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An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00615836
Collaborator
(none)
554
Enrollment
73
Locations
4
Arms
29
Duration (Months)
7.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to investigate the long term efficacy and safety of several doses of the Melt formulation of desmopressin in a broad population of adult patients with nocturia.

Condition or Disease Intervention/Treatment Phase
  • Drug: Desmopressin Melt
 Phase 3

Detailed Description

FE992026 CS31 was a multicenter open-label extension study for patients who were enrolled in Study FE992026 CS29 (NCT00477490) and had completed at least Visit 3E in Part II of that study.

The CS29 study was structured into 2 double-blind parts (Part I and Part II). In Part I, the initial 28-day treatment period, participants were randomly assigned to 1 of 5 treatment groups: placebo or desmopressin Melt 10 μg, 25 μg, 50 μg, or 100 μg. Immediately upon completion of Part I of the study, all participants on active treatment continued into Part II on the same treatment for approximately 1 to 6 months. Participants assigned to placebo in Part I were randomly assigned to 1 of the 4 active treatments in Part II, based on re-randomization predetermined at the initial randomization (to maintain the blind). Part II began at the final visit for Part I and continued until the database for Part I was locked. Therefore, treatment duration for Part II varied between 1 and 6 months, depending upon when the participant entered.

Upon completion of Part II of CS29, participants were given the option to participate in the open-label extension study (CS31). During CS31, each participant assigned to the 10 μg dose was switched to a higher dose in an open-label manner among the remaining 3 higher doses.

Study Design

Study Type:
Interventional
Actual Enrollment :
554 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-Center Extension Study Investigating the Long Term Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults
Study Start Date :
Dec 1, 2007
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Desmopressin Melt 10 μg

Participants received desmopressin melt 10 μg once a day, placed under the tongue one hour before bedtime until they were re-randomized to one of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).

Drug: Desmopressin Melt
An orally disintegrating tablet of desmopressin administered under the tongue (sublingually), without water.
Other Names:
  • Minirin® Melt
  • Nocturin®
  • FE992026

    		•
    Experimental: Desmopressin Melt 25 μg

    Participants received desmopressin melt 25 μg once a day, placed under the tongue one hour before bedtime for up to 2 years and 2.5 months.

    Drug: Desmopressin Melt
    An orally disintegrating tablet of desmopressin administered under the tongue (sublingually), without water.
    Other Names:
  • Minirin® Melt
  • Nocturin®
  • FE992026

    		•
    Experimental: Desmopressin Melt 50 μg

    Participants received desmopressin melt 50 μg once a day, placed under the tongue one hour before bedtime for up to 2 years and 2.5 months.

    Drug: Desmopressin Melt
    An orally disintegrating tablet of desmopressin administered under the tongue (sublingually), without water.
    Other Names:
  • Minirin® Melt
  • Nocturin®
  • FE992026

    		•
    Experimental: Desmopressin Melt 100 μg

    Participants received desmopressin melt 100 μg once a day, placed under the tongue one hour before bedtime for up to 2 years and 2.5 months.

    Drug: Desmopressin Melt
    An orally disintegrating tablet of desmopressin administered under the tongue (sublingually), without water.
    Other Names:
  • Minirin® Melt
  • Nocturin®
  • FE992026

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Mean Number of Nocturnal Voids [Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.]

      Participants completed a voiding diary for 3 consecutive 24-hour periods prior to the study visit in which they recorded each nocturnal urination (void). The mean number of voids per night was the average number of voids from the 3-day diary. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug. Participants in the 10μg arm are included only until the time of dose escalation.

    2. Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids [Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.]

      Percentage of participants with >33% reduction from Baseline in the mean number of nocturnal urinations per night, calculated from the 3-day voiding diary completed prior to each study visit. Participants in the 10μg arm are included only until the time of dose escalation.

    3. Change From Baseline in Initial Period of Undisturbed Sleep [Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.]

      Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the initial period of undisturbed sleep was calculated and averaged for the 3 days. The Initial Period of Undisturbed Sleep is the time elapsed from bedtime to either first void or morning arising minus the minutes it took to fall asleep. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug. Participants in the 10μg arm are included only until the time of dose escalation.

    Secondary Outcome Measures

    1. Change From Baseline in Total Sleep Time [Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.]

      Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the total sleep time was calculated and averaged for the 3 days. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug. Participants in the 10μg arm are included only until the time of dose escalation.

    2. Change From Baseline in International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) Nighttime Urination Bother Score [Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)]

      The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. To assess nighttime urination bother, participants were asked to rate the degree of bother of nighttime urination by answering the question "Night time urination: How much does this bother you?" on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate greater bother. Participants in the 10μg arm are included only until the time of dose escalation.

    3. Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score [Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)]

      The NQoL is a self-administered 13-item 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 (which is not included in the overall score). The 12 core items are scored on a 0 to 4 scale, and the overall score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating better impact on quality of life. Participants in the 10μg arm are included only until the time of dose escalation.

    4. Change From Baseline in NQoL Bother/Concern Domain Score [Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)]

      The NQoL is a self-administered 13-item 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 12 core items are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. The bother/concern domain summary score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better impact on quality of life. Participants in the 10μg arm are included only until the time of dose escalation.

    5. Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score [Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)]

      The NQoL is a self-administered 13-item 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 12 core items are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. The sleep/energy domain summary score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better impact on quality of life. Participants in the 10μg arm are included only until the time of dose escalation.

    6. Change From Baseline in the Nocturia Quality of Life (NQoL) Global Quality of Life Score [Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)]

      The NQoL is a self-administered 13-item 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 global QoL question is scored on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate better impact on quality of life. Participants in the 10μg arm are included only until the time of dose escalation.

