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Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo (NOC)

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ClinicalTrials.gov Identifier: NCT01184859
Recruitment Status : Completed
First Posted : August 19, 2010
Results First Posted : May 25, 2012
Last Update Posted : May 25, 2012
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Nocturia
Interventions Drug: Desmopressin
Drug: Placebo
Enrollment 116
Recruitment Details  
Pre-assignment Details 139 patients randomized and 116 treated. Withdrawals during the screening period were due to urine production did not meet >0.12 mL/kg/min within 2 hours of dosing (22 patients) and violation of inclusion/exclusion criteria (1 patient).
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg
Hide Arm/Group Description Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days. Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days. Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days. Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days. Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Period Title: Period 1: Single Dose
Started 23 25 22 22 24
Full Analysis Set (FAS) 23 23 [1] 22 21 [2] 24
Per Protocol (PP) 23 23 22 21 23 [3]
Completed 23 23 22 22 23
Not Completed 0 2 0 0 1
Reason Not Completed
Insufficient urine production             0             1             0             0             0
Protocol Violation             0             1             0             0             0
Adverse Event             0             0             0             0             1
[1]
2 participants disqualified due to no post-baseline primary efficacy data, and/or 'other'.
[2]
1 participant disqualified due to major entry criteria violation
[3]
1 additional participant disqualified due to 'other'.
Period Title: Washout Period
Started 23 23 22 22 23
Completed 23 23 22 22 23
Not Completed 0 0 0 0 0
Period Title: Period 2: Daily Dose for 28 Days
Started 23 23 22 22 23
Completed 22 23 22 22 22
Not Completed 1 0 0 0 1
Reason Not Completed
Withdrawal by Subject             0             0             0             0             1
Adverse Event             1             0             0             0             0
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg Total
Hide Arm/Group Description Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days. Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days. Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days. Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days. Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days. Total of all reporting groups
Overall Number of Baseline Participants 23 23 22 21 24 113
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 23 participants 22 participants 21 participants 24 participants 113 participants
64.3  (6.4) 67.0  (5.6) 65.5  (6.0) 64.9  (7.1) 65.3  (5.6) 65.4  (6.1)
[1]
Measure Description: FAS population is used for the Baseline Measures
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 22 participants 21 participants 24 participants 113 participants
>=55 and <65 years 12 8 10 10 12 52
>=65 and <76 years 11 15 12 11 12 61
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 22 participants 21 participants 24 participants 113 participants
Female
12
  52.2%
12
  52.2%
11
  50.0%
11
  52.4%
12
  50.0%
58
  51.3%
Male
11
  47.8%
11
  47.8%
11
  50.0%
10
  47.6%
12
  50.0%
55
  48.7%
Number of Nocturnal Voids  
Mean (Standard Deviation)
Unit of measure:  Nocturnal voids
Number Analyzed 23 participants 23 participants 22 participants 21 participants 24 participants 113 participants
2.16  (0.26) 2.43  (0.51) 2.45  (0.45) 2.29  (0.44) 2.26  (0.38) 2.32  (0.42)
Number of Daytime Voids  
Mean (Standard Deviation)
Unit of measure:  Daytime voids
Number Analyzed 23 participants 23 participants 22 participants 21 participants 24 participants 113 participants
7.67  (1.48) 7.97  (1.91) 8.70  (1.53) 8.67  (1.99) 8.33  (1.65) 8.26  (1.74)
Number of 24-hour Voids  
Mean (Standard Deviation)
Unit of measure:  Voids
Number Analyzed 23 participants 23 participants 22 participants 21 participants 24 participants 113 participants
9.83  (1.52) 10.41  (1.94) 11.15  (1.79) 10.95  (2.12) 10.60  (1.60) 10.58  (1.83)
Nocturnal Urine Volume  
Mean (Standard Deviation)
Unit of measure:  mL
Number Analyzed 23 participants 23 participants 22 participants 21 participants 24 participants 113 participants
634.78  (210.54) 568.55  (227.40) 613.06  (182.47) 635.87  (211.53) 631.78  (175.02) 616.64  (200.13)
24-Hour Urine Volume  
Mean (Standard Deviation)
Unit of measure:  mL
Number Analyzed 23 participants 23 participants 22 participants 21 participants 24 participants 113 participants
1742.32  (344.99) 1632.17  (454.75) 1881.67  (399.42) 1848.32  (497.96) 1785.65  (404.67) 1775.93  (423.67)
1.Primary Outcome
Title Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1
Hide Description Participants were water-loaded to suppress the endogenous release of vasopressin, thus all antidiuretic activity was generated by desmopressin only. Water-loading was initiated 2 hours before dosing on Day 1. Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg
Hide Arm/Group Description:
Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Overall Number of Participants Analyzed 23 23 22 21 21
Mean (Standard Deviation)
Unit of Measure: hours
0.00  (0.00) 0.09  (0.32) 2.00  (3.56) 3.45  (2.88) 5.74  (2.99)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Desmopressin 10µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.211
Comments The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Desmopressin 25µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Desmopressin 50µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Desmopressin 100µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2
Hide Description Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average number of nocturnal voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.
Time Frame 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg
Hide Arm/Group Description:
Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Overall Number of Participants Analyzed 22 22 20 19 21
Least Squares Mean (95% Confidence Interval)
Unit of Measure: nocturnal voids
-0.735
(-1.049 to -0.421)
-1.007
(-1.320 to -0.695)
-1.282
(-1.583 to -0.981)
-1.589
(-1.903 to -1.274)
-1.624
(-1.999 to -1.248)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Desmopressin 10µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.194
Comments The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.272
Confidence Interval (2-Sided) 95%
-0.685 to -0.141
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Desmopressin 25µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.547
Confidence Interval (2-Sided) 95%
-0.985 to -0.108
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Desmopressin 50µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.854
Confidence Interval (2-Sided) 95%
-1.317 to -0.391
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Desmopressin 100µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.888
Confidence Interval (2-Sided) 95%
-1.426 to -0.351
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Area Under the Urine Osmolality Curve (AUCosm)
Hide Description Area under the urine osmolality curve, from dose administration to end of action (AUCosm).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg
Hide Arm/Group Description:
Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Overall Number of Participants Analyzed 23 23 22 21 21
Mean (Standard Deviation)
Unit of Measure: h*mOsm/kg
0.00  (0.00) 24.67  (97.50) 852.00  (1576.10) 1551.01  (1501.21) 3112.53  (2131.69)
4.Secondary Outcome
Title Area Under the Urine Production Curve (AUCurine Prod)
Hide Description Area under the urine production curve, from dose administration to end of action (AUCurine prod)
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg
Hide Arm/Group Description:
Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Overall Number of Participants Analyzed 23 23 22 21 23
Mean (Standard Deviation)
Unit of Measure: h*mL
59.34  (153.78) 214.24  (266.86) 297.17  (322.51) 522.99  (283.90) 537.08  (330.67)
5.Secondary Outcome
Title Time When Urine Production <0.12 ml/kg/Min
Hide Description Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration due to water-loading should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg
Hide Arm/Group Description:
Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Overall Number of Participants Analyzed 23 23 22 21 23
Mean (Standard Deviation)
Unit of Measure: hours
0.41  (1.15) 1.67  (2.16) 3.50  (4.17) 6.05  (3.56) 8.20  (2.59)
6.Secondary Outcome
Title Change From Baseline in Duration of First Period of Undisturbed Sleep After 28 Days of Treatment - Period 2
Hide Description

