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Special Survey on Parkinson's Disease (PD) Patients Without Concomitant Use of L-Dopa

28. maj 2014 opdateret af: Boehringer Ingelheim

Pramipexole Special Survey on Patients Without Concomitant Use of L-Dopa

The survey is conducted to collect safety and effectiveness information in Parkinson's Disease patients treated with Pramipexole without concomitant L-Dopa supplementation in the daily clinical settings in Japan.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

416

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Japan
      • Akita, Japan
        • Boehringer Ingelheim Investigational Site 11
      • Anan, Japan
        • Boehringer Ingelheim Investigational Site 95
      • Asahikawa, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Asahikawa, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Chiba, Japan
        • Boehringer Ingelheim Investigational Site 26
      • Chiba, Japan
        • Boehringer Ingelheim Investigational Site 27
      • Fuji, Japan
        • Boehringer Ingelheim Investigational Site 60
      • Fujisawa, Japan
        • Boehringer Ingelheim Investigational Site 49
      • Fukaya, Japan
        • Boehringer Ingelheim Investigational Site 25
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site 103
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site 104
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site 105
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site 106
      • Gifu, Japan
        • Boehringer Ingelheim Investigational Site 56
      • Habikino, Japan
        • Boehringer Ingelheim Investigational Site 80
      • Hakodate, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Hamamatsu, Japan
        • Boehringer Ingelheim Investigational Site 59
      • Handa, Japan
        • Boehringer Ingelheim Investigational Site 64
      • Himeji, Japan
        • Boehringer Ingelheim Investigational Site 82
      • Hirakata, Japan
        • Boehringer Ingelheim Investigational Site 76
      • Hiroshima, Japan
        • Boehringer Ingelheim Investigational Site 86
      • Hiroshima, Japan
        • Boehringer Ingelheim Investigational Site 87
      • Ichinoseki, Japan
        • Boehringer Ingelheim Investigational Site 8
      • Kagoshima, Japan
        • Boehringer Ingelheim Investigational Site 118
      • Kamisu, Japan
        • Boehringer Ingelheim Investigational Site 15
      • Kashiwazaki, Japan
        • Boehringer Ingelheim Investigational Site 50
      • Kasuga, Japan
        • Boehringer Ingelheim Investigational Site 107
      • Kawagoe, Japan
        • Boehringer Ingelheim Investigational Site 24
      • Kawasaki, Japan
        • Boehringer Ingelheim Investigational Site 46
      • Kawatana, Japan
        • Boehringer Ingelheim Investigational Site 111
      • Kawatana, Japan
        • Boehringer Ingelheim Investigational Site 112
      • Kitakyushu, Japan
        • Boehringer Ingelheim Investigational Site 99
      • Kiyotake, Japan
        • Boehringer Ingelheim Investigational Site 117
      • Kobe, Japan
        • Boehringer Ingelheim Investigational Site 83
      • Koga, Japan
        • Boehringer Ingelheim Investigational Site 67
      • Konan, Japan
        • Boehringer Ingelheim Investigational Site 63
      • Koriyama, Japan
        • Boehringer Ingelheim Investigational Site 12
      • Koriyama, Japan
        • Boehringer Ingelheim Investigational Site 13
      • Koshiagya, Japan
        • Boehringer Ingelheim Investigational Site 21
      • Kurume, Japan
        • Boehringer Ingelheim Investigational Site 100
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 68
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 69
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 70
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 71
      • Maebashi, Japan
        • Boehringer Ingelheim Investigational Site 19
      • Maebashi, Japan
        • Boehringer Ingelheim Investigational Site 20
      • Matsumoto, Japan
        • Boehringer Ingelheim Investigational Site 55
      • Mihara, Japan
        • Boehringer Ingelheim Investigational Site 88
      • Minobu, Japan
        • Boehringer Ingelheim Investigational Site 54
      • Miyakonojo, Japan
        • Boehringer Ingelheim Investigational Site 116
      • Miyazaki, Japan
        • Boehringer Ingelheim Investigational Site 114
      • Miyazaki, Japan
        • Boehringer Ingelheim Investigational Site 115
      • Moriguchi, Japan
        • Boehringer Ingelheim Investigational Site 77
      • Morioka, Japan
        • Boehringer Ingelheim Investigational Site 9
      • Moroyama, Japan
        • Boehringer Ingelheim Investigational Site 23
      • Muroran, Japan
        • Boehringer Ingelheim Investigational Site 4
      • Nagaoka, Japan
        • Boehringer Ingelheim Investigational Site 51
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site 61
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site 62
      • Nangoku, Japan
        • Boehringer Ingelheim Investigational Site 97
      • Naoetsu, Japan
        • Boehringer Ingelheim Investigational Site 102
      • Narita, Japan
        • Boehringer Ingelheim Investigational Site 28
      • Naruto, Japan
        • Boehringer Ingelheim Investigational Site 93
      • Nikko, Japan
        • Boehringer Ingelheim Investigational Site 17
      • Nishihara, Japan
        • Boehringer Ingelheim Investigational Site 119
      • Nishinomiya, Japan
        • Boehringer Ingelheim Investigational Site 81
      • Okawa, Japan
        • Boehringer Ingelheim Investigational Site 98
      • Osaka, Japan
        • Boehringer Ingelheim Investigational Site 72
      • Osakasayama, Japan
        • Boehringer Ingelheim Investigational Site 78
      • Otsu, Japan
