21 Participants
|
116 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
6 participants
n=21 Participants
|
16 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
12 participants
n=8 Participants
|
|
Ethnic Origin
Hispanic
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
13 participants
n=4 Participants
|
6 participants
n=21 Participants
|
52 participants
n=8 Participants
|
|
Ethnic Origin
Not Hispanic
|
143 participants
n=5 Participants
|
145 participants
n=7 Participants
|
142 participants
n=5 Participants
|
135 participants
n=4 Participants
|
140 participants
n=21 Participants
|
705 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)Population: Intent to treat (ITT) population --All randomized participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., nocturnal voids) during Part I were included in the ITT analysis dataset
The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Day 1 and prior to the week 4 visit as recorded in participant diaries. This was the first co-primary outcome.
Outcome measures
| Measure |
Placebo
n=156 Participants
Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
|
Desmopressin Melt 10 μg
n=155 Participants
Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 25 μg
n=152 Participants
Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 50 μg
n=148 Participants
Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 100 μg
n=146 Participants
Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Placebo to 25 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
|
Placebo to 50 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
|
Placebo to 100 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
|
|---|---|---|---|---|---|---|---|---|
|
Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4
|
-0.86 nocturnal voids
Standard Deviation 1.054
|
-0.83 nocturnal voids
Standard Deviation 1.069
|
-1.00 nocturnal voids
Standard Deviation 1.125
|
-1.18 nocturnal voids
Standard Deviation 1.187
|
-1.43 nocturnal voids
Standard Deviation 1.219
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)Population: Intent to treat (ITT) population --All randomized participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., nocturnal voids) during Part I were included in the ITT analysis dataset
Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to the end of Part I (week 4) in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries. This was the second co-primary outcome.
Outcome measures
| Measure |
Placebo
n=156 Participants
Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
|
Desmopressin Melt 10 μg
n=155 Participants
Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 25 μg
n=152 Participants
Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 50 μg
n=148 Participants
Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 100 μg
n=146 Participants
Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Placebo to 25 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
|
Placebo to 50 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
|
Placebo to 100 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
|
|---|---|---|---|---|---|---|---|---|
|
Part I: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids at Week 4
|
47 percentage of participants
|
47 percentage of participants
|
50 percentage of participants
|
53 percentage of participants
|
71 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: - Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169Population: Observed Cases (OC) Analysis Set which consisted of participants who had information on mean number of nocturnal voids for both the screening visit and the final visit in Part I (Day 28) and did not have any major protocol deviations.
Part II outcomes tested the durability of the effect observed in Part I. The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Part I baseline and prior to the Part II visit as recorded in participant diaries.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
|
Desmopressin Melt 10 μg
n=100 Participants
Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 25 μg
n=93 Participants
Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 50 μg
n=104 Participants
Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 100 μg
n=22 Participants
Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Placebo to 25 μg
n=28 Participants
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
|
Placebo to 50 μg
n=27 Participants
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
|
Placebo to 100 μg
n=22 Participants
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
|
|---|---|---|---|---|---|---|---|---|
|
Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Day 29 (n=104,100,93,104,22,28,27,22)
|
-1.12 nocturnal voids
Standard Deviation 1.161
|
-1.31 nocturnal voids
Standard Deviation 1.163
|
-1.43 nocturnal voids
Standard Deviation 1.273
|
-1.47 nocturnal voids
Standard Deviation 1.080
|
-1.20 nocturnal voids
Standard Deviation 0.912
|
-1.19 nocturnal voids
Standard Deviation 1.215
|
-1.00 nocturnal voids
Standard Deviation 1.140
|
-1.58 nocturnal voids
Standard Deviation 1.169
|
|
Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Day 57 (n=86,85,78,81,17,24,21,16)
|
-1.14 nocturnal voids
Standard Deviation 1.147
|
-1.42 nocturnal voids
Standard Deviation 1.231
|
-1.50 nocturnal voids
Standard Deviation 1.156
|
-1.74 nocturnal voids
Standard Deviation 1.036
