Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Survey on PD Patients With Depressive Symptoms

1. august 2014 oppdatert av: 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

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

1089

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

PD patients with depressive symptoms

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinical Global Impression of Improvement
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2007

Primær fullføring (Faktiske)

1. august 2009

Datoer for studieregistrering

Først innsendt

31. januar 2008

Først innsendt som oppfylte QC-kriteriene

12. februar 2008

Først lagt ut (Anslag)

13. februar 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. august 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. august 2014

Sist bekreftet

1. august 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 248.635

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere