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NocturiaPhase 3NCT00477490

Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

A Phase 3 study testing desmopressin acetate in people with Nocturia, run by Ferring Pharmaceuticals at 80 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to investigate the 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 acetate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
799 participants
Where
80 sitesin 2 countries
Study dates
May 2007to Feb 2008
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.
  • Patients 18 years and older with an average of ≥ 2 nocturnal voids per night as determined by a 3 day frequency-volume chart during the screening period.

Who cannot join

  • Males:
  • Clinical suspicion of bladder outlet obstruction and/or urine flow < 5 ml/s. If medical history and/or physical examination suggest bladder outlet obstruction, uroflowmetry should be performed to confirm the diagnosis
  • Surgical treatment for bladder outlet obstruction/benign prostatic hyperplasia performed within the past 6 months
  • Females:
  • Pregnancy. Females of reproductive age must have documentation of a reliable method of contraception.
  • Use of pessary for pelvic prolapse.
Show all 40Show fewer
  • Unexplained pelvic mass.
  • Males and Females:
  • Clinical suspicion of urinary retention and/or post void residual volume > 150 ml. If medical history and/or physical examination suggest urinary retention, bladder ultrasound or catheterization should be performed to confirm the diagnosis.
  • Current or past urologic malignancy (e.g., bladder cancer, prostate cancer).
  • Clinical evidence of current genitourinary tract pathology that could interfere with voiding.
  • History of neurogenic detrusor activity (previously known as detrusor hyperreflexia).
  • Suspicion or evidence of cardiac failure.
  • Uncontrolled hypertension.
  • Uncontrolled diabetes mellitus.
  • Renal insufficiency. Serum creatinine must be within normal limits and estimated glomerular filtration rate (eGFR) >=60 mL/min.
  • Active hepatic and/or biliary disease. Aspartate transaminase (AST) or alanine transaminase (ALT) should not be >2 times the upper limit of normal. Total bilirubin should not be > 1.5 mg/dL.
  • Hyponatremia. Serum sodium level must be within normal limits
  • Syndrome of Inappropriate antidiuretic hormone secretion (SIADH).
  • Diabetes insipidus (urine output > 40 ml/kg over 24 hours) as determined by the 3-day voiding diary.
  • Psychogenic or habitual polydipsia
  • Obstructive sleep apnea
  • Other
  • Known alcohol or substance abuse
  • Work or lifestyle potentially interfering with regular nighttime sleep (e.g., shift workers)
  • Previous desmopressin treatment for nocturia.
  • Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity or language barrier that, in the judgment of the investigator, could impair patient participation in the trial.
  • Use of loop diuretics (furosemide, torsemide, ethacrynic acid). Other classes of diuretics (thiazides, triamterene, chlorthalidone, amiloride, indapamide) were permitted, either as monotherapy or combination therapy. Subjects using a diuretic were to be encouraged to take it in the morning, if medically feasible.
  • Use of any other investigational drug within 30 days of screening.
  • Concomitant Medications
  • The following medications are permitted provided that the subject has been on a stable dose for the 3 months prior to the screening date (i.e. treatment has not been initiated or discontinued and there has been no change in dose):
  • Alpha-blockers: Cardura (doxazosin); Flomax (tamsulosin); Hytrin (terazosin); Uroxatral (alfuzosin)
  • 5 alpha-reductase inhibitors: Avodart (dutasteride); Proscar (finasteride)
  • Antispasmodic, anticholinergic, antimuscarinic therapy for overactive bladder: Detrol, Detrol LA (tolterodine); Ditropan, Ditropan XL (oxybutynin); Enablex (darifenacin); Levsin(hyoscyamine); Oxytrol transdermal (oxybutynin); Sanctura (trospium); Vesicare (solifenacin)
  • Sedative/hypnotic medications for sleep disorders
  • Selective serotonin and mixed norepinephrine/serotonin reuptake inhibitors: Celexa (citalopram); Cymbalta (duloxetine); Effexor (venlafaxine); Lexapro (escitalopram); Paxil(paroxetine); Prozac (fluoxetine); Zoloft (sertraline)
  • Chronic use of nonsteroidal anti-inflammatory agents
  • Diabinese (chlorpropamide)
  • Carbamazepine (carbatrol/tegretol)
  • Amiodarone

Trial locations and contacts

80 sites in 2 countries.

