Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

29 september 2015 bijgewerkt door: Ferring Pharmaceuticals

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

799

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y-2H4
        • Southern Interior Medical Center
      • Victoria, British Columbia, Canada, V8T 5G1
        • Can-Med Clinical Research Inc.
      • Victoria, British Columbia, Canada, V8V 3N1
        • Investigational site - Clinical Research
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 5B8
        • Investigational site - Professional Corporation
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • The Male/Female Health and Reserach
      • Brantford, Ontario, Canada, N3R 4N3
        • Brantford Urology Research
      • Guelph, Ontario, Canada, N1H 5J1
        • Guelph Urology Associates
      • North Bay, Ontario, Canada, P1B 4Z2
        • Investigational Site
      • Oakville, Ontario, Canada, L6H 3P1
        • The Fe/Male Health Centres
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35209
        • Radiant Research
    • Arizona
      • Scottsdale, Arizona, Verenigde Staten, 85251
        • Radiant Research
    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72204
        • Arkansas Primary Care Clinic
    • California
      • Anaheim, California, Verenigde Staten, 92801
        • Advanced Urology Medical Center
      • Beverly Hills, California, Verenigde Staten, 90211
        • Impact Clinical Trials
      • Long Beach, California, Verenigde Staten, 90806
        • Atlantic Urology Medical Group
      • Newport Beach, California, Verenigde Staten, 92660
        • California Professional Research
      • San Diego, California, Verenigde Staten, 92103
        • San Diego Uro-Research
      • Santa Rosa, California, Verenigde Staten, 95404
        • Radiant Research
      • Tarzana, California, Verenigde Staten, 91356
        • West Coast Clinical Research
      • Torrance, California, Verenigde Staten, 90505
        • Western Clinical Research
    • Colorado
      • Denver, Colorado, Verenigde Staten, 80218
        • Downtown Women's Health Care
      • Denver, Colorado, Verenigde Staten, 80220
        • Genitourinary Surgical Consultants
      • Denver, Colorado, Verenigde Staten, 80210
        • Urology Associates PC
    • Connecticut
      • Middlebury, Connecticut, Verenigde Staten, 06762
        • Connecticut Clinical Research Center, LLC
    • Florida
      • Aventura, Florida, Verenigde Staten, 33180
        • South Florida Medical Research
      • Clearwater, Florida, Verenigde Staten, 33759
        • Women's Medical Research Group, LLC
      • Miami, Florida, Verenigde Staten, 33145
        • Medsearch Professional Group
      • Plantation, Florida, Verenigde Staten, 33324
        • Sunrise Medical Research
      • Stuart, Florida, Verenigde Staten, 34996
        • Radiant Research
      • Tallahassee, Florida, Verenigde Staten, 32308
        • Southeastern Research Group, Inc.
      • Tampa, Florida, Verenigde Staten, 33607
        • Tampa Bay Urology
      • West Palm Beach, Florida, Verenigde Staten, 33407
        • Radiant Research
    • Georgia
      • Columbus, Georgia, Verenigde Staten, 31904
        • Southeastern Medical Research Institute
      • Dunwoody, Georgia, Verenigde Staten, 30338
        • Investigational site - PC
    • Illinois
      • Peoria, Illinois, Verenigde Staten, 61602
        • Accelovance
    • Kansas
      • Overland park, Kansas, Verenigde Staten, 66202
        • Radiant Research, Kansas City
    • Louisiana
      • Metairie, Louisiana, Verenigde Staten, 70006
        • Benchmark Research
      • Shreveport, Louisiana, Verenigde Staten, 71106
        • Regional Urology, LLC
      • Shreveport, Louisiana, Verenigde Staten, 71111
        • Pierremont Women's Clinic
    • Massachusetts
