Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia
9. april 2019 opdateret af: Otsuka Pharmaceutical Europe Ltd
Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia: an Observational, Non-interventional Study
This is an observational, non-interventional study that will include two cohorts of patients with schizophrenia who initiated maintenance treatment during a schizophrenia-related hospitalisation or during the immediate three months after hospital discharge: patients who initiated maintenance treatment with AOM and patients who initiated maintenance treatment with any daily oral atypical AP.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
This is an observational, non-interventional study that will include two cohorts of patients with schizophrenia who initiated maintenance treatment during a schizophrenia-related hospitalisation or during the immediate three months after hospital discharge: patients who initiated maintenance treatment with AOM and patients who initiated maintenance treatment with any daily oral atypical AP.
The date of maintenance treatment initiation will be considered the index date (see definition of maintenance treatment initiation in Section 3.1). Baseline data will be collected immediately after the inclusion of the patient in the study (including retrospective data from the index date to the date of informed consent and from the past 5 years). From the index date, each patient will be followed up until discontinuation of the maintenance treatment of interest and up to a maximum of 12 months. Especially after the implementation of the Global Amendment nº1, it is possible that the complete follow-up of the patient took place in the past (retrospective data), i.e. before the inclusion of the subject in the study. Data will be collected from the patient file and from information obtained during routine visits scheduled according to clinical practice.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
636
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Clamart, Frankrig
- Trukket tilbage
- H. Paul-Guiraud Clamart
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Jonzac, Frankrig
- Trukket tilbage
- CH Jonzac
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Laxou, Frankrig
- Trukket tilbage
- Centre Psychotherapique Nancy
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Limoges, Frankrig
- Trukket tilbage
- Centre Hospitalier Esquirol
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Montpellier, Frankrig
- Rekruttering
- CHS-La Colombière
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Nantes, Frankrig
- Trukket tilbage
- CHU Nantes Hospital Saint Jacques
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Nice, Frankrig
- Trukket tilbage
- CH Sainte Marie
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Nice, Frankrig
- Rekruttering
- CHU Pasteur
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Paris, Frankrig
- Rekruttering
- Hospital Maison Blanche XX Bichat
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Paris, Frankrig
- Trukket tilbage
- Hospital SAINTE ANNE
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Poitiers, Frankrig
- Rekruttering
- Centre Hospitalier Henri Laborit
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Rennes, Frankrig
- Rekruttering
- Centre Hospitalier Gillaume regnier-CHGR
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Saint Etienne, Frankrig
- Rekruttering
- CHU-Saint Etienne
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Saint-Egreve, Frankrig
- Trukket tilbage
- Centre Hospitalier Alpes Isère
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Toulon, Frankrig
- Trukket tilbage
- CHITS - Hôpital Chalucet
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Vesoul, Frankrig
- Trukket tilbage
- CHS St. Remy
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Ancona, Italien
- Rekruttering
- Ospedali Riuniti di Ancona
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Bari, Italien
- Rekruttering
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
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Camaiore, Italien
- Rekruttering
- Ospedale Versilia di Camaiore
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Genzano Di Roma, Italien
- Ikke rekrutterer endnu
- Cura Neuropsichiatria Villa Von Siebenthal
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Giulianova, Italien
- Rekruttering
- P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura
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Messina, Italien
- Rekruttering
- Mental Health Department (MDSM) ASP di Messina
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Milan, Italien
- Rekruttering
- Ospedale Niguarda
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Modena, Italien
- Rekruttering
- Dipartimento di Salute Mentale -ASL Modena
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Pesaro, Italien
- Rekruttering
- Centro Salute Mentale di Pesaro
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Roma, Italien
- Rekruttering
- Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria
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Roma, Italien
- Ikke rekrutterer endnu
- Fondazione PTV Policlinico Tor Vergara
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Rome, Italien
- Rekruttering
- Villa Maria Dia Hospital
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Salerno, Italien
- Rekruttering
- Unit Mental Health District Nº72- ASL Salerno
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Salerno, Italien
- Rekruttering
- Unita Operativa- Salute Mentale di Salerno
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Saluzzo, Italien
- Rekruttering
- Centro di Salute Mentale
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San Benedetto del Tronto, Italien
- Rekruttering
- Ospedale Madonna del Soccorso San Bendedetto del Tronto
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San Giorgio a Cremano, Italien
- Rekruttering
- Dipartimento di Salute Mentale- ASL Napoli
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Teramo, Italien
- Rekruttering
- ASL di Teramo
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Alcala de Henares, Spanien
- Trukket tilbage
- Hospital Príncipe de Asturias
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Barcelona, Spanien
- Rekruttering
- Hospital de Sant Pau
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Barcelona, Spanien
- Rekruttering
- Hospital del Mar
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Barcelona, Spanien
- Trukket tilbage
- Hospital Clínic de Barcelona
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Barcelona, Spanien
- Rekruttering
- IINA (Instituto Internacional de Neurociencias Aplicadas)
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Bilbao, Spanien
- Rekruttering
- Hospital Universitario de Cruces
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Girona, Spanien
- Rekruttering
- Hospital santa Caterina -IAS
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Granada, Spanien
- Rekruttering
- Hospital Campus de la Salud
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Huelva, Spanien
- Trukket tilbage
- Hospital Juan Ramón Jimenez
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Jerez de la Frontera, Spanien
- Rekruttering
- Hospital de Jerez
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L'Hospitalet de Llobregat, Spanien
- Rekruttering
- Hospital Universitari de Bellvitge
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Madrid, Spanien
- Rekruttering
- Hospital Universitario 12 de Octubre
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Madrid, Spanien
- Rekruttering
- Hospital Fundación Jiménez Díaz
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Madrid, Spanien
- Trukket tilbage
- Hospital Clinico San Carlos
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Malaga, Spanien
- Trukket tilbage
- Hermanas Hospitalarias de Málaga
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Murcia, Spanien
- Trukket tilbage
- Hospital General Universitario Morales Meseguer
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Palma, Spanien
- Rekruttering
- Hospital Son Espases
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Sabadell, Spanien
- Trukket tilbage
- Hospital Parc Tauli
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Sant Boi de Llobregat, Spanien
- Rekruttering
- Hospital Sant Joan de Déu de Sant Boi
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Santander, Spanien
- Rekruttering
- Hospital Marqués de Valdecilla
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Toledo, Spanien
- Rekruttering
- Hospital Provincial de Toledo
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Valencia, Spanien
- Trukket tilbage
- Hospital Clinico Universitario de Valencia
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Valencia, Spanien
- Trukket tilbage
- Hospital Universitari i Politecnic La Fe
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Vic, Spanien
- Rekruttering
- Hospital de Vic
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Vigo, Spanien
- Rekruttering
- Hospital Alvaro Cunqueiro
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Zamora, Spanien
- Trukket tilbage
- Hospital Provincial de Zamora
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Cadiz
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Algeciras, Cadiz, Spanien
- Rekruttering
- Hospital Punta de Europa
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Alzey, Tyskland
- Trukket tilbage
- Rheinhessen-Fachklinik Alzey
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Berlin, Tyskland
- Trukket tilbage
- Vivantes Klinikum
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Dusseldorf, Tyskland
- Trukket tilbage
- LVR- Klinikum Düsseldorf
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Homburg, Tyskland
- Trukket tilbage
- Universitätsklinikum des Saarlandes
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Magdeburg, Tyskland
- Trukket tilbage
- Universitätsklinikum Magdeburg
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Taufkirchen, Tyskland
- Trukket tilbage
- Kbo-Isar-Ampere-Klinikum Taufkirchen
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 35 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Eligible patients will include adult patients (≥18 years) with recent-onset (≤35 years old) schizophrenia who initiated maintenance treatment with AOM or an oral atypical AP during an inpatient stay due to an acute schizophrenia episode or during the immediate three months after hospital discharge and which treatment was initiated before the study start at the site and up to a maximum of 6 months after the launch of AOM in the country.
Prescription of the maintenance treatment had to be done in the usual manner in accordance with the terms of the marketing authorisation.
Beskrivelse
Inclusion Criteria:
- Adult patients between ≥18 and ≤35 years of age
- Diagnosis of schizophrenia confirmed by the current investigator.
Initiation of maintenance treatment with AOM (at least one injection) or with daily oral atypical AP before the study start at the site and up to a maximum of 6 months after the launch of AOM in the country, during an inpatient stay due to an acute schizophrenia episode or during the immediate three months after hospital discharge, and prescribed in the usual manner in accordance with the terms of the marketing authorisation.*
Patients treated in the daycare hospital will be considered:
- Eligible to be included, if the patient was admitted in the hospital (full time inpatient stay) for an acute psychotic episode and then discharged to a day care hospital in order to achieve stabilization and initiate maintenance antipsychotic treatment. The initiation of the maintenance antipsychotic treatment (index date) must occur before discharge from day care hospital or during the immediate following three months after discharge.
