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Survey on PD Patients With Depressive Symptoms

1 augustus 2014 bijgewerkt door: Boehringer Ingelheim

BI_Sifrol Tablets Special Drug Use Surveillance(Survey on the Safety and Efficacy in Parkinson's Disease Patients With Depressive Symptoms)

The primary objective of this investigation is to conduct a 12-week prospective survey in PD patients with depressive symptoms treated with BI Sifrol Tablets (hereinafter referred to as this drug) in the routine clinical settings to determine the following items related to the safety and efficacy.

i. Adverse drug reaction symptoms, incidence, and severity ii. Motor capacity during the investigation iii. Depressive symptoms during the investigation

Studie Overzicht

Toestand

Voltooid

Conditie

Studietype

Observationeel

Inschrijving (Werkelijk)

1089

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

  • Japan
      • Akashi, Japan
        • Boehringer Ingelheim Investigational Site
      • Akita, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Akita, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Asahikawa, Japan
        • Boehringer Ingelheim Investigational Site
      • Ashikaga, Japan
        • Boehringer Ingelheim Investigational Site
      • Awaji, Japan
        • Boehringer Ingelheim Investigational Site
      • Chitose, Japan
        • Boehringer Ingelheim Investigational Site
      • Chuo, Japan
        • Boehringer Ingelheim Investigational Site
      • Fuchu, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Fuchu, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Fuefuki, Japan
        • Boehringer Ingelheim Investigational Site
      • Fuehuki, Japan
        • Boehringer Ingelheim Investigational Site
      • Fujioka, Japan
        • Boehringer Ingelheim Investigational Site
      • Fujisaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Fujisawa, Japan
        • Boehringer Ingelheim Investigational Site
      • Fukaya, Japan
        • Boehringer Ingelheim Investigational Site
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site 4
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site 5
      • Fukushima, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Fukushima, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Funabashi, Japan
        • Boehringer Ingelheim Investigational Site
      • Gifu, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Gifu, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Habikino, Japan
        • Boehringer Ingelheim Investigational Site
      • Hachioji, Japan
        • Boehringer Ingelheim Investigational Site
      • Hamamatsu, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Hamamatsu, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Hamamatsu, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Hamamatsu, Japan
        • Boehringer Ingelheim Investigational Site 4
      • Hamamatsu, Japan
        • Boehringer Ingelheim Investigational Site 5
      • Hanamaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Hayashima, Japan
        • Boehringer Ingelheim Investigational Site
      • Higashiosaka, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Higashiosaka, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Himeji, Japan
        • Boehringer Ingelheim Investigational Site
      • Hirakata, Japan
        • Boehringer Ingelheim Investigational Site
      • Hirishima, Japan
        • Boehringer Ingelheim Investigational Site
      • Hirosaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Ibaragi, Japan
        • Boehringer Ingelheim Investigational Site
      • Iizuka, Japan
        • Boehringer Ingelheim Investigational Site
      • Inag, Japan
        • Boehringer Ingelheim Investigational Site
      • Irima, Japan
        • Boehringer Ingelheim Investigational Site
      • Isahaya, Japan
        • Boehringer Ingelheim Investigational Site
      • Iwaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Iwamizawa, Japan
        • Boehringer Ingelheim Investigational Site
      • Iwata, Japan
        • Boehringer Ingelheim Investigational Site
      • Jyoetsu, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Jyoetsu, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Jyoyo, Japan
        • Boehringer Ingelheim Investigational Site
      • Kagoshima, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Kagoshima, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Kagoshima, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Kahoku, Japan
        • Boehringer Ingelheim Investigational Site
      • Kamakura, Japan
        • Boehringer Ingelheim Investigational Site
      • Kanazawa, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Kanazawa, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Kanoya, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Kanoya, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Kashihara, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Kashihara, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Kasuga, Japan
        • Boehringer Ingelheim Investigational Site
      • Kawagchi, Japan
        • Boehringer Ingelheim Investigational Site
      • Kawaguchi, Japan
        • Boehringer Ingelheim Investigational Site
      • Kawasaki, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Kawasaki, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Kitakami, Japan
        • Boehringer Ingelheim Investigational Site
      • Kiyose, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Kiyose, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Kodaira, Japan
        • Boehringer Ingelheim Investigational Site
      • Kofu, Japan
        • Boehringer Ingelheim Investigational Site
      • Koga, Japan
        • Boehringer Ingelheim Investigational Site
      • Komae, Japan
        • Boehringer Ingelheim Investigational Site
      • Komatsu, Japan
        • Boehringer Ingelheim Investigational Site
      • Komatsushima, Japan
        • Boehringer Ingelheim Investigational Site
      • Koriyama, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Koriyama, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Koshigaya, Japan
        • Boehringer Ingelheim Investigational Site
      • Kumamoto, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Kumamoto, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Kumamoto, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Kure, Japan
        • Boehringer Ingelheim Investigational Site
      • Kusatsu, Japan
        • Boehringer Ingelheim Investigational Site
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 4
      • Maebashi, Japan
        • Boehringer Ingelheim Investigational Site
      • Matsudo, Japan
        • Boehringer Ingelheim Investigational Site
      • Matsumoto, Japan
        • Boehringer Ingelheim Investigational Site
      • Mibu, Japan
        • Boehringer Ingelheim Investigational Site
      • Mihara, Japan
        • Boehringer Ingelheim Investigational Site
      • Mihoro, Japan
        • Boehringer Ingelheim Investigational Site
      • Miriyama, Japan
        • Boehringer Ingelheim Investigational Site
      • Misato, Japan
        • Boehringer Ingelheim Investigational Site
      • Miyako, Japan
        • Boehringer Ingelheim Investigational Site
      • Miyazaki, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Miyazaki, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Moriguchi, Japan
        • Boehringer Ingelheim Investigational Site
      • Morioka, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Morioka, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Moriya, Japan
        • Boehringer Ingelheim Investigational Site
      • Musashino, Japan
        • Boehringer Ingelheim Investigational Site
      • Nagano, Japan
        • Boehringer Ingelheim Investigational Site
      • Nagaoka, Japan
        • Boehringer Ingelheim Investigational Site
      • Nagaokakyo, Japan
        • Boehringer Ingelheim Investigational Site
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site 4
      • Nara, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Nara, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Narashino, Japan
        • Boehringer Ingelheim Investigational Site
      • Narita, Japan
        • Boehringer Ingelheim Investigational Site
      • Naruto, Japan
        • Boehringer Ingelheim Investigational Site
      • Nasushiobara, Japan
        • Boehringer Ingelheim Investigational Site
      • Nichinan, Japan
        • Boehringer Ingelheim Investigational Site
      • Ninohe, Japan
        • Boehringer Ingelheim Investigational Site
      • Nishinomiya, Japan
        • Boehringer Ingelheim Investigational Site
      • Nishitokyo, Japan
        • Boehringer Ingelheim Investigational Site
      • Ogaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Oiso, Japan
        • Boehringer Ingelheim Investigational Site
      • Oita, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Oita, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Oita, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Okaya, Japan
        • Boehringer Ingelheim Investigational Site
      • Okayama, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Okayama, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Okazaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Okinawa, Japan
        • Boehringer Ingelheim Investigational Site
      • Omura, Japan
        • Boehringer Ingelheim Investigational Site
      • Omuta, Japan
        • Boehringer Ingelheim Investigational Site
      • Onojyo, Japan
        • Boehringer Ingelheim Investigational Site
      • Osaka, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Osaka, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Osaka, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Osaka, Japan
        • Boehringer Ingelheim Investigational Site 4
      • Osaka, Japan
        • Boehringer Ingelheim Investigational Site 5
      • Osaka, Japan
        • Boehringer Ingelheim Investigational Site 6
      • Ota, Japan
        • Boehringer Ingelheim Investigational Site
      • Otake, Japan
        • Boehringer Ingelheim Investigational Site
      • Otsu, Japan
        • Boehringer Ingelheim Investigational Site
      • Ryugasaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Saeki, Japan
        • Boehringer Ingelheim Investigational Site
      • Saga, Japan
        • Boehringer Ingelheim Investigational Site
      • Sagamihara, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Sagamihara, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Sagamihara, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Saijyo, Japan
        • Boehringer Ingelheim Investigational Site
      • Saitama, Japan
        • Boehringer Ingelheim Investigational Site
      • Sakai, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Sakai, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 4
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 5
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 6
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 8
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 9
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 7
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Sekigahara, Japan
        • Boehringer Ingelheim Investigational Site
      • Sendai, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Sendai, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Shimoda, Japan
        • Boehringer Ingelheim Investigational Site
      • Shimotsuke, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Shimotsuke, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Shinngu, Japan
        • Boehringer Ingelheim Investigational Site
      • Shiroishi, Japan
        • Boehringer Ingelheim Investigational Site
      • Shizuoka, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Shizuoka, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Showajima, Japan
        • Boehringer Ingelheim Investigational Site
      • Suita, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Suita, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Susono, Japan
        • Boehringer Ingelheim Investigational Site
      • Suzuka, Japan
        • Boehringer Ingelheim Investigational Site
      • Takaoka, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Takaoka, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Takatsuki, Japan
        • Boehringer Ingelheim Investigational Site
      • Tarimizu, Japan
        • Boehringer Ingelheim Investigational Site
      • Togitsu, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokoname, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokushima, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Arakawa-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Bunkyo-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Chuo-ku, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Tokyo Chuo-ku, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Tokyo Daito-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Koto-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Meguro-ku, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Tokyo Meguro-ku, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Tokyo Minato-ku, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Tokyo Minato-ku, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Tokyo Minato-ku, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Tokyo Nakano-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Nerima-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Ota-ku, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Tokyo Ota-ku, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Tokyo Setagaya, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Setagaya-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Shibuya-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Shinagawa-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Shinjyuku-ku, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Tokyo Shinjyuku-ku, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Tokyo Shinjyuku-ku, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Tokyo Sibuya-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Toshima-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo-Edogawa-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo-Itabashi-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Toride, Japan
        • Boehringer Ingelheim Investigational Site
      • Tosu, Japan
        • Boehringer Ingelheim Investigational Site
      • Toyama, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Toyama, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Toyama, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Toyohashi, Japan
        • Boehringer Ingelheim Investigational Site
      • Toyokawa, Japan
        • Boehringer Ingelheim Investigational Site
      • Toyonaka, Japan
        • Boehringer Ingelheim Investigational Site
      • Ube, Japan
        • Boehringer Ingelheim Investigational Site
      • Uchinada, Japan
        • Boehringer Ingelheim Investigational Site
      • Ueda, Japan
        • Boehringer Ingelheim Investigational Site
      • Ushiku, Japan
        • Boehringer Ingelheim Investigational Site
      • Utsunomiya, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Utsunomiya, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Wakayama, Japan
        • Boehringer Ingelheim Investigational Site
      • Yachiyo, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Yachiyo, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Yachiyo, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Yamanashi, Japan
        • Boehringer Ingelheim Investigational Site
      • Yanago, Japan
        • Boehringer Ingelheim Investigational Site
      • Yoichi, Japan
        • Boehringer Ingelheim Investigational Site
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 4
      • Yokosuka, Japan
        • Boehringer Ingelheim Investigational Site
      • Yoshinogawa, Japan
        • Boehringer Ingelheim Investigational Site