      • Springfield, Massachusetts, Verenigde Staten, 01103
        • FutureCare Studies, Inc.
    • Missouri
      • St. Louis, Missouri, Verenigde Staten, 63141
        • Radiant Research Inc.
    • Nebraska
      • Lincoln, Nebraska, Verenigde Staten, 68510
        • Women's Clinic of Lincoln, P.C
    • Nevada
      • Las Vegas, Nevada, Verenigde Staten, 89109
        • Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, Verenigde Staten, 08648
        • Lawrenceville Urology
      • Lawrenceville, New Jersey, Verenigde Staten, 08648
        • AdvanceMed Research
      • Morristown, New Jersey, Verenigde Staten, 07960
        • Morristown Urology
    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten, 87109
        • Urology Group of New Mexico, PC
    • New York
      • Albany, New York, Verenigde Staten, 12206
        • Upstate Urology
      • Carmel, New York, Verenigde Staten, 10512
        • Investigational site - Adult & Pediatric Urology
      • Garden City, New York, Verenigde Staten, 11530
        • AccuMed Research Associates
      • New York, New York, Verenigde Staten, 10016
        • University Urology Associates
      • Suffern, New York, Verenigde Staten, 10901
        • Ferring Pharmaceutical Inc
    • North Carolina
      • Concord, North Carolina, Verenigde Staten, 28025
        • Northeast Urology Research
      • Greensboro, North Carolina, Verenigde Staten, 27401
        • PharmQuest
      • Wilmington, North Carolina, Verenigde Staten, 28401
        • New Hanover Medical Research
      • Winston-Salem, North Carolina, Verenigde Staten, 27103
        • Piedmont Medical Research Associates
    • Ohio
      • Cincinnati, Ohio, Verenigde Staten, 45249
        • Radiant Research
      • Mogadore, Ohio, Verenigde Staten, 44260
        • Radiant Research - Akron
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, Verenigde Staten, 19004
        • Urologic Consultants of SE PA
      • Philadelphia, Pennsylvania, Verenigde Staten, 19115
        • Radiant Research
      • Philadelphia, Pennsylvania, Verenigde Staten, 19114
        • Philadelphia Clinical Research, LLC
      • Reading, Pennsylvania, Verenigde Staten, 19611
        • Advanced Clinical Concepts
    • South Carolina
      • Greenville, South Carolina, Verenigde Staten, 29605
        • University Medical Group
      • Greer, South Carolina, Verenigde Staten, 29651
        • Radiant Research, Greer
      • Mt. Pleasant, South Carolina, Verenigde Staten, 29464
        • Palmetto Medical Research
      • Myrtle Beach, South Carolina, Verenigde Staten, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Kingsport, Tennessee, Verenigde Staten, 37660
        • Holston Medical Group
      • Nashville, Tennessee, Verenigde Staten, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Corpus Christi, Texas, Verenigde Staten, 78414
        • Advanced Research Associates
      • Dallas, Texas, Verenigde Staten, 75231
        • Health Central Women's Care
      • Houston, Texas, Verenigde Staten, 77024
        • Accelovance
      • Humble, Texas, Verenigde Staten, 77338
        • Regional Medical Center and Diagnostic
      • San Antonio, Texas, Verenigde Staten, 78229
        • Urology San Antonio Research, PA
      • San Antonio, Texas, Verenigde Staten, 78228
        • Radiant Research San Antonio
    • Virginia
      • Richmond, Virginia, Verenigde Staten, 23235
        • Virginia Urology Center
      • Virginia Beach, Virginia, Verenigde Staten, 23454
        • Urology of Virginia PC
    • Washington
      • Seattle, Washington, Verenigde Staten, 98105
        • Women's Clinical Research Center
      • Seattle, Washington, Verenigde Staten, 98166
        • Seattle Urology Research Center
      • Seattle, Washington, Verenigde Staten, 98166
        • Investigational site - Medical Professional