NOT eligible, if the patient was treated exclusively in the day care hospital since the first day (i.e. not spending any night at all in the hospital) as these patients are very likely to be subacutely psychotic.
- The date of initiation of maintenance therapy will be considered the index date. For AOM, it is the date of the first injection. For the oral AP, this date is defined by the physician when patients are believed to be stable enough to be considered "in maintenance treatment".
Willingness to participate in the study; subjects must give their written consent to participate unless: they have discontinued treatment or have finished the 12 months follow up period before study inclusion (retrospective assessment only) and a) written consent not required by local regulations, or b) it would take a non-reasonable effort† or c) the source patient is deceased or untraceable.
- A reasonable effort is defined as 3 contact attempts separated by 3 weeks. All efforts to obtain the informed consent, reasonable or not, shall be registered in the medical history of the patient to be used as documental source.
If allowable by local regulations/Ethics Committees, provision of oral (e.g., by phone) instead of written consent is also possible for patients with retrospective assessment only.
Exclusion Criteria:
- The patient has a psychiatric disorder other than schizophrenia which is established as the primary diagnosis
- Chronically hospitalized patients (defined as more than 3 months).
- Participation in an interventional clinical trial since AOM or daily oral atypical AP were initiated as maintenance treatment or within the previous 6 months to this initiation.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Aripiprazole Once Monthly (AOM)
Schizophrenia patients who initiated maintenance treatment with AOM during a schizophrenia-related hospitalisation or during the first three months after this hospitalisation.
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Daily oral atypical AP
Schizophrenia patients who initiated maintenance treatment with any daily oral atypical AP during a schizophrenia-related hospitalisation or during the first three months after this hospitalisation.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Time (days) to all-cause treatment discontinuation for AOM or daily oral atypical AP
Tidsramme: First 12 months after initiation of maintenance treatment
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Treatment discontinuation is defined as the interruption, replacement or addition of a new antipsychotic drug to the main antipsychotic initiated at index date (AOM or daily oral atypical AP).
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First 12 months after initiation of maintenance treatment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Treatment discontinuation rate (%) and description of the reasons for treatment discontinuation
Tidsramme: First 12 months after initiation of maintenance treatment
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To compare the treatment discontinuation rate and the reasons for this discontinuation during the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
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First 12 months after initiation of maintenance treatment
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Relapse rate (%) in the first 12 months after initiation of maintenance treatment
Tidsramme: First 12 months after initiation of maintenance treatment
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To compare the relapse rate in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
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First 12 months after initiation of maintenance treatment
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Change over time in CGI-S (score)
Tidsramme: From index date up to a maximun of 12 months
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To compare the evolution in disease severity according to Clinical Global Impression-Disease Severity (CGI-S) scale from initiation of maintenance treatment and up to the end of follow-up (12 months or up to discontinuation) between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP as maintenance treatment.
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From index date up to a maximun of 12 months
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Change over time in QLS-5 (score)
Tidsramme: From index date up to a maximun of 12 months
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To compare the clinical and functional outcomes according to the 5-item Quality of Life Scale for schizophrenia (QLS-5) from initiation of maintenance treatment and up to the end of follow-up (12 months or up to discontinuation) between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP as maintenance treatment.
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From index date up to a maximun of 12 months
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All-cause hospitalisation rate (%) in the first 12 months after initiation of maintenance treatment, time to first all-cause hospitalisation and length of hospitalisation(admission/discharge dates)
Tidsramme: From index date up to a maximun of 12 months
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To compare all cause hospitalisations in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
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From index date up to a maximun of 12 months
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Mental health-related hospitalisation rate (%) in the first 12 months after initiation of maintenance treatment, time to first mental health-related hospitalisation and length of mental-health related hospitalisation (admission/discharge dates)
Tidsramme: From index date up to a maximun of 12 months
|
To compare mental health-related hospitalisations in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
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From index date up to a maximun of 12 months
|
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Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures)
Tidsramme: From index date up to a maximun of 12 months
|
To compare the health resource use related to schizophrenia in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
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From index date up to a maximun of 12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
13. juli 2017
Primær færdiggørelse (Forventet)
31. januar 2020
Studieafslutning (Forventet)
31. januar 2020
Datoer for studieregistrering
Først indsendt
21. april 2017
Først indsendt, der opfyldte QC-kriterier
21. april 2017
Først opslået (Faktiske)
26. april 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. april 2019
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 031-303-00136
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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Ingen
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