    7. Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score [Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)]

      The PSQI is a self-administered 19-item questionnaire designed to assess sleep quality and disturbances. The 19 individual items are scored on an evenly weighted 0 to 3 scale and generate 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score ranging from 0 to 21. Higher numbers indicate greater sleep disturbance. Participants in the 10μg arm are included only until the time of dose escalation.

    8. Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Mental Component Summary Score [Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)]

      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 spanning 8 domains: physical functioning, role function-physical, role function-emotional, bodily pain, general health, vitality, social functioning, and mental health. These scales are combined to create 2 summary measures: the Physical Health Summary and Mental Health Summary. The Mental Health Summary score ranges from 0 to 100, where higher numbers indicate better quality of life. Participants in the 10μg arm are included only until the time of dose escalation.

    9. Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Physical Component Summary Score [Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)]

      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 spanning 8 domains: physical functioning, role function-physical, role function-emotional, bodily pain, general health, vitality, social functioning, and mental health. These scales are combined to create 2 summary measures: the Physical Health Summary and Mental Health Summary. The Physical Health Summary score ranges from 0 to 100, where higher numbers indicate better quality of life. Participants in the 10μg arm are included only until the time of dose escalation.

    10. Participants With Treatment-Emergent Adverse Events (AEs) [From first dose of study drug in Study CS29 until the end of study CS31 (up to 35 months).]

      An AE was any untoward medical occurrence that did not necessarily have a causal relationship with the study drug. An adverse drug reaction (ADR) was an AE evaluated by the Investigator as being probably or possibly causally related to treatment with the study drug. A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event that could have jeopardized the patient's safety or required medical or surgical intervention to prevent 1 of the outcomes listed above. The intensity of an AE was defined as severe if it resulted in the inability to work or perform usual activities.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Written informed consent prior to the performance of any study-related activity.

    • Was randomized into Part II of Protocol FE992026 CS29 (NCT00477490), entitled "A Randomized, Double Blind,Placebo Controlled, Parallel Group, Multi-Center Study with a Double Blind Extension Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults" and have completed at least Visit 3E in Part II (Day 15).

    Exclusion Criteria:
    • Patients using loop diuretics (furosemide, torsemide, ethacrynic acid).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Radiant Research Scottsdale Arizona United States 85251
    2 Arkansas Primary Care Clinic, PA Little Rock Arkansas United States 72204
    3 Advanced Urology Medical Center Anaheim California United States 92801
    4 Impact Clinical Trials Beverly Hills California United States 90211
    5 California Professional Research Newport Beach California United States 92660
    6 San Diego Uro-Reseach San Diego California United States 92103
    7 Radiant Research Santa Rosa California United States 95405
    8 West Coast Clinical Research Tarzana California United States 91356
    9 Western Clinical Research Torrance California United States 90505
    10 Urology Associates PC Denver Colorado United States 80210
    11 Downtown Women's Health Care Denver Colorado United States 80218
    12 Genitourinary Surgical Consultants Denver Colorado United States 80220
    13 Connecticut Clinical Research Center, LLC Middlebury Connecticut United States 06762
    14 South Florida Medical Research Aventura Florida United States 33180
    15 Women's Health Research Group, LLC Clearwater Florida United States 33759
    16 Radiant Research - St. Petersburg Pinellas Park Florida United States 33781
    17 Sunrise Medical Research Plantation Florida United States 33324
    18 Radiant Research Stuart Florida United States 34996
    19 Tampa Bay Urology Tampa Florida United States 33607
    20 Radiant Research West Palm Beach Florida United States 33407
    21 Southeastern Medical Research Institute Columbus Georgia United States 31904
    22 Investigational site Dunwoody Georgia United States 30338
    23 Radiant Research, Inc Chicago Illinois United States 60654
    24 Accelovance Peoria Illinois United States 61602
    25 Radiant Research, Kansas City Overland Park Kansas United States 66202
    26 Benchmark Research Metairie Louisiana United States 70006
    27 Regional Urology, LLC Shreveport Louisiana United States 71106
    28 FutureCare Studies, Inc. Springfield Massachusetts United States 01103
    29 Radiant Research, Minneapolis Edina Minnesota United States 55435
    30 Radiant Research, Inc. St. Louis Missouri United States 63141
    31 Women's Clinic of Lincoln, P.C. Lincoln Nebraska United States 68510
    32 Sheldon J Freedman Ltd Las Vegas Nevada United States
    33 Central Jersey Medical Research Center Elizabeth New Jersey United States 07202
    34 Lawrenceville Urology, P.A. DBA Lawrenceville New Jersey United States 08648
    35 Urology Group of New Mexico, PC Albuquerque New Mexico United States 87109
    36 Investigational site - Adult & Pediatric Urology Carmel New York United States 10512
    37 AccuMed Research Associates Garden City New York United States 11530
    38 University Urology Associates New York New York United States 10016
    39 Upstate Urology NY New York United States 12206-1092
    40 Hudson Valley Urology, PC Poughkeepsie New York United States 12601
    41 PharmQuest Greensboro North Carolina United States 27408
    42 New Hanover Medical Research Wilmington North Carolina United States 28401
    43 Piedmont Medical Research Associates Winston-Salem North Carolina United States 27103
    44 Radiant Research Inc. Cincinnati Ohio United States 45249
    45 Radiant Research - Akron Mogadore Ohio United States 44260
    46 Urologic Consultants of SE PA Bala Cynwyd Pennsylvania United States 19004
    47 Philadelphia Clinical Research, LLC Philadelphia Pennsylvania United States 19114
    48 Advanced Clinical Concepts West Readings Pennsylvania United States 19611
    49 Radiant Research, Greer Greer South Carolina United States 29651
    50 Palmetto Medical Research Mt. Pleasant South Carolina United States 29464
    51 Carolina Urologic Research Center Myrtle Beach South Carolina United States 29572
    52 Holston Medical Group Kingsport Tennessee United States 37660
    53 Advanced Research Associates Corpus Christi Texas United States 78414
    54 Investigational site - NationsMed Clinical Research Houston Texas United States 77004
    55 Accelovance Houston Texas United States 77024
    56 Regional Medical Center and Diagnostic Humble Texas United States 77338
    57 Innovative Clinical Trials San Antonio Texas United States 78229
    58 Radiant Research San Antonio San Antonio Texas United States 78229
    59 IMED Research, P.A. San Antonio Texas United States 78258
    60 NationsMed Stafford Texas United States
    61 Virginia Urology Richmond Virginia United States 23235
    62 Urology of Virginia PC Virginia Beach Virginia United States 23454
    63 Women's Clinical Research Center Seattle Washington United States 98105
    64 Seattle Urology Research Center Seattle Washington United States 98166
    65 Southern Interior Medical Research Inc. Kelowna British Columbia Canada V1Y-2H4
    66 Can-Med Clinical Research Inc. Victoria British Columbia Canada V8T 5G1
    67 Investigational site - Clinical Research Victoria British Columbia Canada V8V 3N1
    68 Investigational site - Professional Corporation Fredericton New Brunswick Canada E3B 5B8
    69 The Male/Female Health and Research Barrie Ontario Canada L4M 7G1
    70 Brantford Urology Research Brantford Ontario Canada N3R 4N3
    71 Guelph Urology Associates Guelph Ontario Canada N1H 5J1
    72 Investigational site North Bay Ontario Canada P1B 7K8
    73 The Fe/Male Health Centres Oakville Ontario Canada L6H 3P1

    Sponsors and Collaborators

    • Ferring Pharmaceuticals

    Investigators

    • Study Director: Clinical Development Support, Ferring Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ferring Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00615836
    Other Study ID Numbers:
    • FE992026 CS31
    First Posted:
    Feb 14, 2008
    Last Update Posted:
    Dec 15, 2015
    Last Verified:
    Nov 1, 2015
    Additional relevant MeSH terms:
    Nocturia
    Deamino Arginine Vasopressin

    Study Results

    Participant Flow

    Recruitment Details The study was open only to participants who were enrolled in Study FE992026 CS29 (NCT00477490) and had completed at least Visit 3E in Part II (Day 15) of that study. 799 patients were randomized to treatment in CS29, and 601 patients formed the intent-to-treat population in CS29. This population was used to assess durability of effect in CS31.
    Pre-assignment Detail Participants were initially assigned in a blinded manner to the same treatment dose received in Study CS29. After CS29 database lock, CS31 was unblinded, and based on the results of CS29, participants assigned to 10 μg were randomly assigned at their next scheduled visit to 25 μg, 50 μg, or 100 μg of desmopressin Melt.
    Arm/Group Title Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg Placebo
    Arm/Group Description Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29, continuing in Study CS31. During CS31, based on the results of CS29, participants were randomly assigned to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg). Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31. Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31. Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31. Participants took a placebo 'Melt' for 28 days to complete Part I of Study CS29. In Part II, placebo patients were randomized to 1 of the other 4 treatment arms to receive active desmopressin Melt, continuing into Study CS31.
    Period Title: Part I of Core Study (FE992026 CS29)
    STARTED 163 158 158 160 160
    Intent-to-treat Population 155 152 148 146 156
    COMPLETED 144 148 138 135 145
    NOT COMPLETED 19 10 20 25 15
    Period Title: Part I of Core Study (FE992026 CS29)
    STARTED 141 144 132 137 0
    COMPLETED 0 58 59 53 0
    NOT COMPLETED 141 86 73 84 0

    Baseline Characteristics

    Arm/Group Title Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg Total
    Arm/Group Description Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg). Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Total of all reporting groups
    Overall Participants 155 152 148 146 601
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    61.7
    (14.41)
    62.4
    (13.22)
    61.6
    (11.80)
    62.1
    (12.34)
    61.9
    (12.97)
    Age, Customized (participants) [Number]
    <65 years
    80
    51.6%
    65
    42.8%
    71
    48%
    66
    45.2%
    282
    46.9%
    >=65 years
    75
    48.4%
    87
    57.2%
    77
    52%
    80
    54.8%
    319
    53.1%
    Sex: Female, Male (Count of Participants)
    Female
    73
    47.1%
    65
    42.8%
    71
    48%
    66
    45.2%
    275
    45.8%
    Male
    82
    52.9%
    87
    57.2%
    77
    52%
    80
    54.8%
    326
    54.2%
    Race/Ethnicity, Customized (participants) [Number]
    Caucasian
    123
    79.4%
    120
    78.9%
    119
    80.4%
    111
    76%
    473
    78.7%
    Black/African American
    21
    13.5%
    28
    18.4%
    24
    16.2%
    27
    18.5%
    100
    16.6%
    Asian
    2
    1.3%
    2
    1.3%
    3
    2%
    6
    4.1%
    13
    2.2%
    American Indian/Alaskan Native
    2
    1.3%
    0
    0%
    0
    0%
    0
    0%
    2
    0.3%
    Native Hawaiian/other Pacific Islander
    1
    0.6%
    1
    0.7%
    0
    0%
    0
    0%
    2
    0.3%
    Other
    6
    3.9%
    1
    0.7%
    2
    1.4%
    2
    1.4%
    11
    1.8%
    Ethnic Origin (participants) [Number]
    Hispanic
    10
    6.5%
    10
    6.6%
    13
    8.8%
    6
    4.1%
    39
    6.5%
    Not Hispanic
    145
    93.5%
    142
    93.4%
    135
    91.2%
    140
    95.9%
    562
    93.5%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Mean Number of Nocturnal Voids
    Description Participants completed a voiding diary for 3 consecutive 24-hour periods prior to the study visit in which they recorded each nocturnal urination (void). The mean number of voids per night was the average number of voids from the 3-day diary. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug. Participants in the 10μg arm are included only until the time of dose escalation.
    Time Frame Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.

