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Smoking Cessation Study In Healthy Adolescent Smokers

12 juli 2018 bijgewerkt door: Pfizer

A Twelve-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study With Follow-up Evaluating The Safety And Efficacy Of Varenicline For Smoking Cessation In Healthy Adolescent Smokers

The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

312

Fase

  • Fase 4

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
    • Ontario
      • Ajax, Ontario, Canada, L1Z 0M1
        • Kids Clinic
      • New Market, Ontario, Canada, L3Y 5G8
        • SKDS Research Inc.
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Private Practice of Robert J. Camargo
  • Georgië
      • Rustavi, Georgië, 3700
        • LTD" Rustavi Psychological Health Center"
  • Korea, republiek van
      • Daegu, Korea, republiek van, 41931
        • Keimyung University Dongsan Hospital
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Korea, republiek van, 14068
        • Hallym University Sacred Heart Hospital
      • Seongnam-si, Gyeonggi-do, Korea, republiek van, 13620
        • Seoul National University Bundang Hospital
      • Suwon-si, Gyeonggi-do, Korea, republiek van, 442 723
        • The Catholic University of Korea St. Vincent Hospital
  • Russische Federatie
      • Moscow, Russische Federatie, 119331
        • GBUZ City childrens out-patient clinic # 10 of Moscow
      • Murmansk, Russische Federatie, 183036
        • GOBUZ Murmansk Regional Narcology Dispensary
      • Novosibirsk, Russische Federatie, 630091
        • LLC City Neurological Center "Sibneuromed"
      • Saint-Petersburg, Russische Federatie, 190068
        • LLC " Alliance Biomedical - Russian Group"
      • Saint-Petersburg, Russische Federatie, 191025
        • LLC Medical Technologies
      • Saint-Petersburg, Russische Federatie, 192019
        • FSBI V.M.Bekhterev National Research Medical Center for Psychiatry and Neurology of RF MoH
      • Saint-Petersburg, Russische Federatie, 192148
        • LLC Medical Technologies
      • Saint-Petersburg, Russische Federatie, 197022
        • First St. Petersburg State Medical University
      • Samara, Russische Federatie, 443031
        • GBUZ Samara Regional Childrens Health camp Yunost
    • Leningrad Region
      • Village Novoe Devyatkino, Leningrad Region, Russische Federatie, 188661
        • Leningrad Regional Dispensary of Narcology
  • Taiwan
      • Kaohsiung City, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
      • New Taipei City, Taiwan, 220
        • Far Eastern Memorial Hospital
      • New Taipei City, Taiwan, 23561
        • Taipei Medical University Shuang Ho Hospital
      • Taichung city, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei City, Taiwan, 11217
        • Taipei Veterans General Hospital
  • Verenigde Staten
    • Alabama
      • Ozark, Alabama, Verenigde Staten, 36360
        • IICR, Inc. (DBA: International Institute of Clinical Research)
    • Arizona
      • Goodyear, Arizona, Verenigde Staten, 85395
        • Dedicated Clinical Research
    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72211
        • Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
    • California
      • Anaheim, California, Verenigde Staten, 92801
        • Anaheim Clinical Trials, LLC
      • La Habra, California, Verenigde Staten, 90631
        • Omega Clinical Trials, LLC
      • National City, California, Verenigde Staten, 91950
        • Synergy Clinical Research Center
      • Oakland, California, Verenigde Staten, 94607
        • Pacific Research Partners, LLC
      • Oceanside, California, Verenigde Staten, 92054
        • North County Clinical Research
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80045
        • University of Colorado Anschutz Medical Campus
      • Colorado Springs, Colorado, Verenigde Staten, 80910
        • MCB Clinical Research Centers
      • Denver, Colorado, Verenigde Staten, 80209
        • Western Affiliated Research Institute
    • Connecticut
      • New Haven, Connecticut, Verenigde Staten, 06520
        • Yale University
      • New Haven, Connecticut, Verenigde Staten, 06511
        • Connecticut Mental Health Center
      • New Haven, Connecticut, Verenigde Staten, 06511