|
-1.08 nocturnal voids
Standard Deviation 0.618
|
-1.53 nocturnal voids
Standard Deviation 1.183
|
-1.03 nocturnal voids
Standard Deviation 1.264
|
-1.35 nocturnal voids
Standard Deviation 1.363
|
|
Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Day 113 (n=53,56,49,47,11,15,13,11)
|
-1.31 nocturnal voids
Standard Deviation 1.195
|
-1.56 nocturnal voids
Standard Deviation 1.158
|
-1.65 nocturnal voids
Standard Deviation 1,279
|
-1.95 nocturnal voids
Standard Deviation 1.088
|
-0.76 nocturnal voids
Standard Deviation 0.870
|
-1.67 nocturnal voids
Standard Deviation 1.039
|
-1.21 nocturnal voids
Standard Deviation 1.085
|
-1.76 nocturnal voids
Standard Deviation 1.193
|
|
Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Day 169 (n=17,15,17,15,3,3,4,2)
|
-1.47 nocturnal voids
Standard Deviation 1.537
|
-1.71 nocturnal voids
Standard Deviation 1.214
|
-1.65 nocturnal voids
Standard Deviation 0.916
|
-1.76 nocturnal voids
Standard Deviation 0.801
|
-1.78 nocturnal voids
Standard Deviation 0.192
|
-2.00 nocturnal voids
Standard Deviation 2.000
|
-2.33 nocturnal voids
Standard Deviation 0.272
|
-2.50 nocturnal voids
Standard Deviation 1.179
|
SECONDARY outcome
Timeframe: - Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169Population: Observed Cases (OC) Analysis Set which consisted of participants who had information on mean number of nocturnal voids for both the screening visit and the final visit in Part I (Day 28) and did not have any major protocol deviations. Participants had data representing the visit.
Part II outcomes tested the durability of the effect observed in Part I. Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to Days 29, 57, 113 and 169 in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
|
Desmopressin Melt 10 μg
n=100 Participants
Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 25 μg
n=93 Participants
Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 50 μg
n=104 Participants
Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 100 μg
n=22 Participants
Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Placebo to 25 μg
n=28 Participants
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
|
Placebo to 50 μg
n=27 Participants
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
|
Placebo to 100 μg
n=22 Participants
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
|
|---|---|---|---|---|---|---|---|---|
|
Part II: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Day 29 (n=104,100,93,104,22,28,27,22)
|
57 percentage of participants
|
64 percentage of participants
|
68 percentage of participants
|
68 percentage of participants
|
73 percentage of participants
|
43 percentage of participants
|
48 percentage of participants
|
73 percentage of participants
|
|
Part II: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Day 57 (n=86,85,78,81,17,24,21,16)
|
59 percentage of participants
|
68 percentage of participants
|
71 percentage of participants
|
83 percentage of participants
|
41 percentage of participants
|
71 percentage of participants
|
43 percentage of participants
|
69 percentage of participants
|
|
Part II: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Day 113 (n=53,56,49,47,11,15,13,11)
|
58 percentage of participants
|
79 percentage of participants
|
69 percentage of participants
|
87 percentage of participants
|
55 percentage of participants
|
73 percentage of participants
|
54 percentage of participants
|
73 percentage of participants
|
|
Part II: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Day 169 (n=17,15,17,15,3,3,4,2)
|
61 percentage of participants
|
80 percentage of participants
|
76 percentage of participants
|
87 percentage of participants
|
100 percentage of participants
|
67 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)Population: Intent to treat (ITT) population --All randomized subjects who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids) during Part I were included in the ITT analysis dataset. Participants analyzed had baseline and Week 4/Day 28/End of Part 1 measurements.
Total sleep time was recorded by participants in study diaries.
Outcome measures
| Measure |
Placebo
n=139 Participants
Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
|
Desmopressin Melt 10 μg
n=137 Participants
Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 25 μg
n=141 Participants
Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 50 μg
n=138 Participants
Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 100 μg
n=133 Participants
Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Placebo to 25 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
|
Placebo to 50 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
|
Placebo to 100 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
|
|---|---|---|---|---|---|---|---|---|
|
Part I: Change From Baseline in Total Reported Sleep Time at Week 4
|
24.6 minutes
Standard Deviation 80.66
|
7.8 minutes
Standard Deviation 58.55
|
15.9 minutes
Standard Deviation 53.92
|
24.9 minutes
Standard Deviation 72.21
|
19.0 minutes
Standard Deviation 68.94
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)Population: ITT population --All randomized subjects who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids) during Part I were included in the ITT analysis dataset. Participants with both baseline and Week 4/Day 28/End of Part I data are included.