    Outcome Measure Data

    Analysis Population Description
    Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
    Arm/Group Title Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg
    Arm/Group Description Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg). Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
    Measure Participants 155 152 148 146
    8 Weeks [N=103, 96, 92, 104]
    -1.12
    (1.166)
    -1.30
    (1.180)
    -1.42
    (1.278)
    -1.47
    (1.080)
    12 Weeks [N=85, 81, 77, 81]
    -1.15
    (1.151)
    -1.40
    (1.249)
    -1.48
    (1.155)
    -1.73
    (1.040)
    20 Weeks [N=62, 58, 64, 64]
    -1.25
    (1.167)
    -1.61
    (1.175)
    -1.69
    (1.167)
    -1.86
    (1.082)
    28 Weeks [N=63, 85, 62, 62]
    -1.47
    (1.389)
    -1.36
    (1.141)
    -1.49
    (1.276)
    -1.81
    (0.903)
    52-56 Weeks [N=45, 91, 81, 77]
    -1.79
    (1.291)
    -1.40
    (1.224)
    -1.78
    (1.342)
    -2.14
    (1.109)
    72-76 Weeks [N=0, 79, 72, 67]
    NA
    (NA)
    -1.51
    (1.253)
    -1.86
    (1.345)
    -2.24
    (1.287)
    92-96 Weeks [N=0, 68, 62, 62]
    NA
    (NA)
    -1.39
    (1.180)
    -1.91
    (1.359)
    -2.09
    (1.219)
    2. Primary Outcome
    Title Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids
    Description Percentage of participants with >33% reduction from Baseline in the mean number of nocturnal urinations per night, calculated from the 3-day voiding diary completed prior to each study visit. Participants in the 10μg arm are included only until the time of dose escalation.
    Time Frame Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.

    Outcome Measure Data

    Analysis Population Description
    Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
    Arm/Group Title Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg
    Arm/Group Description Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg). Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
    Measure Participants 155 152 148 146
    8 Weeks [N=103, 96, 92, 104]
    57.3
    37%
    63.5
    41.8%
    67.4
    45.5%
    68.3
    46.8%
    12 Weeks [N=85, 81, 77, 81]
    60.0
    38.7%
    67.9
    44.7%
    70.1
    47.4%
    81.5
    55.8%
    20 Weeks [N=62, 58, 64, 64]
    56.5
    36.5%
    79.3
    52.2%
    76.6
    51.8%
    82.8
    56.7%
    28 Weeks [N=63, 85, 62, 62]
    63.5
    41%
    65.9
    43.4%
    74.2
    50.1%
    87.1
    59.7%
    52-56 Weeks [N=45, 91, 81, 77]
    75.6
    48.8%
    73.6
    48.4%
    71.6
    48.4%
    88.3
    60.5%
    72-76 Weeks [N=0, 79, 72, 67]
    NA
    NaN
    69.6
    45.8%
    77.8
    52.6%
    86.6
    59.3%
    92-96 Weeks [N=0, 68, 62, 62]
    NA
    NaN
    63.2
    41.6%
    77.4
    52.3%
    88.7
    60.8%
    3. Primary Outcome
    Title Change From Baseline in Initial Period of Undisturbed Sleep
    Description Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the initial period of undisturbed sleep was calculated and averaged for the 3 days. The Initial Period of Undisturbed Sleep is the time elapsed from bedtime to either first void or morning arising minus the minutes it took to fall asleep. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug. Participants in the 10μg arm are included only until the time of dose escalation.
    Time Frame Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.

    Outcome Measure Data

    Analysis Population Description
    Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
    Arm/Group Title Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg
    Arm/Group Description Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg). Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
    Measure Participants 155 152 148 146
    8 Weeks [N=93, 82, 83, 90]
    77.64
    (118.822)
    96.58
    (112.750)
    104.72
    (120.236)
    126.63
    (114.501)
    12 Weeks [N=78, 69, 66, 72]
    97.57
    (116.855)
    116.70
    (110.738)
    118.71
    (112.450)
    144.77
    (116.376)
    20 Weeks [N=55, 51, 59, 58]
    94.51
    (113.892)
    115.60
    (105.136)
    133.66
    (151.510)
    155.44
    (119.185)
    28 Weeks [N=59, 80, 58, 61]
    113.60
    (122.291)
    116.46
    (114.475)
    101.04
    (121.681)
    143.86
    (114.170)
    52-56 Weeks [N=42, 88, 75, 71]
    120.91
    (134.943)
    110.59
    (113.658)
    121.34
    (129.149)
    167.72
    (118.301)
    72-76 Weeks [N=0, 77, 68, 60]
    NA
    (NA)
    125.21
    (134.963)
    137.91
    (136.870)
    200.67
    (137.206)
    92-96 Weeks [N=0, 66, 56, 57]
    NA
    (NA)
    134.14
    (172.834)
    163.31
    (124.169)
    185.74
    (118.865)
    4. Secondary Outcome
    Title Change From Baseline in Total Sleep Time
    Description Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the total sleep time was calculated and averaged for the 3 days. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug. Participants in the 10μg arm are included only until the time of dose escalation.
    Time Frame Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.