Duration of first period of undisturbed sleep is defined as the length of time from initial sleep to first awakening.

Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average length of first period of undisturbed sleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.

Time Frame 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg
Hide Arm/Group Description:
Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Overall Number of Participants Analyzed 22 22 20 19 21
Mean (Standard Deviation)
Unit of Measure: minutes
68.39  (93.32) 101.85  (120.26) 113.45  (120.22) 190.77  (124.32) 194.25  (99.17)
7.Secondary Outcome
Title Change From Baseline in Total Sleep Time at Approximately Day 32
Hide Description

Total sleep time is defined as the time spent asleep from initial sleep to final awakening.

Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average of the total time asleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.

Time Frame 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg
Hide Arm/Group Description:
Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Overall Number of Participants Analyzed 22 22 20 19 21
Mean (Standard Deviation)
Unit of Measure: minutes
2.47  (49.94) -11.86  (48.57) -33.04  (116.09) 6.81  (69.04) 14.07  (54.06)
8.Secondary Outcome
Title Change From Baseline in Number of Daytime Voids at Approximately Day 32
Hide Description Number of daytime voids was recorded over three consecutive days per week in diaries kept by study participants. The average number of daytime voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Time Frame 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg
Hide Arm/Group Description:
Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Overall Number of Participants Analyzed 22 22 20 19 21
Mean (Standard Deviation)
Unit of Measure: voids
0.49  (1.33) 0.68  (1.53) 0.15  (1.66) 0.23  (1.51) 0.63  (1.74)
9.Secondary Outcome
Title Change From Baseline in Number of 24-hour Urine Voids at Approximately Day 32
Hide Description Number of voids in 24 hours was recorded over three consecutive days per week in diaries kept by study participants. The average number of 24-hour voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Time Frame 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg
Hide Arm/Group Description:
Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Overall Number of Participants Analyzed 22 22 20 19 21
Mean (Standard Deviation)
Unit of Measure: voids
-0.15  (1.71) -0.47  (1.93) -1.19  (1.85) -1.33  (1.81) -0.96  (1.69)
10.Secondary Outcome
Title Change From Baseline in Nocturnal Urine Volume at Approximately Day 32
Hide Description Nocturnal urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Time Frame 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg
Hide Arm/Group Description:
Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Overall Number of Participants Analyzed 22 22 20 19 21
Mean (Standard Deviation)
Unit of Measure: ml
-114.70  (224.53) -140.68  (168.62) -209.87  (262.89) -295.02  (196.71) -333.22  (154.05)
11.Secondary Outcome
Title Change From Baseline in 24-Hour Urine Volume at Approximately Day 32
Hide Description Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average 24-hour urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Time Frame 3 days between study days -6 to 0 (Baseline), and days 25 to 32
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Hide Analysis Population Description
Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg
Hide Arm/Group Description:
Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Overall Number of Participants Analyzed 22 22 20 19 21
Mean (Standard Deviation)
Unit of Measure: ml
-104.47  (386.27) -19.47  (371.72) -201.83  (487.49) -270.53  (344.29) -187.25  (369.61)
12.Secondary Outcome
Title Change From Baseline in 24-Hour Urine Production Per Body Weight at Approximately Day 32
Hide Description Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. Urine volume per body weight was calculated. The average 24-hour urine volume per kg of body weight of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Time Frame 3 days between study days -6 to 0 (Baseline), and days 25 to 32
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Hide Analysis Population Description
Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg
Hide Arm/Group Description:
Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Overall Number of Participants Analyzed 22 22 20 19 21
Mean (Standard Deviation)
Unit of Measure: ml/kg
-2.017  (6.205) -0.096  (6.814) -3.523  (7.621) -4.573  (6.183) -3.058  (6.263)
13.Secondary Outcome
Title Change From Baseline in Nocturnal Polyuria Index at Approximately Day 32
Hide Description Nocturnal polyuria index is defined as a proportion of nocturnal urine volume to the 24-hour urine volume. Urine volume and time of day of those voids was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal polyuria index of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Time Frame 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg
Hide Arm/Group Description:
Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Overall Number of Participants Analyzed 22 22 20 19 21
Mean (Standard Deviation)
Unit of Measure: nocturnal urine volume / 24-hour urine
-4.72  (6.75) -7.82  (6.65) -8.61  (9.28) -13.56  (9.72) -16.00  (6.87)
14.Secondary Outcome
Title Change From Baseline in Nocturia-Related Quality of Life Based on Evaluation Provided by Nocturia Quality of Life Questionnaire (N-QoL) at Approximately Day 32
Hide Description N-QoL assesses the impact of nocturia on quality of life (QoL) and treatment outcomes. N-QoL is a self-administered questionnaire with 13 items using scales of 0 = no negative impact to QoL to the upper number = signficant negative impact to QoL. The sleep/energy domain consists of 7 questions with a scale of 0 to 28. The bother/concern domain consists of 5 questions for a scale of 0 to 20. The 13th question is an overall assessment scored from 0 to 10. The Total Score includes all 13 questions with a scale of 0 (no negative impact to QoL) to 58 (significant negative impact to QoL).