        • Yale University, SATU
    • Florida
      • DeLand, Florida, Verenigde Staten, 32720
        • Avail Clinical Research, LLC
      • Kissimmee, Florida, Verenigde Staten, 34741
        • HOPE Clinical Research
      • Maitland, Florida, Verenigde Staten, 32751
        • Florida Clinical Research Center, LLC
      • Miami, Florida, Verenigde Staten, 33126
        • Pharmax Research Clinic, Inc.
      • Miami, Florida, Verenigde Staten, 33144
        • L & L Research Choices
      • North Bay Village, Florida, Verenigde Staten, 33141
        • Bravo Health Care Center
      • Orange City, Florida, Verenigde Staten, 32763
        • Medical Research Group of Central Florida
      • Saint Petersburg, Florida, Verenigde Staten, 33716
        • Comprehensive Clinical Development Inc.
    • Idaho
      • Meridian, Idaho, Verenigde Staten, 83646
        • Solaris Clinical Research
      • Meridian, Idaho, Verenigde Staten, 83646
        • Barney Greenspan, Ph.D
    • Indiana
      • Evansville, Indiana, Verenigde Staten, 47715
        • Midwest Behavioral Health
      • Indianapolis, Indiana, Verenigde Staten, 46260
        • Goldpoint Clinical Research, LLC
      • Newburgh, Indiana, Verenigde Staten, 47630
        • Pedia Research, LLC
    • Kansas
      • Wichita, Kansas, Verenigde Staten, 67207
        • Heartland Research Associates, LLC
    • Kentucky
      • Bardstown, Kentucky, Verenigde Staten, 40004
        • Kentucky Pediatric/Adult Research
      • Lexington, Kentucky, Verenigde Staten, 40509
        • Central Kentucky Research Associates, Inc.
      • Owensboro, Kentucky, Verenigde Staten, 42301
        • Pedia Research, LLC
      • Owensboro, Kentucky, Verenigde Staten, 42303
        • Research Integrity, LLC
    • Louisiana
      • New Orleans, Louisiana, Verenigde Staten, 70114
        • Louisiana Research Associates, Inc
    • Massachusetts
      • Watertown, Massachusetts, Verenigde Staten, 02472
        • Adams Clinical Trials, LLC
    • Michigan
      • Rochester Hills, Michigan, Verenigde Staten, 48307
        • Rochester Center for Behavioral Medicine
    • Missouri
      • Kansas City, Missouri, Verenigde Staten, 64114
        • The Center for Pharmaceutical Research, P.C.
      • O'Fallon, Missouri, Verenigde Staten, 63368
        • Psychiatric Care & Research Center
      • Saint Louis, Missouri, Verenigde Staten, 63109
        • Mid-America Clinical Research, LLC
    • Nebraska
      • Lincoln, Nebraska, Verenigde Staten, 68526
        • Premier Psychiatric Research Institute, LLC
    • North Carolina
      • Raleigh, North Carolina, Verenigde Staten, 27612
        • Wake Research Associates
      • Raleigh, North Carolina, Verenigde Staten, 27612
        • Wake Internal Medicine Consultants, Inc
      • Wilmington, North Carolina, Verenigde Staten, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Canton, Ohio, Verenigde Staten, 44718
        • Neuro-Behavioral Clinical Research, Inc.
      • Toledo, Ohio, Verenigde Staten, 43623
        • Neurology & Neuroscience Center Of Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73116
        • Cutting Edge Research Group
    • South Carolina
      • Charleston, South Carolina, Verenigde Staten, 29425
        • Medical University of South Carolina
      • Mount Pleasant, South Carolina, Verenigde Staten, 29464
        • Coastal Carolina Research Center
    • Texas
      • Dallas, Texas, Verenigde Staten, 75231
        • FutureSearch Trials of Dallas, L.P.
      • DeSoto, Texas, Verenigde Staten, 75115
        • InSite Clinical Research, LLC
      • Lake Jackson, Texas, Verenigde Staten, 77566
        • R/D Clinical Research, Inc.
      • San Antonio, Texas, Verenigde Staten, 78229
        • Clinical Trials of Texas, Inc.
      • San Antonio, Texas, Verenigde Staten, 78230
        • Thomas Murray DeMoor, MD
    • Virginia
      • Richmond, Virginia, Verenigde Staten, 23235
        • Clinical Research Partners, LLC
    • Washington
      • Kirkland, Washington, Verenigde Staten, 98033
        • Eastside Therapeutic Resource
      • Richland, Washington, Verenigde Staten, 99352
        • Zain Research, Llc
    • Wisconsin
      • Middleton, Wisconsin, Verenigde Staten, 53562
        • Dean Foundation for Health Research and Education

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

12 jaar tot 19 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Healthy male and female subjects between the ages of 12 and 19, inclusive.
  • Subjects smoking at least an average of 5 cigarettes per day, motivated to stop smoking,
  • Subjects must have at least one prior failed attempt to quit smoking.

Exclusion Criteria:

  • Subjects with history, current diagnosis, or treatment of major depression disorder, anxiety disorders, panic disorder, hostility or aggression disorder, perceptual/thinking disturbances, mania, psychosis, bipolar disorder, personality disorder, eating disorder or severe emotional problems (in the past year).
  • Subjects with a prior suicide attempt: subjects hospitalized within the past 12 months due to suicidal ideation or suicidal behavior; subjects considered to have serious suicidal ideation or suicidal behavior in the past 12 months; active suicidal ideation or behavior identified at the screening or baseline visit.
  • Evidence of alcohol and substance abuse/dependence (other than nicotine) within 3 months prior to screening.

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: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Varenicline 1mg BID
Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Geneesmiddel: Varenicline 1mg BID
Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Experimenteel: Varenicline 0.5mg BID
Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Geneesmiddel: Varenicline 0.5mg BID
Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Placebo-vergelijker: Placebo
Oral placebo for twelve weeks,follow-up through Week 52
Geneesmiddel: Placebo
Oral placebo for twelve weeks,follow-up through Week 52

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
Tijdsspanne: Week 9 through Week 12
The percentage of participants who, at each visit from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and at each of these visits were confirmed to have quit based on urine cotinine less than 200 nanograms/milliliter (ng/mL).
Week 9 through Week 12

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
Tijdsspanne: Weeks 12, 24 and 52
The percentage of participants who reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) on the Nicotine Use Inventory in the 7 days prior to the study visits or telephone contacts at Week 12,24 and 52.
Weeks 12, 24 and 52
Daily Number of Cigarettes Smoked at Baseline
Tijdsspanne: Baseline
The average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.
Baseline
Change From Baseline in Daily Number of Cigarettes Smoked at Weeks 12, 24, and 52
Tijdsspanne: Baseline, Weeks 12, 24, and 52
The reduction in the number of the cigarettes smoked was calculated by subtracting the reported average number of cigarettes smoked per day in the past 7 days at Weeks 12, 24 and 52 from the average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.
Baseline, Weeks 12, 24, and 52
Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 24 and Week 52
Tijdsspanne: Week 9 through Week 24; Week 9 through Week 52
The percentage of participants who, at each visit from Week 9 to 52 (inclusive), reported no smoking and no use of other nicotine-containing products (Weeks 9-12) or tobacco products (Weeks 13-52) since the last study visit/last contact (on the Nicotine Use Inventory) and at any of the study visits were confirmed to have quit based on urine cotinine less than 200 ng/mL.
Week 9 through Week 24; Week 9 through Week 52

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Tijdsspanne: First dose up to last dose (up-to Week 12) plus 30 days
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious AEs and SAEs.
First dose up to last dose (up-to Week 12) plus 30 days
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Tijdsspanne: First dose up to last dose (up-to Week 12) plus 30 days
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to drug Varenicline was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious AEs and SAEs.
First dose up to last dose (up-to Week 12) plus 30 days
Number of Participants With Treatment-Emergent Neuropsychiatric Adverse Event Elicited by Neuropsychiatric Adverse Event Interview (NAEI)
Tijdsspanne: First dose up to last dose (up-to Week 12) plus 30 days
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE: AE causing: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent/significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Solicited AEs collected by semi-structured NAEI inquiring about AEs: depression, anxiety, delusions, hallucinations, paranoia, psychosis, mania, panic, agitation, dissociative states, feeling abnormal, hostility, aggression and homicidal ideation. If a participant had a positive response to any item on the NAEI, investigator determined if it met criteria AE criteria.
First dose up to last dose (up-to Week 12) plus 30 days
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Tijdsspanne: Screening, Baseline, Week 1 up to Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (last follow-up [FU])
The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories);was an interview-based instrument to systematically assess suicidal ideation and suicidal behavior.C-SSRS assessed whether participant experienced any of the following:completed suicide;suicide attempt(response of "Yes" on "actual attempt");preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior","aborted attempt" or "interrupted attempt"),suicidal ideation ("Yes" on "wish to be dead","non-specific active suicidal thoughts","active suicidal ideation with methods without intent to act or some intent to act,without specific plan or with specific plan and intent,any self-injurious behavior with no suicidal intent ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").Here,number of participants with positive response (response of "yes") to suicidal behavior or/and Ideation,any non-suicidal self-injurious behavior were reported.
Screening, Baseline, Week 1 up to Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (last follow-up [FU])
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety (HADS-A) Total Scores at Specified Time-points
Tijdsspanne: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
The HADS is a self-administered questionnaire measuring anxiety. Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A) consisted of 7 items that were assessed on a scale of 0 = no anxiety to 3 = severe feeling of anxiety. Total HADS-A subscale score range from 0 = no anxiety to 21 = severe anxiety; higher scores indicated more severe anxiety.
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores - Depression Total Score at Specified Time-Points
Tijdsspanne: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
Hospital Anxiety and Depression Scale Depression subscale (HADS-D) consists of 7 items that were assessed on a scale of 0 = no depression to 3 = severe feeling of depression. Total HADS-D subscale score range from 0 = no depression to 21 = severe feeling of depression; higher scores indicated a greater intensity of depression.
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
Number of Participants With Laboratory Abnormalities
Tijdsspanne: Baseline up to Week 12
Criteria for laboratory abnormalities: Lymphocytes Absolute (Abs), Lymphocytes percentage (%), Total Neutrophils (Abs), Neutrophils %: <0.8*LLN or >1.2*ULN; Basophils (Abs), Basophils %Eosinophils (Abs), Eosinophils %, Monocytes (Abs), Monocytes %:> 1.2*ULN; Total Bilirubin milligram per deciliter (mg/dl) >1.5*ULN; alanine aminotransferase: >3.0*ULN; Blood urea nitrogen, Creatinine: >1.3*ULN; Uric acid :> 1.2*ULN.
Baseline up to Week 12
Change From Baseline in Blood Pressure (BP) at Week 12
Tijdsspanne: Baseline, Week 12
Measurement of BP included supine and sitting systolic BP, standing systolic BP, supine and sitting diastolic BP and standing diastolic BP. Blood pressure was taken after participants rested in a sitting position for 5 minutes. BP was recorded after participants had been supine for approximately 5 minutes, and then orthostatic blood pressure was recorded immediately when the participant stood.
Baseline, Week 12
Change From Baseline in Pulse Rate at Week 12
Tijdsspanne: Baseline, Week 12
Measurement of pulse rate included supine, sitting and standing pulse rate. Pulse rate was taken after participants rested in a sitting position for 5 minutes. Pulse rate was recorded after participants had been supine for approximately 5 minutes and then immediately upon standing.
Baseline, Week 12

Medewerkers en onderzoekers

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

Sponsor

Pfizer

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 (Werkelijk)

1 april 2011

Primaire voltooiing (Werkelijk)

1 januari 2018

Studie voltooiing (Werkelijk)

1 januari 2018

Studieregistratiedata

Eerst ingediend

9 maart 2011

Eerst ingediend dat voldeed aan de QC-criteria

9 maart 2011

Eerst geplaatst (Schatting)

11 maart 2011

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 augustus 2018

Laatste update ingediend die voldeed aan QC-criteria

12 juli 2018

Laatst geverifieerd

1 juli 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • A3051073
  • CHANTIX (Andere identificatie: Alias Study Number)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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 .

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