    Outcome Measure Data

    Analysis Population Description
    Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
    Arm/Group Title Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg
    Arm/Group Description Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg). Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
    Measure Participants 155 152 148 146
    8 Weeks [N=103, 96, 91, 104]
    13.93
    (65.628)
    19.77
    (71.609)
    33.17
    (77.892)
    14.68
    (76.679)
    12 Weeks [N=85, 81, 77, 81]
    20.66
    (65.419)
    24.94
    (65.785)
    30.34
    (68.221)
    12.90
    (73.777)
    20 Weeks [N=61, 58, 64, 64]
    12.64
    (63.952)
    36.13
    (67.708)
    34.01
    (93.074)
    24.54
    (75.385)
    28 Weeks [N=64, 85, 62, 62]
    11.12
    (62.382)
    34.99
    (65.342)
    33.99
    (74.539)
    22.25
    (69.033)
    52-56 Weeks [N=46, 91, 80, 77]
    21.09
    (65.705)
    20.86
    (71.695)
    25.68
    (95.625)
    15.84
    (77.880)
    72-76 Weeks [N=0, 80, 72, 66]
    NA
    (NA)
    26.44
    (70.467)
    33.22
    (78.286)
    19.34
    (92.171)
    92-96 Weeks [N=0, 67, 61, 62]
    NA
    (NA)
    23.45
    (65.624)
    37.33
    (82.320)
    26.83
    (95.183)
    5. Secondary Outcome
    Title Change From Baseline in International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) Nighttime Urination Bother Score
    Description The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. To assess nighttime urination bother, participants were asked to rate the degree of bother of nighttime urination by answering the question "Night time urination: How much does this bother you?" on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate greater bother. Participants in the 10μg arm are included only until the time of dose escalation.
    Time Frame Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

    Outcome Measure Data

    Analysis Population Description
    Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
    Arm/Group Title Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg
    Arm/Group Description Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg). Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
    Measure Participants 155 152 148 146
    Week 16 [N=34, 42, 44, 35]
    -3.68
    (3.409)
    -2.62
    (3.695)
    -3.77
    (3.436)
    -3.71
    (3.295)
    Visit 12 [N=0, 84, 77, 67]
    NA
    (NA)
    -2.83
    (3.488)
    -3.77
    (3.211)
    -4.12
    (3.240)
    End of Study [N=17, 93, 84, 82]
    -3.12
    (2.934)
    -2.96
    (3.668)
    -3.46
    (3.504)
    -3.62
    (3.512)
    6. Secondary Outcome
    Title Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score
    Description The NQoL is a self-administered 13-item 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 (which is not included in the overall score). The 12 core items are scored on a 0 to 4 scale, and the overall score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating better impact on quality of life. Participants in the 10μg arm are included only until the time of dose escalation.
    Time Frame Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

    Outcome Measure Data

    Analysis Population Description
    Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
    Arm/Group Title Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg
    Arm/Group Description Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg). Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
    Measure Participants 155 152 148 146
    Week 16 [N=34, 42, 44, 35]
    20.16
    (29.515)
    22.42
    (18.752)
    22.06
    (21.985)
    26.13
    (22.728)
    Visit 12 [N=0, 84, 77, 66]
    NA
    (NA)
    19.37
    (19.362)
    21.51
    (22.838)
    19.89
    (19.684)
    End of Study [N=17, 94, 85, 80]
    12.87
    (16.913)
    17.46
    (20.497)
    19.13
    (23.393)
    18.36
    (19.684)
    7. Secondary Outcome
    Title Change From Baseline in NQoL Bother/Concern Domain Score
    Description The NQoL is a self-administered 13-item 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 12 core items are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. The bother/concern domain summary score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better impact on quality of life. Participants in the 10μg arm are included only until the time of dose escalation.
    Time Frame Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

    Outcome Measure Data

    Analysis Population Description
    Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
    Arm/Group Title Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg
    Arm/Group Description Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg). Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
    Measure Participants 155 152 148 146
    Week 16 [N=34, 42, 44, 35]
    22.43
    (28.977)
    22.82
    (20.083)
    23.30
    (26.783)
    28.81
    (27.010)
    Visit 12 [N=0, 83, 77, 66]
    NA
    (NA)
    18.27
    (21.979)
    19.70
    (23.702)
    17.11
    (21.658)
    End of Study [N=17, 94, 84, 80]
    13.73
    (23.047)
    14.23
    (20.589)
    16.47
    (25.871)
    16.25
    (21.335)
    8. Secondary Outcome
    Title Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score
    Description The NQoL is a self-administered 13-item 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 12 core items are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. The sleep/energy domain summary score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better impact on quality of life. Participants in the 10μg arm are included only until the time of dose escalation.
    Time Frame Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

    Outcome Measure Data

    Analysis Population Description
    Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
    Arm/Group Title Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg
    Arm/Group Description Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg). Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
    Measure Participants 155 152 148 146
    Week 16 [N=34, 42, 44, 35]
    17.89
    (34.152)
    22.02
    (20.645)
    20.83
    (20.333)
    23.45
    (21.534)
    Visit 12 [N=0, 85, 77, 66]
    NA
    (NA)
    20.20
    (21.046)
    23.32
    (25.311)
    22.66
    (20.829)
    End of Study [N=17, 93, 84, 81]
    12.01
    (18.510)
    20.30
    (25.070)
    21.83
    (23.884)
    20.58
    (22.208)
    9. Secondary Outcome
    Title Change From Baseline in the Nocturia Quality of Life (NQoL) Global Quality of Life Score
    Description The NQoL is a self-administered 13-item 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 global QoL question is scored on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate better impact on quality of life. Participants in the 10μg arm are included only until the time of dose escalation.
    Time Frame Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