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria

  1. Written informed consent prior to the performance of any study-related activity.
  2. 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.

Exclusion Criteria:

Males:

  1. 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

  2. Surgical treatment for bladder outlet obstruction/benign prostatic hyperplasia performed within the past 6 months

    Females:

  3. Pregnancy. Females of reproductive age must have documentation of a reliable method of contraception.
  4. Use of pessary for pelvic prolapse.

  5. Unexplained pelvic mass.

    Males and Females:

  6. 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.
  7. Current or past urologic malignancy (e.g., bladder cancer, prostate cancer).
  8. Clinical evidence of current genitourinary tract pathology that could interfere with voiding.
  9. History of neurogenic detrusor activity (previously known as detrusor hyperreflexia).
  10. Suspicion or evidence of cardiac failure.
  11. Uncontrolled hypertension.
  12. Uncontrolled diabetes mellitus.
  13. Renal insufficiency. Serum creatinine must be within normal limits and estimated glomerular filtration rate (eGFR) >=60 mL/min.
  14. 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.
  15. Hyponatremia. Serum sodium level must be within normal limits
  16. Syndrome of Inappropriate antidiuretic hormone secretion (SIADH).
  17. Diabetes insipidus (urine output > 40 ml/kg over 24 hours) as determined by the 3-day voiding diary.
  18. Psychogenic or habitual polydipsia

  19. Obstructive sleep apnea

    Other

  20. Known alcohol or substance abuse
  21. Work or lifestyle potentially interfering with regular nighttime sleep (e.g., shift workers)
  22. Previous desmopressin treatment for nocturia.
  23. 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.
  24. 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.
  25. 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo
Participants 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).
Geneesmiddel: Placebo
Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.
Experimenteel: desmopressin melt 10 μg
Participants 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).
Geneesmiddel: desmopressin acetate
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
Andere namen:
  • FE992026
  • Nocturin®
  • Minirin® smelt
Experimenteel: desmopressin melt 25 μg
Participants 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).
Geneesmiddel: desmopressin acetate
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
Andere namen:
  • FE992026
  • Nocturin®
  • Minirin® smelt
Experimenteel: desmopressin melt 50 μg
Participants 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).
Geneesmiddel: desmopressin acetate
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
Andere namen:
  • FE992026
  • Nocturin®
  • Minirin® smelt
Experimenteel: desmopressin melt 100 μg
Participants 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).
Geneesmiddel: desmopressin acetate
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
Andere namen:
  • FE992026
  • Nocturin®
  • Minirin® smelt

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4
Tijdsspanne: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

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.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids at Week 4
Tijdsspanne: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Tijdsspanne: - Week 3 to Day 1 (Baseline), 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.
- Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169
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
Tijdsspanne: - Week 3 to Day 1 (Baseline), 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.
- Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169
Part I: Change From Baseline in Total Reported Sleep Time at Week 4
Tijdsspanne: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Total sleep time was recorded by participants in study diaries.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Change From Baseline in Initial Period of Undisturbed Sleep at Week 4
Tijdsspanne: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
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.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Change From Baseline in Quality of Life Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) at Week 4
Tijdsspanne: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
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.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Change From Baseline in the Two Domain Scores of the Nocturia Quality of Life (NQoL) Questionnaire at Week 4
Tijdsspanne: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
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.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
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
Tijdsspanne: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
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.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
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
Tijdsspanne: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
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.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I
Tijdsspanne: Day 1 up to Week 4 (end of 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.
Day 1 up to Week 4 (end of Part I)
Part II: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part II
Tijdsspanne: Week 5 up to Day 169
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.
Week 5 up to Day 169

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ferring Pharmaceuticals

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2007

Primaire voltooiing (Werkelijk)

1 februari 2008

Studie voltooiing (Werkelijk)

1 februari 2008

Studieregistratiedata

Eerst ingediend

22 mei 2007

Eerst ingediend dat voldeed aan de QC-criteria

22 mei 2007

Eerst geplaatst (Schatting)

23 mei 2007

Updates van studierecords

Laatste update geplaatst (Schatting)

1 november 2015

Laatste update ingediend die voldeed aan QC-criteria

29 september 2015

Laatst geverifieerd

1 september 2015

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FE992026 CS29

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren