NocturiaPhase 3NCT00615836
An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults
A Phase 3 study testing Desmopressin Melt in people with Nocturia, run by Ferring Pharmaceuticals at 73 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nocturia
- What is being tested?
- Desmopressin Melt
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 73 sitesin 2 countries
- Study dates
- Dec 2007to May 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Patients using loop diuretics (furosemide, torsemide, ethacrynic acid).
Trial locations and contacts
73 sites in 2 countries.
73 sites in 2 countries
United States64 sites
Urology Group of New Mexico, PC
Albuquerque, New Mexico, 87109
Advanced Urology Medical Center
Anaheim, California, 92801
South Florida Medical Research
Aventura, Florida, 33180
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, 19004
Impact Clinical Trials
Beverly Hills, California, 90211
Investigational site - Adult & Pediatric Urology
Carmel, New York, 10512
Radiant Research, Inc
Chicago, Illinois, 60654
Radiant Research Inc.
Cincinnati, Ohio, 45249
Women's Health Research Group, LLC
Clearwater, Florida, 33759
Southeastern Medical Research Institute
Columbus, Georgia, 31904
Advanced Research Associates
Corpus Christi, Texas, 78414
Urology Associates PC
Denver, Colorado, 80210
Downtown Women's Health Care
Denver, Colorado, 80218
Genitourinary Surgical Consultants
Denver, Colorado, 80220
Investigational site
Dunwoody, Georgia, 30338
Radiant Research, Minneapolis
Edina, Minnesota, 55435
Central Jersey Medical Research Center
Elizabeth, New Jersey, 07202
AccuMed Research Associates
Garden City, New York, 11530
PharmQuest
Greensboro, North Carolina, 27408
Radiant Research, Greer
Greer, South Carolina, 29651
Investigational site - NationsMed Clinical Research
Houston, Texas, 77004
Accelovance
Houston, Texas, 77024
Regional Medical Center and Diagnostic
Humble, Texas, 77338
Holston Medical Group
Kingsport, Tennessee, 37660
Sheldon J Freedman Ltd
Las Vegas, Nevada
Lawrenceville Urology, P.A. DBA
Lawrenceville, New Jersey, 08648
Women's Clinic of Lincoln, P.C.
Lincoln, Nebraska, 68510
Arkansas Primary Care Clinic, PA
Little Rock, Arkansas, 72204
Benchmark Research
Metairie, Louisiana, 70006
Connecticut Clinical Research Center, LLC
Middlebury, Connecticut, 06762
Radiant Research - Akron
Mogadore, Ohio, 44260
Palmetto Medical Research
Mt. Pleasant, South Carolina, 29464
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
University Urology Associates
New York, New York, 10016
Upstate Urology
New York, New York, 12206-1092
California Professional Research
Newport Beach, California, 92660
Radiant Research, Kansas City
Overland Park, Kansas, 66202
Accelovance
Peoria, Illinois, 61602
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, 19114
Radiant Research - St. Petersburg
Pinellas Park, Florida, 33781
Sunrise Medical Research
Plantation, Florida, 33324
Hudson Valley Urology, PC
Poughkeepsie, New York, 12601
Virginia Urology
Richmond, Virginia, 23235
Innovative Clinical Trials
San Antonio, Texas, 78229
Radiant Research San Antonio
San Antonio, Texas, 78229
IMED Research, P.A.
San Antonio, Texas, 78258
San Diego Uro-Reseach
San Diego, California, 92103
Radiant Research
Santa Rosa, California, 95405
Radiant Research
Scottsdale, Arizona, 85251
Women's Clinical Research Center
Seattle, Washington, 98105
Seattle Urology Research Center
Seattle, Washington, 98166
Regional Urology, LLC
Shreveport, Louisiana, 71106
FutureCare Studies, Inc.
Springfield, Massachusetts, 01103
Radiant Research, Inc.
St Louis, Missouri, 63141
NationsMed
Stafford, Texas
Radiant Research
Stuart, Florida, 34996
Tampa Bay Urology
Tampa, Florida, 33607
West Coast Clinical Research
Tarzana, California, 91356
Western Clinical Research
Torrance, California, 90505
Urology of Virginia PC
Virginia Beach, Virginia, 23454
Radiant Research
West Palm Beach, Florida, 33407
Advanced Clinical Concepts
West Readings, Pennsylvania, 19611
New Hanover Medical Research
Wilmington, North Carolina, 28401
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103
Canada9 sites
The Male/Female Health and Research
Barrie, Ontario, L4M 7G1
Brantford Urology Research
Brantford, Ontario, N3R 4N3
Investigational site - Professional Corporation
Fredericton, New Brunswick, E3B 5B8
Guelph Urology Associates
Guelph, Ontario, N1H 5J1
Southern Interior Medical Research Inc.
Kelowna, British Columbia, V1Y-2H4
Investigational site
North Bay, Ontario, P1B 7K8
The Fe/Male Health Centres
Oakville, Ontario, L6H 3P1
Can-Med Clinical Research Inc.
Victoria, British Columbia, V8T 5G1
Investigational site - Clinical Research
Victoria, British Columbia, V8V 3N1
About this study
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
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.
Read the 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.
- Conditions
- Nocturia
- Being tested
- Desmopressin Melt
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desmopressin MeltDrug
Also called Minirin® Melt, Nocturin®, FE992026
An orally disintegrating tablet of desmopressin administered under the tongue (sublingually), without water.
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin Melt 10 μg | Experimental | 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). Receives: Drug: Desmopressin Melt |
| Desmopressin Melt 25 μg | Experimental | 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. Receives: Drug: Desmopressin Melt |
| Desmopressin Melt 50 μg | Experimental | 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. Receives: Drug: Desmopressin Melt |
| Desmopressin Melt 100 μg | Experimental | 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. Receives: Drug: Desmopressin Melt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Number of Nocturnal Voids
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.
Measured: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.
Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids
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.
Measured: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.
Change From Baseline in Initial Period of Undisturbed Sleep
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.
Measured: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.
Secondary outcomes (10)
Change From Baseline in Total Sleep Time
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.
Measured: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.
Change From Baseline in International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) Nighttime Urination Bother Score
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.
Measured: 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)
Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score
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.
Measured: 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)
Change From Baseline in NQoL Bother/Concern Domain Score
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.
Measured: 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)
Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score
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.
Measured: 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)
Change From Baseline in the Nocturia Quality of Life (NQoL) Global Quality of Life Score
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.
Measured: 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)
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score
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.
Measured: 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)
Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Mental Component Summary Score
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.
Measured: 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)
Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Physical Component Summary Score
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.
Measured: 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)
Participants With Treatment-Emergent Adverse Events (AEs)
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.
Measured: From first dose of study drug in Study CS29 until the end of study CS31 (up to 35 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NocturiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615836
- Sponsor's protocol ID
- FE992026 CS31
- Status last verified
- Nov 2015
- First submitted
- 18 Jan 2008
- Last updated
- 15 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Juul KV, Klein BM, Sandstrom R, Erichsen L, Norgaard JP. Gender difference in antidiuretic response to desmopressin. Am J Physiol Renal Physiol. 2011 May;300(5):F1116-22. doi: 10.1152/ajprenal.00741.2010. Epub 2011 Mar 2.
PubMed 21367921
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00615836
- Acronym / sponsor ID
- FE992026 CS31
- Conditions
- Nocturia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Feb 2008 (estimated)
- Results
- Posted 15 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Desmopressin Melt 10 μg | Experimental | Drug: Desmopressin MeltParticipants 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). |
| Desmopressin Melt 25 μg | Experimental | Drug: Desmopressin MeltParticipants 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. |
| Desmopressin Melt 50 μg | Experimental | Drug: Desmopressin MeltParticipants 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. |
| Desmopressin Melt 100 μg | Experimental | Drug: Desmopressin MeltParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients using loop diuretics (furosemide, torsemide, ethacrynic acid).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desmopressin MeltAlso: Minirin® Melt, Nocturin®, FE992026An orally disintegrating tablet of desmopressin administered under the tongue (sublingually), without water. | Drug | Desmopressin Melt 10 μg, Desmopressin Melt 100 μg, Desmopressin Melt 25 μg, Desmopressin Melt 50 μg |
Primary outcome
Change From Baseline in Mean Number of Nocturnal Voids
Time frame: 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.
Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids
Time frame: 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.
Change From Baseline in Initial Period of Undisturbed Sleep
Time frame: 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.
10 secondary outcomes
Change From Baseline in Total Sleep Time
Time frame: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.
Change From Baseline in International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) Nighttime Urination Bother Score
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)
Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score
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)
Change From Baseline in NQoL Bother/Concern Domain Score
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)
Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score
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)
Change From Baseline in the Nocturia Quality of Life (NQoL) Global Quality of Life Score
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)
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score
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)
Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Mental Component Summary Score
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)
Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Physical Component Summary Score
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)
Participants With Treatment-Emergent Adverse Events (AEs)
Time frame: From first dose of study drug in Study CS29 until the end of study CS31 (up to 35 months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21367921Juul KV, Klein BM, Sandstrom R, Erichsen L, Norgaard JP. Gender difference in antidiuretic response to desmopressin. Am J Physiol Renal Physiol. 2011 May;300(5):F1116-22. doi: 10.1152/ajprenal.00741.2010. Epub 2011 Mar 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
73 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desmopressin Melt in people with Nocturia, run by Ferring Pharmaceuticals at 73 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mean Number of Nocturnal Voids (time frame: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00615836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2015.