    Outcome Measure Data

    Analysis Population Description
    Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
    Arm/Group Title Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg
    Arm/Group Description Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg). Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
    Measure Participants 155 152 148 146
    Week 16 [N=34, 42, 44, 35]
    0.29
    (0.799)
    0.36
    (0.932)
    0.68
    (0.708)
    0.26
    (0.701)
    Visit 12 [N=0, 85, 77, 69]
    NA
    (NA)
    0.38
    (1.112)
    0.48
    (0.788)
    0.46
    (0.867)
    End of Study [N=17, 93, 85, 81]
    0.18
    (0.529)
    0.34
    (0.801)
    0.47
    (0.933)
    0.43
    (0.851)
    10. Secondary Outcome
    Title Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score
    Description The PSQI is a self-administered 19-item questionnaire designed to assess sleep quality and disturbances. The 19 individual items are scored on an evenly weighted 0 to 3 scale and generate 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score ranging from 0 to 21. Higher numbers indicate greater sleep disturbance. Participants in the 10μg arm are included only until the time of dose escalation.
    Time Frame Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

    Outcome Measure Data

    Analysis Population Description
    Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
    Arm/Group Title Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg
    Arm/Group Description Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg). Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
    Measure Participants 155 152 148 146
    Week 16 [N=32, 39, 42, 34]
    -2.41
    (3.555)
    -2.59
    (3.507)
    -3.52
    (3.556)
    -2.94
    (3.084)
    Visit 12 [N=0, 80, 73, 65]
    NA
    (NA)
    -1.59
    (3.546)
    -2.99
    (3.747)
    -2.66
    (3.374)
    End of Study [N=16, 89, 78, 78]
    -1.69
    (2.387)
    -2.12
    (3.680)
    -2.88
    (4.212)
    -1.54
    (3.617)
    11. Secondary Outcome
    Title Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Mental Component Summary Score
    Description 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 spanning 8 domains: physical functioning, role function-physical, role function-emotional, bodily pain, general health, vitality, social functioning, and mental health. These scales are combined to create 2 summary measures: the Physical Health Summary and Mental Health Summary. The Mental Health Summary score ranges from 0 to 100, where higher numbers indicate better quality of life. Participants in the 10μg arm are included only until the time of dose escalation.
    Time Frame Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

    Outcome Measure Data

    Analysis Population Description
    Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
    Arm/Group Title Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg
    Arm/Group Description Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg). Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
    Measure Participants 155 152 148 146
    Week 16 [N=34, 42, 44, 34]
    5.82
    (7.784)
    3.84
    (9.101)
    1.57
    (8.910)
    4.14
    (8.590)
    Visit 12 [N=0, 82, 73, 66]
    NA
    (NA)
    0.53
    (8.167)
    1.39
    (11.163)
    0.14
    (8.858)
    End of Study [N=17, 91, 81, 80]
    -0.49
    (8.426)
    3.15
    (9.929)
    1.77
    (12.017)
    1.30
    (9.954)
    12. Secondary Outcome
    Title Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Physical Component Summary Score
    Description 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 spanning 8 domains: physical functioning, role function-physical, role function-emotional, bodily pain, general health, vitality, social functioning, and mental health. These scales are combined to create 2 summary measures: the Physical Health Summary and Mental Health Summary. The Physical Health Summary score ranges from 0 to 100, where higher numbers indicate better quality of life. Participants in the 10μg arm are included only until the time of dose escalation.
    Time Frame Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

    Outcome Measure Data

    Analysis Population Description
    Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
    Arm/Group Title Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg
    Arm/Group Description Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg). Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months. Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
    Measure Participants 155 152 148 146
    Week 16 [N=34, 42, 44, 34]
    1.23
    (7.387)
    1.42
    (7.444)
    2.62
    (6.934)
    0.14
    (8.900)
    Visit 12 [N=0, 82, 73, 66]
    NA
    (NA)
    1.35
    (8.170)
    2.08
    (8.879)
    2.28
    (7.222)
    End of Study [N=17, 91, 81, 80]
    1.29
    (4.077)
    -0.02
    (7.274)
    1.75
    (8.794)
    -0.67
    (9.923)
    13. Secondary Outcome
    Title Participants With Treatment-Emergent Adverse Events (AEs)
    Description An AE was any untoward medical occurrence that did not necessarily have a causal relationship with the study drug. An adverse drug reaction (ADR) was an AE evaluated by the Investigator as being probably or possibly causally related to treatment with the study drug. A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event that could have jeopardized the patient's safety or required medical or surgical intervention to prevent 1 of the outcomes listed above. The intensity of an AE was defined as severe if it resulted in the inability to work or perform usual activities.
    Time Frame From first dose of study drug in Study CS29 until the end of study CS31 (up to 35 months).

    Outcome Measure Data

    Analysis Population Description
    Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure; therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
    Arm/Group Title Placebo Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg
    Arm/Group Description Participants took a placebo 'Melt' for 28 days to complete Part I of study CS29. In Part II, placebo patients were randomized to 1 of the other 4 treatment arms to receive active desmopressin Melt. Participants received desmopressin Melt 10 μg once a day, in CS29 and CS31 until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg). Participants received desmopressin Melt 25 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31. Participants received desmopressin Melt 50 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31. Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
    Measure Participants 160 195 227 217 224
    All adverse events
    81
    52.3%
    149
    98%
    188
    127%
    187
    128.1%
    190
    31.6%
    Deaths
    0
    0%
    0
    0%
    2
    1.4%
    2
    1.4%
    0
    0%
    Serious adverse events
    1
    0.6%
    9
    5.9%
    22
    14.9%
    29
    19.9%
    21
    3.5%
    AEs leading to discontinuation
    7
    4.5%
    14
    9.2%
    20
    13.5%
    33
    22.6%
    31
    5.2%
    Severe adverse events
    2
    1.3%
    21
    13.8%
    36
    24.3%
    39
    26.7%
    25
    4.2%
    Adverse drug reactions (ADRs)
    52
    33.5%
    88
    57.9%
    87
    58.8%
    100
    68.5%
    107
    17.8%