80 sites in 2 countries

United States70 sites

  • Upstate Urology

    Albany, New York, 12206

  • 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

  • Radiant Research

    Birmingham, Alabama, 35209

  • Investigational site - Adult & Pediatric Urology

    Carmel, New York, 10512

  • Radiant Research

    Cincinnati, Ohio, 45249

  • Women's Medical Research Group, LLC

    Clearwater, Florida, 33759

  • Southeastern Medical Research Institute

    Columbus, Georgia, 31904

  • Northeast Urology Research

    Concord, North Carolina, 28025

  • Advanced Research Associates

    Corpus Christi, Texas, 78414

  • Health Central Women's Care

    Dallas, Texas, 75231

  • Urology Associates PC

    Denver, Colorado, 80210

  • Downtown Women's Health Care

    Denver, Colorado, 80218

  • Genitourinary Surgical Consultants

    Denver, Colorado, 80220

  • Investigational site - PC

    Dunwoody, Georgia, 30338

  • AccuMed Research Associates

    Garden City, New York, 11530

  • PharmQuest

    Greensboro, North Carolina, 27401

  • University Medical Group

    Greenville, South Carolina, 29605

  • Radiant Research, Greer

    Greer, South Carolina, 29651

  • Accelovance

    Houston, Texas, 77024

  • Regional Medical Center and Diagnostic

    Humble, Texas, 77338

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Investigational site

    Las Vegas, Nevada, 89109

  • AdvanceMed Research

    Lawrenceville, New Jersey, 08648

  • Lawrenceville Urology

    Lawrenceville, New Jersey, 08648

  • Women's Clinic of Lincoln, P.C

    Lincoln, Nebraska, 68510

  • Arkansas Primary Care Clinic

    Little Rock, Arkansas, 72204

  • Atlantic Urology Medical Group

    Long Beach, California, 90806

  • Benchmark Research

    Metairie, Louisiana, 70006

  • Medsearch Professional Group

    Miami, Florida, 33145

  • Connecticut Clinical Research Center, LLC

    Middlebury, Connecticut, 06762

  • Radiant Research - Akron

    Mogadore, Ohio, 44260

  • Morristown Urology

    Morristown, New Jersey, 07960

  • Palmetto Medical Research

    Mt. Pleasant, South Carolina, 29464

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • University Urology Associates

    New York, New York, 10016

  • 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

    Philadelphia, Pennsylvania, 19115

  • Sunrise Medical Research

    Plantation, Florida, 33324

  • Advanced Clinical Concepts

    Reading, Pennsylvania, 19611

  • Virginia Urology Center

    Richmond, Virginia, 23235

  • Radiant Research San Antonio

    San Antonio, Texas, 78228

  • Urology San Antonio Research, PA

    San Antonio, Texas, 78229

  • San Diego Uro-Research

    San Diego, California, 92103

  • Radiant Research

    Santa Rosa, California, 95404

  • Radiant Research

    Scottsdale, Arizona, 85251

  • Women's Clinical Research Center

    Seattle, Washington, 98105

  • Investigational site - Medical Professional

    Seattle, Washington, 98166

  • Seattle Urology Research Center

    Seattle, Washington, 98166

  • Regional Urology, LLC

    Shreveport, Louisiana, 71106

  • Pierremont Women's Clinic

    Shreveport, Louisiana, 71111

  • FutureCare Studies, Inc.

    Springfield, Massachusetts, 01103

  • Radiant Research Inc.

    St Louis, Missouri, 63141

  • Radiant Research

    Stuart, Florida, 34996

  • Ferring Pharmaceutical Inc

    Suffern, New York, 10901

  • Southeastern Research Group, Inc.

    Tallahassee, Florida, 32308

  • 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

  • New Hanover Medical Research

    Wilmington, North Carolina, 28401

  • Piedmont Medical Research Associates

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada10 sites

  • The Male/Female Health and Reserach

    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 Center

    Kelowna, British Columbia, V1Y-2H4

  • Investigational site

    North Bay, Ontario, P1B 4Z2

  • The Fe/Male Health Centres

    Oakville, Ontario, L6H 3P1

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Can-Med Clinical Research Inc.

    Victoria, British Columbia, V8T 5G1

  • Investigational site - Clinical Research

    Victoria, British Columbia, V8V 3N1

Other trials in Canada

About this study

Official title: 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

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

Conditions
Nocturia
Being tested
desmopressin acetate, Placebo
Medical subject headings
Nocturia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • desmopressin acetateDrug

    Also called Minirin® Melt, Nocturin®, FE992026

    Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg

  • PlaceboDrug

    Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.

Study groups in NCT00477490
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants took a placebo 'melt' for 28 days to complete part 1 of the study. In part 2, placebo patients were randomized to one of the other 4 treatment arms based on assignments predetermined at the initial randomization, to receive active desmopressin melt for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
Receives: Drug: Placebo
desmopressin melt 10 μgExperimentalParticipants took desmopressin melt 10 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
Receives: Drug: desmopressin acetate
desmopressin melt 25 μgExperimentalParticipants took desmopressin melt 25 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
Receives: Drug: desmopressin acetate
desmopressin melt 50 μgExperimentalParticipants took desmopressin melt 50 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
Receives: Drug: desmopressin acetate
desmopressin melt 100 μgExperimentalParticipants will take desmopressin melt 100 μg for 28 days to complete part 1 of the study. Participants will continue on this dose in part 2 of the study for between 1-6 months (until the database for part 1 is locked and treatment is unblinded).
Receives: Drug: desmopressin acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4

    The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Day 1 and prior to the week 4 visit as recorded in participant diaries.

    This was the first co-primary outcome.

    Measured: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

  2. Part I: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids at Week 4

    Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to the end of Part I (week 4) in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries.

    This was the second co-primary outcome.

    Measured: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

Secondary outcomes (10)

  1. Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169

    Part II outcomes tested the durability of the effect observed in Part I. The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Part I baseline and prior to the Part II visit as recorded in participant diaries.

    Measured: - Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169

  2. Part II: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169

    Part II outcomes tested the durability of the effect observed in Part I. Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to Days 29, 57, 113 and 169 in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries.

    Measured: - Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169

  3. Part I: Change From Baseline in Total Reported Sleep Time at Week 4

    Total sleep time was recorded by participants in study diaries.

    Measured: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

  4. Part I: Change From Baseline in Initial Period of Undisturbed Sleep at Week 4

    Initial period of undisturbed sleep was the time elapsed from first falling asleep until either first void or morning arising. Data were captured in patient diaries.

    Measured: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

  5. Part I: Change From Baseline in Quality of Life Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) at Week 4

    The ICIQ-N is a self-administered questionnaire designed to assess the frequency and bother of daytime and nighttime urination. Subjects were asked to rate the degree of bother of daytime urination and nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower quality of life.

    Measured: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

  6. Part I: Change From Baseline in the Two Domain Scores of the Nocturia Quality of Life (NQoL) Questionnaire at Week 4

    The NQoL questionnaire is a self-administered questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The twelve core questions are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. Domain summary scores were calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better quality of life.

    Measured: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

  7. Part I: Change From Baseline in Quality of Sleep as Assessed by the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Week 4

    The PSQI is a self-administered 19-item questionnaire designed to assess sleep quality and disturbances. The global score ranges from 0 (better sleep quality) to 21 (worse sleep quality). Higher numbers indicate lower quality of life.

    Measured: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

  8. Part I: Change From Baseline in the Mental Health Summary and the Physical Health Summary of the Short Form-12 Version 2 (SF-12v2) at Week 4

    The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions. Data were analyzed using norm-based scoring and summarized along 2 dimensions: Physical Health Summary and Mental Health Summary. Each summary has a range from 0 (poor health) to 100 (highest level of health). Higher numbers indicate better quality of life.

    Measured: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

  9. Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I

    A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period.

    Measured: Day 1 up to Week 4 (end of Part I)

  10. Part II: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part II

    A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period.

    Measured: Week 5 up to Day 169

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
799 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00477490
Sponsor's protocol ID
FE992026 CS29
Status last verified
Sep 2015
First submitted
22 May 2007
Last updated
2 Nov 2015
Data monitoring committee
Yes

Publications

  • Juul KV, Klein BM, Norgaard JP. Long-term durability of the response to desmopressin in female and male nocturia patients. Neurourol Urodyn. 2013 Apr;32(4):363-70. doi: 10.1002/nau.22306. Epub 2012 Sep 12.

    PubMed 22972524

  • Weiss JP, Zinner NR, Klein BM, Norgaard JP. Desmopressin orally disintegrating tablet effectively reduces nocturia: results of a randomized, double-blind, placebo-controlled trial. Neurourol Urodyn. 2012 Apr;31(4):441-7. doi: 10.1002/nau.22243. Epub 2012 Mar 22.

    PubMed 22447415

  • Juul KV, Malmberg A, van der Meulen E, Walle JV, Norgaard JP. Low-dose desmopressin combined with serum sodium monitoring can prevent clinically significant hyponatraemia in patients treated for nocturia. BJU Int. 2017 May;119(5):776-784. doi: 10.1111/bju.13718. Epub 2016 Dec 10.

    PubMed 27862898

  • Bliwise DL, Holm-Larsen T, Goble S. Increases in duration of first uninterrupted sleep period are associated with improvements in PSQI-measured sleep quality. Sleep Med. 2014 Oct;15(10):1276-8. doi: 10.1016/j.sleep.2014.05.013. Epub 2014 Jun 13.

    PubMed 25172115

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing desmopressin acetate in people with Nocturia, run by Ferring Pharmaceuticals at 80 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 40 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 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 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. Some participants in this study may receive a placebo. 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 2 Nov 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?

Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4 (time frame: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)). The study lists 2 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 NCT00477490, which also lists 5 linked publications.

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 2 Nov 2015.

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