Initial period of undisturbed sleep was the time elapsed from first falling asleep until either first void or morning arising. Data were captured in patient diaries.
Outcome measures
| Measure |
Placebo
n=126 Participants
Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
|
Desmopressin Melt 10 μg
n=126 Participants
Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 25 μg
n=121 Participants
Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 50 μg
n=123 Participants
Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 100 μg
n=121 Participants
Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Placebo to 25 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
|
Placebo to 50 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
|
Placebo to 100 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
|
|---|---|---|---|---|---|---|---|---|
|
Part I: Change From Baseline in Initial Period of Undisturbed Sleep at Week 4
|
38.7 minutes
Standard Deviation 88.79
|
50.9 minutes
Standard Deviation 111.47
|
82.7 minutes
Standard Deviation 105.57
|
85.1 minutes
Standard Deviation 109.33
|
106.7 minutes
Standard Deviation 116.18
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)Population: Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.
The ICIQ-N is a self-administered questionnaire designed to assess the frequency and bother of daytime and nighttime urination. Subjects were asked to rate the degree of bother of daytime urination and nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower quality of life.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
|
Desmopressin Melt 10 μg
n=145 Participants
Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 25 μg
n=143 Participants
Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 50 μg
n=137 Participants
Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 100 μg
n=137 Participants
Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Placebo to 25 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
|
Placebo to 50 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
|
Placebo to 100 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
|
|---|---|---|---|---|---|---|---|---|
|
Part I: Change From Baseline in Quality of Life Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) at Week 4
Daytime urination: How much does it bother you?
|
-0.7 units on a scale
Standard Deviation 2.61
|
-0.7 units on a scale
Standard Deviation 2.59
|
-0.9 units on a scale
Standard Deviation 2.96
|
-0.7 units on a scale
Standard Deviation 2.86
|
-1.0 units on a scale
Standard Deviation 2.90
|
—
|
—
|
—
|
|
Part I: Change From Baseline in Quality of Life Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) at Week 4
Nighttime urination: How much does it bother you?
|
-1.4 units on a scale
Standard Deviation 2.86
|
-1.8 units on a scale
Standard Deviation 2.96
|
-2.1 units on a scale
Standard Deviation 3.19
|
-2.2 units on a scale
Standard Deviation 3.33
|
-2.5 units on a scale
Standard Deviation 3.32
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)Population: Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.
The NQoL questionnaire is a self-administered questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The twelve core questions are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. Domain summary scores were calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better quality of life.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
|
Desmopressin Melt 10 μg
n=148 Participants
Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 25 μg
n=145 Participants
Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 50 μg
n=135 Participants
Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 100 μg
n=138 Participants
Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Placebo to 25 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
|
Placebo to 50 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
|
Placebo to 100 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
|
|---|---|---|---|---|---|---|---|---|
|
Part I: Change From Baseline in the Two Domain Scores of the Nocturia Quality of Life (NQoL) Questionnaire at Week 4
Sleep/Energy Domain
|
15.2 units on a scale
Standard Deviation 19.30
|
12.3 units on a scale
Standard Deviation 23.54
|
14.6 units on a scale
Standard Deviation 18.71
|
14.7 units on a scale
Standard Deviation 20.92
|
16.3 units on a scale
Standard Deviation 21.09
|
—
|
—
|
—
|
|
Part I: Change From Baseline in the Two Domain Scores of the Nocturia Quality of Life (NQoL) Questionnaire at Week 4
Bother/Concern Domain
|
12.7 units on a scale
Standard Deviation 19.73
|
14.7 units on a scale
Standard Deviation 23.42
|
15.7 units on a scale
Standard Deviation 21.29
|
15.2 units on a scale
Standard Deviation 25.46
|
18.2 units on a scale
Standard Deviation 23.29
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)Population: Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.
The PSQI is a self-administered 19-item questionnaire designed to assess sleep quality and disturbances. The global score ranges from 0 (better sleep quality) to 21 (worse sleep quality). Higher numbers indicate lower quality of life.
Outcome measures
| Measure |
Placebo
n=143 Participants
Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
|
Desmopressin Melt 10 μg
n=138 Participants
Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 25 μg
n=136 Participants
Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 50 μg
n=129 Participants
Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 100 μg
n=132 Participants
Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Placebo to 25 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
|
Placebo to 50 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
|
Placebo to 100 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
|
|---|---|---|---|---|---|---|---|---|
|
Part I: Change From Baseline in Quality of Sleep as Assessed by the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Week 4
|
-1.6 units on a scale
Standard Deviation 2.8
|
-1.6 units on a scale
Standard Deviation 2.8
|
-1.8 units on a scale
Standard Deviation 3.0
|
-2.0 units on a scale
Standard Deviation 3.2
|
-1.9 units on a scale
Standard Deviation 3.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)Population: Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.
The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions. Data were analyzed using norm-based scoring and summarized along 2 dimensions: Physical Health Summary and Mental Health Summary. Each summary has a range from 0 (poor health) to 100 (highest level of health). Higher numbers indicate better quality of life.
Outcome measures
| Measure |
Placebo
n=146 Participants
Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
|
Desmopressin Melt 10 μg
n=146 Participants
Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 25 μg
n=140 Participants
Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 50 μg
n=137 Participants
Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 100 μg
n=137 Participants
Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Placebo to 25 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
|
Placebo to 50 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
|
Placebo to 100 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
|
|---|---|---|---|---|---|---|---|---|
|
Part I: Change From Baseline in the Mental Health Summary and the Physical Health Summary of the Short Form-12 Version 2 (SF-12v2) at Week 4
Mental Health Summary
|
2.4 units on a scale
Standard Deviation 7.98
|
2.5 units on a scale
Standard Deviation 8.06
|
2.1 units on a scale
Standard Deviation 8.16
|
2.2 units on a scale
Standard Deviation 8.39
|
1.7 units on a scale
Standard Deviation 7.73
|
—
|
—
|
—
|
|
Part I: Change From Baseline in the Mental Health Summary and the Physical Health Summary of the Short Form-12 Version 2 (SF-12v2) at Week 4
Physical Health Summary
|
1.0 units on a scale
Standard Deviation 6.81
|
0.5 units on a scale
Standard Deviation 6.89
|
1.2 units on a scale
Standard Deviation 7.17
|
0.6 units on a scale
Standard Deviation 7.10
|
2.3 units on a scale
Standard Deviation 6.62
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Week 4 (end of Part I)Population: Part I Safety Population includes study participants who received study intervention and had at least one safety assessment during study Part I.
A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period.
Outcome measures
| Measure |
Placebo
n=160 Participants
Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
|
Desmopressin Melt 10 μg
n=163 Participants
Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 25 μg
n=158 Participants
Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 50 μg
n=158 Participants
Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 100 μg
n=160 Participants
Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Placebo to 25 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
|
Placebo to 50 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
|
Placebo to 100 μg
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
|
|---|---|---|---|---|---|---|---|---|
|
Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I
All AEs
|
94 participants
|
100 participants
|
98 participants
|
103 participants
|
110 participants
|
—
|
—
|
—
|
|
Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I
Deaths
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I
Serious AEs
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
—
|
—
|
—
|
|
Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I
AEs leading to discontinuation
|
8 participants
|
6 participants
|
2 participants
|
13 participants
|
13 participants
|
—
|
—
|
—
|
|
Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I
Severe AEs
|
4 participants
|
8 participants
|
5 participants
|
13 participants
|
7 participants
|
—
|
—
|
—
|
|
Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I
Adverse drug reactions (ADRs)
|
62 participants
|
62 participants
|
61 participants
|
73 participants
|
80 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 5 up to Day 169Population: Part II Safety Population includes study participants who received study intervention and had at least one safety assessment during study Part II.
A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period.
Outcome measures
| Measure |
Placebo
n=135 Participants
Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
|
Desmopressin Melt 10 μg
n=135 Participants
Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 25 μg
n=132 Participants
Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 50 μg
n=127 Participants
Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Desmopressin Melt 100 μg
n=31 Participants
Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Placebo to 25 μg
n=37 Participants
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
|
Placebo to 50 μg
n=34 Participants
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
|
Placebo to 100 μg
n=34 Participants
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
|
|---|---|---|---|---|---|---|---|---|
|
Part II: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part II
Adverse Drug Reactions
|
64 participants
|
59 participants
|
58 participants
|
68 participants
|
10 participants
|
16 participants
|
15 participants
|
18 participants
|
|
Part II: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part II
All AEs
|
95 participants
|
95 participants
|
92 participants
|
100 participants
|
20 participants
|
27 participants
|
25 participants
|
28 participants
|
|
Part II: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part II
Deaths
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Part II: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part II
Serious AEs
|
3 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
|
Part II: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part II
AEs leading to discontinuation
|
3 participants
|
3 participants
|
2 participants
|
4 participants
|
1 participants
|
2 participants
|
2 participants
|
5 participants
|
|
Part II: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part II
Severe AEs
|
7 participants
|
4 participants
|
9 participants
|
5 participants
|
1 participants
|
3 participants
|
2 participants
|
1 participants
|
Adverse Events
Part I: Placebo
Serious events: 1 serious events
Other events: 64 other events
Deaths: 0 deaths
Part I: Desmopressin Melt 10 μg
Serious events: 2 serious events
Other events: 67 other events
Deaths: 0 deaths
Part I: Desmopressin Melt 25 μg
Serious events: 1 serious events
Other events: 62 other events
Deaths: 0 deaths
Part I: Desmopressin Melt 50 μg
Serious events: 2 serious events
Other events: 76 other events
Deaths: 0 deaths
Part I: Desmopressin Melt 100 μg
Serious events: 0 serious events
Other events: 79 other events
Deaths: 0 deaths
Part II: Desmopressin Melt 10 μg
Serious events: 3 serious events
Other events: 71 other events
Deaths: 0 deaths
Part II: Desmopressin Melt 25 μg
Serious events: 1 serious events
Other events: 69 other events
Deaths: 0 deaths
Part II: Desmopressin Melt 50 μg
Serious events: 0 serious events
Other events: 66 other events
Deaths: 0 deaths
Part II: Desmopressin Melt 100 μg
Serious events: 2 serious events
Other events: 73 other events
Deaths: 0 deaths
Part II: Placebo to Desmopressin Melt 10 μg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Part II: Placebo to Desmopressin Melt 25 μg
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Part II: Placebo to Desmopressin Melt 50 μg
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Part II: Placebo to Desmopressin Melt 100 μg
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part I: Placebo
n=160 participants at risk
Participants took a placebo 'melt' for 28 days to complete Part I of the study.
|
Part I: Desmopressin Melt 10 μg
n=163 participants at risk
Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study.
|
Part I: Desmopressin Melt 25 μg
n=158 participants at risk
Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study.
|
Part I: Desmopressin Melt 50 μg
n=158 participants at risk
Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study.
|
Part I: Desmopressin Melt 100 μg
n=160 participants at risk
Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Part II: Desmopressin Melt 10 μg
n=135 participants at risk
Participants who took desmopressin melt 10 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
|
Part II: Desmopressin Melt 25 μg
n=135 participants at risk
Participants who took desmopressin melt 25 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
|
Part II: Desmopressin Melt 50 μg
n=132 participants at risk
Participants who took desmopressin melt 50 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
|
Part II: Desmopressin Melt 100 μg
n=127 participants at risk
Participants who took desmopressin melt 100 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
|
Part II: Placebo to Desmopressin Melt 10 μg
n=31 participants at risk
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime
|
Part II: Placebo to Desmopressin Melt 25 μg
n=37 participants at risk
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
|
Part II: Placebo to Desmopressin Melt 50 μg
n=34 participants at risk
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
|
Part II: Placebo to Desmopressin Melt 100 μg
n=34 participants at risk
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.9%
1/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.61%
1/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.9%
1/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.74%
1/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.61%
1/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.9%
1/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.74%
1/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.79%
1/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.74%
1/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.63%
1/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenosquamous cell lung cancer
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.74%
1/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.79%
1/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.63%
1/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.62%
1/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.9%
1/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.63%
1/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
Other adverse events
| Measure |
Part I: Placebo
n=160 participants at risk
Participants took a placebo 'melt' for 28 days to complete Part I of the study.
|
Part I: Desmopressin Melt 10 μg
n=163 participants at risk
Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study.
|
Part I: Desmopressin Melt 25 μg
n=158 participants at risk
Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study.
|
Part I: Desmopressin Melt 50 μg
n=158 participants at risk
Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study.
|
Part I: Desmopressin Melt 100 μg
n=160 participants at risk
Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
|
Part II: Desmopressin Melt 10 μg
n=135 participants at risk
Participants who took desmopressin melt 10 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
|
Part II: Desmopressin Melt 25 μg
n=135 participants at risk
Participants who took desmopressin melt 25 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
|
Part II: Desmopressin Melt 50 μg
n=132 participants at risk
Participants who took desmopressin melt 50 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
|
Part II: Desmopressin Melt 100 μg
n=127 participants at risk
Participants who took desmopressin melt 100 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
|
Part II: Placebo to Desmopressin Melt 10 μg
n=31 participants at risk
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime
|
Part II: Placebo to Desmopressin Melt 25 μg
n=37 participants at risk
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
|
Part II: Placebo to Desmopressin Melt 50 μg
n=34 participants at risk
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
|
Part II: Placebo to Desmopressin Melt 100 μg
n=34 participants at risk
Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
33.1%
53/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
32.5%
53/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
31.6%
50/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
34.2%
54/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
30.6%
49/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
41.5%
56/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
34.8%
47/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
34.8%
46/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
37.0%
47/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
41.9%
13/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
37.8%
14/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
38.2%
13/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
38.2%
13/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Gastrointestinal disorders
Nausea
|
0.62%
1/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.5%
4/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.5%
4/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.7%
9/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
6.2%
10/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.2%
3/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
4.4%
6/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
3.8%
5/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
3.9%
5/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.9%
2/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
3/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
3.1%
5/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
3.8%
6/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.7%
9/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.9%
3/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
4.4%
6/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.2%
7/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
7.6%
10/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
3.1%
4/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.4%
2/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
8.8%
3/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.9%
1/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.5%
2/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.74%
1/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.5%
2/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.4%
3/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
6.5%
2/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.7%
1/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.9%
1/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.5%
2/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
3.7%
5/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.5%
2/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.6%
2/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
6.5%
2/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.7%
1/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.9%
1/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.9%
1/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.5%
2/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.74%
1/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.76%
1/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.6%
2/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.7%
1/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
8.8%
3/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
General disorders
Pain
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.74%
1/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.5%
2/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.3%
3/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.6%
2/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.7%
1/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.9%
2/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.2%
7/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
3.0%
4/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
3.8%
5/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.5%
7/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
3.2%
1/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.4%
2/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.9%
2/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
3.7%
5/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
3.0%
4/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.3%
3/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
3.1%
4/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
3.2%
1/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.4%
2/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.9%
1/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
8.8%
3/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.74%
1/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.3%
3/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.4%
3/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
6.5%
2/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.7%
1/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Investigations
Blood glucose increased
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.5%
2/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.76%
1/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.79%
1/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.7%
1/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.9%
2/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Investigations
Blood sodium decreased
|
0.62%
1/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.2%
2/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.3%
2/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.5%
4/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.6%
9/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
3/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.61%
1/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.63%
1/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.1%
8/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
6.9%
11/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.5%
2/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.5%
2/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.76%
1/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.5%
7/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.7%
1/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.9%
2/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.9%
1/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Nervous system disorders
Headache
|
6.9%
11/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
8.0%
13/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
3.8%
6/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
9.5%
15/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
8.8%
14/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
7.4%
10/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
8.1%
11/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
9.8%
13/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
9.4%
12/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
3.2%
1/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
8.1%
3/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.9%
2/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.9%
2/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Nervous system disorders
Dizziness
|
0.62%
1/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
4.3%
7/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.9%
3/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.1%
8/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
3.8%
6/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Psychiatric disorders
Depression
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.74%
1/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
6.5%
2/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.5%
2/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.76%
1/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.6%
2/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.9%
2/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
|
Vascular disorders
Hypertension
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/163 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/158 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/160 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.5%
2/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.5%
2/135 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
1.5%
2/132 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
2.4%
3/127 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/31 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
5.4%
2/37 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
0.00%
0/34 • Part I covers Day 1 to Week 4. Part II covers Week 5 up to Day169.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention
- Publication restrictions are in place
Restriction type: OTHER