    Adverse Events

    Time Frame From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
    Adverse Event Reporting Description Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
    Arm/Group Title Placebo Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg
    Arm/Group Description Participants took a placebo 'melt' for 28 days to complete Part I of study CS29. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt. Participants received desmopressin melt 10 μg once a day, in CS29 and CS31 until they were re-randomized to one of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg). Participants received desmopressin melt 25 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31. Participants received desmopressin melt 50 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31. Participants received desmopressin melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
    All Cause Mortality
    Placebo Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Placebo Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/160 (0.6%) 9/195 (4.6%) 22/227 (9.7%) 29/217 (13.4%) 21/224 (9.4%)
    Blood and lymphatic system disorders
    Leukocytosis 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Thrombocythaemia 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Cardiac disorders
    Atrial Fibrillation 0/160 (0%) 1/195 (0.5%) 1/227 (0.4%) 4/217 (1.8%) 1/224 (0.4%)
    Cardiac Failure Congestive 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 1/224 (0.4%)
    Extrasystoles 0/160 (0%) 0/195 (0%) 0/227 (0%) 0/217 (0%) 1/224 (0.4%)
    Myocardial Infarction 0/160 (0%) 1/195 (0.5%) 1/227 (0.4%) 0/217 (0%) 1/224 (0.4%)
    Left Ventricular Hypertrophy 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Sick Sinus Syndrome 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Congenital, familial and genetic disorders
    Spondylolisthesis 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Ear and labyrinth disorders
    Vertigo 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Gastrointestinal disorders
    Diverticulum 0/160 (0%) 0/195 (0%) 0/227 (0%) 0/217 (0%) 1/224 (0.4%)
    Abdominal Adhesions 0/160 (0%) 1/195 (0.5%) 0/227 (0%) 0/217 (0%) 0/224 (0%)
    Duodenal Ulcer Haemorrhage 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Haemorrhoids 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Intestinal Obstruction 0/160 (0%) 1/195 (0.5%) 0/227 (0%) 0/217 (0%) 0/224 (0%)
    Pancreatitis 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Small Intestinal Obstruction 0/160 (0%) 0/195 (0%) 0/227 (0%) 2/217 (0.9%) 0/224 (0%)
    General disorders
    Non-Cardiac Chest Pain 0/160 (0%) 0/195 (0%) 0/227 (0%) 0/217 (0%) 2/224 (0.9%)
    Asthenia 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Hepatobiliary disorders
    Cholelithiasis 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Infections and infestations
    Cellulitis 0/160 (0%) 0/195 (0%) 0/227 (0%) 0/217 (0%) 1/224 (0.4%)
    Lung Infection 0/160 (0%) 1/195 (0.5%) 0/227 (0%) 0/217 (0%) 1/224 (0.4%)
    Upper Respiratory Tract Infection 0/160 (0%) 0/195 (0%) 0/227 (0%) 0/217 (0%) 1/224 (0.4%)
    Appendicitis 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Diverticulitis 0/160 (0%) 1/195 (0.5%) 0/227 (0%) 0/217 (0%) 0/224 (0%)
    Hepatitis B 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Pneumonia 0/160 (0%) 1/195 (0.5%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Injury, poisoning and procedural complications
    Femur Fracture 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 1/224 (0.4%)
    Pelvic Fracture 0/160 (0%) 0/195 (0%) 0/227 (0%) 0/217 (0%) 1/224 (0.4%)
    Rib Fracture 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 1/217 (0.5%) 1/224 (0.4%)
    Road Traffic Accident 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 1/224 (0.4%)
    Upper Limb Fracture 0/160 (0%) 0/195 (0%) 0/227 (0%) 0/217 (0%) 1/224 (0.4%)
    Clavicle Fracture 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Excoriation 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Hip Fracture 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Scapula Fracture 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Shunt Malfunction 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Splenic Rupture 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Investigations
    Weight Decreased 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Metabolism and nutrition disorders
    Hypocalcaemia 0/160 (0%) 0/195 (0%) 0/227 (0%) 0/217 (0%) 1/224 (0.4%)
    Obesity 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 1/224 (0.4%)
    Anorexia 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Dehydration 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Musculoskeletal and connective tissue disorders
    Back Pain 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 1/224 (0.4%)
    Lumbar Spinal Stenosis 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 1/224 (0.4%)
    Arthritis 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Myalgia 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Osteoarthritis 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 3/217 (1.4%) 0/224 (0%)
    Spinal Column Stenosis 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder Cancer 0/160 (0%) 0/195 (0%) 0/227 (0%) 0/217 (0%) 1/224 (0.4%)