Time Frame Approximately Day 4 (start of period 2) and Day 32
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg
Hide Arm/Group Description:
Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Overall Number of Participants Analyzed 22 23 22 21 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
Sleep/Energy subscale 7.77  (11.66) 10.69  (15.33) 13.26  (15.46) 12.30  (10.82) 8.52  (12.23)
Bother/Concern subscale 6.36  (19.02) 8.99  (16.91) 16.33  (18.35) 10.67  (19.37) 10.15  (14.00)
Total Score 7.04  (14.05) 9.98  (14.65) 14.78  (16.28) 11.44  (13.00) 9.39  (11.11)
15.Secondary Outcome
Title Change From Baseline in Sleep Related Quality of Life Based on the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Approximately Day 32
Hide Description The Global Score of the Pittsburgh Sleep Quality Index (PSQI) is comprised of Questions 2-9 with a total scale of 0 (no difficulty sleeping) to 21 (severe difficulty). The change in Global Score is Global Score at the end of period 2 (day 32) - Global Score at the start of Period 2 (day 4). A negative change indicates an improvement in quality of life.
Time Frame Approximately Day 4 (start of period 2) and Day 32
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg
Hide Arm/Group Description:
Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Overall Number of Participants Analyzed 22 23 21 21 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.2  (2.0) -0.6  (2.3) -1.5  (2.2) -1.4  (2.5) -1.3  (1.8)
16.Secondary Outcome
Title Participant Counts of Minimum Observed Serum Sodium Levels During the Second Treatment Period (Days 4-32)
Hide Description Serum sodium levels were monitored throughout the trial as part of the clinical chemistry panel. If the value was ≤125 mEq/L, the participant was to be withdrawn from the trial and treatment stopped immediately. This outcome reports participants' lowest recorded serum sodium levels during the second treatment period.
Time Frame Days 4- 32
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Hide Analysis Population Description
Safety population which included all randomised and exposed participants. Participants were analysed according to the actual treatment received.
Arm/Group Title Placebo Desmopressin 10µg Desmopressin 25µg Desmopressin 50µg Desmopressin 100µg
Hide Arm/Group Description:
Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
Overall Number of Participants Analyzed 23 23 22 22 23
Measure Type: Number
Unit of Measure: participants
>= 135 mEq/L 23 23 21 21 23
>=130 mEq/L to <135 mEq/L 0 0 1 1 0
<130 mEq/L 0 0 0 0 0
Time Frame Period 1: Day 1 to Day 3 (includes Wash-out period) Period 2: Day 4 (first day of period 2 drug administration) to Day 32 (last day of drug administration or date of withdrawal)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo-Period 1 Desmopressin 10µg - Period 1 Desmopressin 25µg - Period 1 Desmopressin 50µg - Period 1 Desmopressin 100µg - Period 1 Placebo - Period 2 Desmopressin 10µg - Period 2 Desmopressin 25µg - Period 2 Desmopressin 50µg - Period 2 Desmopressin 100µg - Period 2
Hide Arm/Group Description Study period 1: single dose of placebo. Study period 1: single dose of desmopressin 10µg. Study period 1: single dose of desmopressin 25µg. Study period 1: single dose of desmopressin 50µg. Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of placebo taken before bedtime for 28 days. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
All-Cause Mortality
Placebo-Period 1 Desmopressin 10µg - Period 1 Desmopressin 25µg - Period 1 Desmopressin 50µg - Period 1 Desmopressin 100µg - Period 1 Placebo - Period 2 Desmopressin 10µg - Period 2 Desmopressin 25µg - Period 2 Desmopressin 50µg - Period 2 Desmopressin 100µg - Period 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo-Period 1 Desmopressin 10µg - Period 1 Desmopressin 25µg - Period 1 Desmopressin 50µg - Period 1 Desmopressin 100µg - Period 1 Placebo - Period 2 Desmopressin 10µg - Period 2 Desmopressin 25µg - Period 2 Desmopressin 50µg - Period 2 Desmopressin 100µg - Period 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      0/25 (0.00%)      0/22 (0.00%)      0/22 (0.00%)      0/24 (0.00%)      0/23 (0.00%)      0/23 (0.00%)      0/22 (0.00%)      0/22 (0.00%)      0/23 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo-Period 1 Desmopressin 10µg - Period 1 Desmopressin 25µg - Period 1 Desmopressin 50µg - Period 1 Desmopressin 100µg - Period 1 Placebo - Period 2 Desmopressin 10µg - Period 2 Desmopressin 25µg - Period 2 Desmopressin 50µg - Period 2 Desmopressin 100µg - Period 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      1/25 (4.00%)      1/22 (4.55%)      4/22 (18.18%)      7/24 (29.17%)      3/23 (13.04%)      1/23 (4.35%)      4/22 (18.18%)      1/22 (4.55%)      0/23 (0.00%)    
Infections and infestations                     
Nasopharyngitis  1  0/23 (0.00%)  0 0/25 (0.00%)  0 0/22 (0.00%)  0 0/22 (0.00%)  0 0/24 (0.00%)  0 3/23 (13.04%)  4 1/23 (4.35%)  1 2/22 (9.09%)  2 0/22 (0.00%)  0 0/23 (0.00%)  0
Investigations                     
Blood sodium decreased  1  0/23 (0.00%)  0 1/25 (4.00%)  1 0/22 (0.00%)  0 3/22 (13.64%)  3 5/24 (20.83%)  5 0/23 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0 1/22 (4.55%)  1 0/23 (0.00%)  0
Nervous system disorders                     
Headache  1  0/23 (0.00%)  0 0/25 (0.00%)  0 1/22 (4.55%)  1 1/22 (4.55%)  1 2/24 (8.33%)  2 0/23 (0.00%)  0 0/23 (0.00%)  0 2/22 (9.09%)  2 0/22 (0.00%)  0 0/23 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
EMail: DK0-Disclosure@ferring.com
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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01184859    
Other Study ID Numbers: FE992026 CS36
First Submitted: August 18, 2010
First Posted: August 19, 2010
Results First Submitted: April 24, 2012
Results First Posted: May 25, 2012
Last Update Posted: May 25, 2012