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

20 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

PD patients with depressive symptoms

Beschrijving

Inclusion criteria:

**PD patients with depressive symptoms Patients who have not received pramipexole hydrochloride hydrate preparations within 1 month before survey entrance.

Exclusion criteria:

  • PD patients with the past history of suicidal attempt, suicidal ideation or tendency
  • PD patients with suicidal ideation
  • PD patients with the past history of suicidal tendency

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

Cohorten en interventies

Groep / Cohort
BI-Sifrol® Tablets (Pramipexole)
BI-Sifrol® Tablets, pramipexole dose: 0.125 mg, 0.5 mg, No reference therapy

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
Tijdsspanne: for 12 weeks
The aim of this Post Marketing Surveillance (PMS) was to obtain safety data with treatment of pramipexole in Parkinson's disease patients with depressive symptoms. The percentage of participants with adverse events, adverse drug reactions, and serious adverse events are presented.
for 12 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinical Global Impression of Improvement
Tijdsspanne: for 12 weeks after initiation of the treatment
Investigators evaluation of the Parkinson's disease (PD) symptoms on the Clinical Global Impression (CGI) with 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
for 12 weeks after initiation of the treatment
Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Tijdsspanne: Baseline and after 12 weeks (or at the time of discontinuation)
Part III of the UPDRS contains the clinician-scored motor evaluation, and includes 14 individual items each scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. A negative change in the Part III total score indicates improvement.
Baseline and after 12 weeks (or at the time of discontinuation)
Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score
Tijdsspanne: Baseline and after 12 weeks (or at the time of discontinuation)
The degree of severity in depressive state are scored between 0-63 in BDI. A decrease in the score means improvement.
Baseline and after 12 weeks (or at the time of discontinuation)
Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score
Tijdsspanne: Baseline and after 12 weeks (or at the time of discontinuation)
Unified Parkinson's Disease Rating Scale Part I Item 3 assesses the participant for symptoms of depression. Item 3 scores range from 0 (None) to 4 (Sustained depression with suicidal thoughts or intent). A higher score indicates more severe depression symptoms. A negative change in the item 3 score indicates improvement.
Baseline and after 12 weeks (or at the time of discontinuation)
Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale
Tijdsspanne: After 12 weeks or at the time of discontinuation
This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden). A negative change in the Yahr rating scale indicates improvement.
After 12 weeks or at the time of discontinuation

Medewerkers en onderzoekers

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

Sponsor

Boehringer Ingelheim

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.

Nuttige links

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 januari 2007

Primaire voltooiing (Werkelijk)

1 augustus 2009

Studieregistratiedata

Eerst ingediend

31 januari 2008

Eerst ingediend dat voldeed aan de QC-criteria

12 februari 2008

Eerst geplaatst (Schatting)

13 februari 2008

Updates van studierecords

Laatste update geplaatst (Schatting)

6 augustus 2014

Laatste update ingediend die voldeed aan QC-criteria

1 augustus 2014

Laatst geverifieerd

1 augustus 2014

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 248.635

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