    Breast Cancer 0/160 (0%) 0/195 (0%) 0/227 (0%) 0/217 (0%) 1/224 (0.4%)
    Prostate Cancer 1/93 (1.1%) 0/101 (0%) 0/131 (0%) 0/118 (0%) 1/119 (0.8%)
    Adenosquamous Cell Lung Cancer 0/160 (0%) 1/195 (0.5%) 0/227 (0%) 0/217 (0%) 0/224 (0%)
    Bladder Neoplasm 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Breast Cancer Metastatic 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Lung Cancer Metastatic 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Metastasis 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Rectal Cancer 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Ureteric Cancer 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Nervous system disorders
    Subarachnoid Haemorrhage 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 1/224 (0.4%)
    Syncope 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 1/224 (0.4%)
    Transient Ischaemic Attack 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 1/224 (0.4%)
    Convulsion 0/160 (0%) 1/195 (0.5%) 0/227 (0%) 0/217 (0%) 0/224 (0%)
    Coordination Abnormal 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Hydrocephalus 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Loss Of Consciousness 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Radiculitis 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Psychiatric disorders
    Confusional State 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Depression 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Renal and urinary disorders
    Urinary Retention 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia 0/93 (0%) 0/101 (0%) 1/131 (0.8%) 0/118 (0%) 1/119 (0.8%)
    Respiratory, thoracic and mediastinal disorders
    Chronic Obstructive Pulmonary Disease 0/160 (0%) 0/195 (0%) 0/227 (0%) 0/217 (0%) 1/224 (0.4%)
    Asthma 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Haemopneumothorax 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Surgical and medical procedures
    Knee Arthroplasty 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Vascular disorders
    Aneurysm Ruptured 0/160 (0%) 0/195 (0%) 1/227 (0.4%) 0/217 (0%) 0/224 (0%)
    Aortic Aneurysm Rupture 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Arterial Occlusive Disease 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Arteriosclerosis 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Femoral Artery Occlusion 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Hypertension 0/160 (0%) 1/195 (0.5%) 0/227 (0%) 0/217 (0%) 0/224 (0%)
    Thrombosis 0/160 (0%) 0/195 (0%) 0/227 (0%) 1/217 (0.5%) 0/224 (0%)
    Other (Not Including Serious) Adverse Events
    Placebo Desmopressin Melt 10 μg Desmopressin Melt 25 μg Desmopressin Melt 50 μg Desmopressin Melt 100 μg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 64/160 (40%) 113/195 (57.9%) 147/227 (64.8%) 154/217 (71%) 146/224 (65.2%)
    Gastrointestinal disorders
    Dry Mouth 44/160 (27.5%) 70/195 (35.9%) 62/227 (27.3%) 64/217 (29.5%) 61/224 (27.2%)
    Nausea 1/160 (0.6%) 10/195 (5.1%) 13/227 (5.7%) 15/217 (6.9%) 16/224 (7.1%)
    Diarrhoea 2/160 (1.3%) 12/195 (6.2%) 14/227 (6.2%) 15/217 (6.9%) 7/224 (3.1%)
    General disorders
    Fatigue 2/160 (1.3%) 13/195 (6.7%) 4/227 (1.8%) 8/217 (3.7%) 7/224 (3.1%)
    Oedema Peripheral 0/160 (0%) 6/195 (3.1%) 2/227 (0.9%) 11/217 (5.1%) 10/224 (4.5%)
    Infections and infestations
    Upper Respiratory Tract Infection 2/160 (1.3%) 12/195 (6.2%) 22/227 (9.7%) 19/217 (8.8%) 26/224 (11.6%)
    Nasopharyngitis 3/160 (1.9%) 10/195 (5.1%) 18/227 (7.9%) 15/217 (6.9%) 20/224 (8.9%)
    Urinary Tract Infection 1/160 (0.6%) 10/195 (5.1%) 19/227 (8.4%) 15/217 (6.9%) 15/224 (6.7%)
    Bronchitis 0/160 (0%) 5/195 (2.6%) 13/227 (5.7%) 12/217 (5.5%) 13/224 (5.8%)
    Sinusitis 1/160 (0.6%) 9/195 (4.6%) 13/227 (5.7%) 10/217 (4.6%) 9/224 (4%)
    Influenza 0/160 (0%) 3/195 (1.5%) 8/227 (3.5%) 11/217 (5.1%) 7/224 (3.1%)
    Metabolism and nutrition disorders
    Hyponatraemia 2/160 (1.3%) 3/195 (1.5%) 5/227 (2.2%) 15/217 (6.9%) 15/224 (6.7%)
    Musculoskeletal and connective tissue disorders
    Back Pain 0/160 (0%) 7/195 (3.6%) 15/227 (6.6%) 20/217 (9.2%) 11/224 (4.9%)
    Pain In Extremity 1/160 (0.6%) 3/195 (1.5%) 12/227 (5.3%) 4/217 (1.8%) 11/224 (4.9%)
    Nervous system disorders
    Headache 9/160 (5.6%) 17/195 (8.7%) 17/227 (7.5%) 19/217 (8.8%) 25/224 (11.2%)
    Dizziness 1/160 (0.6%) 9/195 (4.6%) 10/227 (4.4%) 11/217 (5.1%) 11/224 (4.9%)
    Psychiatric disorders
    Insomnia 1/160 (0.6%) 8/195 (4.1%) 7/227 (3.1%) 13/217 (6%) 13/224 (5.8%)
    Respiratory, thoracic and mediastinal disorders
    Cough 0/160 (0%) 1/195 (0.5%) 8/227 (3.5%) 12/217 (5.5%) 12/224 (5.4%)
    Vascular disorders
    Hypertension 1/160 (0.6%) 8/195 (4.1%) 21/227 (9.3%) 15/217 (6.9%) 14/224 (6.3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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

    Name/Title Clinical Development Support
    Organization Ferring Pharmaceuticals
    Phone
    Email DK0-Disclosure@ferring.com
    Responsible Party:
    Ferring Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00615836
    Other Study ID Numbers:
    • FE992026 CS31
    First Posted:
    Feb 14, 2008
    Last Update Posted:
    Dec 15, 2015
    Last Verified:
    Nov 1, 2015