        • Boehringer Ingelheim Investigational Site 66
      • Saga, Japan
        • Boehringer Ingelheim Investigational Site 108
      • Sagamihara, Japan
        • Boehringer Ingelheim Investigational Site 45
      • Saitama, Japan
        • Boehringer Ingelheim Investigational Site 22
      • Sakai, Japan
        • Boehringer Ingelheim Investigational Site 79
      • Sanjo, Japan
        • Boehringer Ingelheim Investigational Site 52
      • Sanyoonoda, Japan
        • Boehringer Ingelheim Investigational Site 90
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 5
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 6
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 7
      • Sasebo, Japan
        • Boehringer Ingelheim Investigational Site 110
      • Sendai, Japan
        • Boehringer Ingelheim Investigational Site 10
      • Shimonoseki, Japan
        • Boehringer Ingelheim Investigational Site 91
      • Shimotsuke, Japan
        • Boehringer Ingelheim Investigational Site 18
      • Shingu, Japan
        • Boehringer Ingelheim Investigational Site 85
      • Shizuoka, Japan
        • Boehringer Ingelheim Investigational Site 57
      • Shizuoka, Japan
        • Boehringer Ingelheim Investigational Site 58
      • Suita, Japan
        • Boehringer Ingelheim Investigational Site 73
      • Tagawa, Japan
        • Boehringer Ingelheim Investigational Site 101
      • Takamatsu, Japan
        • Boehringer Ingelheim Investigational Site 96
      • Takatsuki, Japan
        • Boehringer Ingelheim Investigational Site 74
      • Takatsuki, Japan
        • Boehringer Ingelheim Investigational Site 75
      • Togitsu, Japan
        • Boehringer Ingelheim Investigational Site 109
      • Tokushima, Japan
        • Boehringer Ingelheim Investigational Site 92
      • Tokyo Adachi-ku, Japan
        • Boehringer Ingelheim Investigational Site 30
      • Tokyo Arakawa-ku, Japan
        • Boehringer Ingelheim Investigational Site 31
      • Tokyo Bunkyo-ku, Japan
        • Boehringer Ingelheim Investigational Site 40
      • Tokyo Bunkyo-ku, Japan
        • Boehringer Ingelheim Investigational Site 41
      • Tokyo Bunkyo-ku, Japan
        • Boehringer Ingelheim Investigational Site 42
      • Tokyo Chiyoda-ku, Japan
        • Boehringer Ingelheim Investigational Site 38
      • Tokyo Itabashi-ku, Japan
        • Boehringer Ingelheim Investigational Site 32
      • Tokyo Itabashi-ku, Japan
        • Boehringer Ingelheim Investigational Site 33
      • Tokyo Meguro-ku, Japan
        • Boehringer Ingelheim Investigational Site 43
      • Tokyo Nakano-ku, Japan
        • Boehringer Ingelheim Investigational Site 39
      • Tokyo Ota-ku, Japan
        • Boehringer Ingelheim Investigational Site 34
      • Tokyo Ota-ku, Japan
        • Boehringer Ingelheim Investigational Site 35
      • Tokyo Shinjuku-ku, Japan
        • Boehringer Ingelheim Investigational Site 36
      • Tokyo Shinjuku-ku, Japan
        • Boehringer Ingelheim Investigational Site 37
      • Tokyo Toshima-ku, Japan
        • Boehringer Ingelheim Investigational Site 44
      • Tomiai, Japan
        • Boehringer Ingelheim Investigational Site 113
      • Toride, Japan
        • Boehringer Ingelheim Investigational Site 14
      • Tsu, Japan
        • Boehringer Ingelheim Investigational Site 65
      • Tsukuba, Japan
        • Boehringer Ingelheim Investigational Site 16
      • Uchinada, Japan
        • Boehringer Ingelheim Investigational Site 53
      • Urayasu, Japan
        • Boehringer Ingelheim Investigational Site 29
      • Wakayama, Japan
        • Boehringer Ingelheim Investigational Site 84
      • Yamaguchi, Japan
        • Boehringer Ingelheim Investigational Site 89
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 47
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 48
      • Yoshinogawa, Japan
        • Boehringer Ingelheim Investigational Site 94

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Parkinson's disease patients in daily clinical settings

Beskrivelse

Inclusion Criteria:

Patients with Parkinson's disease who do not receive L-Dopa supplementation

Exclusion Criteria:

Patients should have been treated according to the Japanese insert slip

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Tidsramme: during 36 months
The aim of this Post Marketing Surveillance (PMS) was to obtain safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years.
during 36 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical Global Impression of Improvement
Tidsramme: after 36 months treatment
Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
after 36 months treatment
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Tidsramme: Baseline and at 36 months (or at the time of discontinuation)
Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.
Baseline and at 36 months (or at the time of discontinuation)
Change From Baseline in Modified Hoehn & Yahr Rating Scale
Tidsramme: Baseline and at 36 months (or at the time of discontinuation)
A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).
Baseline and at 36 months (or at the time of discontinuation)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

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.

Hjælpsomme links

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

1. februar 2004

Primær færdiggørelse (Faktiske)

1. september 2009

Datoer for studieregistrering

Først indsendt

31. januar 2008

Først indsendt, der opfyldte QC-kriterier

12. februar 2008

Først opslået (Skøn)

13. februar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 248.549

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Parkinsons sygdom

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Colombia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner