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Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome

28. august 2014 opdateret af: Boehringer Ingelheim
The survey is conducted to investigate the safety and efficacy of long-term use of BI-Sifrol Tablets in Restless Legs Syndrome (RLS) patients with or without renal dysfunction in routine medical practice.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

571

Kontakter og lokationer

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

Studiesteder

  • Japan
      • Akashi, Japan
        • Boehringer Ingelheim Investigational Site 119
      • Akishima, Japan
        • Boehringer Ingelheim Investigational Site 52
      • Akita, Japan
        • Boehringer Ingelheim Investigational Site 16
      • Ami-machi, Japan
        • Boehringer Ingelheim Investigational Site 22
      • Asahi, Japan
        • Boehringer Ingelheim Investigational Site 36
      • Asahikawa, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Chiba, Japan
        • Boehringer Ingelheim Investigational Site 40
      • Chofu, Japan
        • Boehringer Ingelheim Investigational Site 158
      • Chuo, Japan
        • Boehringer Ingelheim Investigational Site 78
      • Fujisawa, Japan
        • Boehringer Ingelheim Investigational Site 66
      • Fukagawa, Japan
        • Boehringer Ingelheim Investigational Site 7
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site 144
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site 146
      • Fukushima, Japan
        • Boehringer Ingelheim Investigational Site 19
      • Fukuyama, Japan
        • Boehringer Ingelheim Investigational Site 132
      • Gifu, Japan
        • Boehringer Ingelheim Investigational Site 82
      • Hamamatsu, Japan
        • Boehringer Ingelheim Investigational Site 83
      • Hatchioji, Japan
        • Boehringer Ingelheim Investigational Site 56
      • Hayashima-machi, Japan
        • Boehringer Ingelheim Investigational Site 129
      • Himeji, Japan
        • Boehringer Ingelheim Investigational Site 123
      • Hirakata, Japan
        • Boehringer Ingelheim Investigational Site 111
      • Hiroshima, Japan
        • Boehringer Ingelheim Investigational Site 133
      • Honjo, Japan
        • Boehringer Ingelheim Investigational Site 30
      • Ichihara, Japan
        • Boehringer Ingelheim Investigational Site 38
      • Ichikawa, Japan
        • Boehringer Ingelheim Investigational Site 37
      • Ichikawasango-machi, Japan
        • Boehringer Ingelheim Investigational Site 79
      • Ikeda, Japan
        • Boehringer Ingelheim Investigational Site 117
      • Isahaya, Japan
        • Boehringer Ingelheim Investigational Site 149
      • Itami, Japan
        • Boehringer Ingelheim Investigational Site 118
      • Iwamizawa, Japan
        • Boehringer Ingelheim Investigational Site 10
      • Izumo, Japan
        • Boehringer Ingelheim Investigational Site 127
      • Kagoshima, Japan
        • Boehringer Ingelheim Investigational Site 154
      • Kagoshima, Japan
        • Boehringer Ingelheim Investigational Site 155
      • Kanazawa, Japan
        • Boehringer Ingelheim Investigational Site 74
      • Kanazawa, Japan
        • Boehringer Ingelheim Investigational Site 76
      • Katou, Japan
        • Boehringer Ingelheim Investigational Site 120
      • Kawai-machi, Japan
        • Boehringer Ingelheim Investigational Site 124
      • Kawasaki, Japan
        • Boehringer Ingelheim Investigational Site 60
      • Kawasaki, Japan
        • Boehringer Ingelheim Investigational Site 63
      • Keroyama-machi, Japan
        • Boehringer Ingelheim Investigational Site 31
      • Kitakyuushu, Japan
        • Boehringer Ingelheim Investigational Site 145
      • Kobe, Japan
        • Boehringer Ingelheim Investigational Site 122
      • Kodaira, Japan
        • Boehringer Ingelheim Investigational Site 46
      • Kodaira, Japan
        • Boehringer Ingelheim Investigational Site 50
      • Koshigaya, Japan
        • Boehringer Ingelheim Investigational Site 32
      • Kumamoto, Japan
        • Boehringer Ingelheim Investigational Site 150
      • Kumamoto, Japan
        • Boehringer Ingelheim Investigational Site 151
      • Kurume, Japan
        • Boehringer Ingelheim Investigational Site 143
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 102
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 103
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 98
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 99
      • Maizuru, Japan
        • Boehringer Ingelheim Investigational Site 100
      • Mat?uyama, Japan
        • Boehringer Ingelheim Investigational Site 142
      • Matsumoto, Japan
        • Boehringer Ingelheim Investigational Site 80
      • Matsumoto, Japan
        • Boehringer Ingelheim Investigational Site 81
      • Mibu-machi, Japan
        • Boehringer Ingelheim Investigational Site 28
      • Miki-machi, Japan
        • Boehringer Ingelheim Investigational Site 138
      • Minoo, Japan
        • Boehringer Ingelheim Investigational Site 115
      • Mitaka, Japan
        • Boehringer Ingelheim Investigational Site 47
      • Miyazaki, Japan
        • Boehringer Ingelheim Investigational Site 153
      • Miyoshi, Japan
        • Boehringer Ingelheim Investigational Site 134
      • Moriguchi, Japan
        • Boehringer Ingelheim Investigational Site 112
      • Morioka, Japan
        • Boehringer Ingelheim Investigational Site 13
      • Muroran, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Nagakute-machi, Japan
        • Boehringer Ingelheim Investigational Site 88
      • Nagaokakyo, Japan
        • Boehringer Ingelheim Investigational Site 101
      • Nagareyama, Japan
        • Boehringer Ingelheim Investigational Site 41
      • Nagasaki, Japan
        • Boehringer Ingelheim Investigational Site 148
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site 85
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site 86
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site 87
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site 92
      • Nigata, Japan
        • Boehringer Ingelheim Investigational Site 68
      • Nigata, Japan
        • Boehringer Ingelheim Investigational Site 69
      • Nigata, Japan
        • Boehringer Ingelheim Investigational Site 70
      • Nigata, Japan
        • Boehringer Ingelheim Investigational Site 71
      • Niihama, Japan
        • Boehringer Ingelheim Investigational Site 139
      • Niihama, Japan
        • Boehringer Ingelheim Investigational Site 141
      • Ninohe, Japan
        • Boehringer Ingelheim Investigational Site 11
      • Nishinomiya, Japan
        • Boehringer Ingelheim Investigational Site 121
      • Nishitokyo, Japan
        • Boehringer Ingelheim Investigational Site 157
      • Odate, Japan
        • Boehringer Ingelheim Investigational Site 17
      • Oita, Japan
        • Boehringer Ingelheim Investigational Site 152
      • Okayama, Japan
        • Boehringer Ingelheim Investigational Site 130
      • Okayama, Japan
        • Boehringer Ingelheim Investigational Site 131
      • Okazaki, Japan
        • Boehringer Ingelheim Investigational Site 89
      • Osaka, Japan
        • Boehringer Ingelheim Investigational Site 104
      • Osaka, Japan
        • Boehringer Ingelheim Investigational Site 105
      • Osaka, Japan
        • Boehringer Ingelheim Investigational Site 106
      • Osakasayama, Japan
        • Boehringer Ingelheim Investigational Site 113
      • Ota, Japan
        • Boehringer Ingelheim Investigational Site 128
      • Otsu, Japan
        • Boehringer Ingelheim Investigational Site 97
      • Ozu, Japan
        • Boehringer Ingelheim Investigational Site 140
      • Ryugasaki, Japan
        • Boehringer Ingelheim Investigational Site 26
      • Saga, Japan
        • Boehringer Ingelheim Investigational Site 147
      • Sagamihara, Japan
        • Boehringer Ingelheim Investigational Site 64
      • Saitama, Japan
        • Boehringer Ingelheim Investigational Site 34
      • Sakai, Japan
        • Boehringer Ingelheim Investigational Site 107
      • Sakai, Japan
        • Boehringer Ingelheim Investigational Site 108
      • Sakura, Japan
        • Boehringer Ingelheim Investigational Site 39
      • 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
      • Sendai, Japan
        • Boehringer Ingelheim Investigational Site 14
      • Sendai, Japan
        • Boehringer Ingelheim Investigational Site 15
      • Shimotsuke, Japan
        • Boehringer Ingelheim Investigational Site 27
      • Shimotsuke, Japan
        • Boehringer Ingelheim Investigational Site 29
      • Shingu, Japan
        • Boehringer Ingelheim Investigational Site 125
      • Shizuoka, Japan
        • Boehringer Ingelheim Investigational Site 84
      • Suzuka, Japan
        • Boehringer Ingelheim Investigational Site 95
      • Suzuka, Japan
        • Boehringer Ingelheim Investigational Site 96
      • Takamatsu, Japan
        • Boehringer Ingelheim Investigational Site 137
      • Takatsuki, Japan
        • Boehringer Ingelheim Investigational Site 109
      • Takatsuki, Japan
        • Boehringer Ingelheim Investigational Site 110
      • Takizawa-mura, Japan
        • Boehringer Ingelheim Investigational Site 12
      • Tokorozawa, Japan
        • Boehringer Ingelheim Investigational Site 33
      • Tokyo Arakawa, Japan
        • Boehringer Ingelheim Investigational Site 42
      • Tokyo Chuo, Japan
        • Boehringer Ingelheim Investigational Site 53
      • Tokyo Itabashi, Japan
        • Boehringer Ingelheim Investigational Site 43
      • Tokyo Meguro, Japan
        • Boehringer Ingelheim Investigational Site 45
      • Tokyo Minato, Japan
        • Boehringer Ingelheim Investigational Site 54
      • Tokyo Nerima, Japan
        • Boehringer Ingelheim Investigational Site 49
      • Tokyo Nerima, Japan
        • Boehringer Ingelheim Investigational Site 55
      • Tokyo Ota, Japan
        • Boehringer Ingelheim Investigational Site 44
      • Tokyo Shibuya, Japan
        • Boehringer Ingelheim Investigational Site 51
      • Tokyo Shibuya, Japan
        • Boehringer Ingelheim Investigational Site 58
      • Tokyo Shinagawa, Japan
        • Boehringer Ingelheim Investigational Site 57
      • Tokyo Shinjyuku, Japan
        • Boehringer Ingelheim Investigational Site 48
      • Toride, Japan
        • Boehringer Ingelheim Investigational Site 21
      • Tottori, Japan
        • Boehringer Ingelheim Investigational Site 126
      • Toyama, Japan
        • Boehringer Ingelheim Investigational Site 72
      • Toyama, Japan
        • Boehringer Ingelheim Investigational Site 73
      • Toyohashi, Japan
        • Boehringer Ingelheim Investigational Site 90
      • Toyohashi, Japan
        • Boehringer Ingelheim Investigational Site 93
      • Toyokawa, Japan
        • Boehringer Ingelheim Investigational Site 91
      • Toyokawa, Japan
        • Boehringer Ingelheim Investigational Site 94
      • Toyonaka, Japan
        • Boehringer Ingelheim Investigational Site 114
      • Toyonaka, Japan
        • Boehringer Ingelheim Investigational Site 116
      • Tsuchiura, Japan
        • Boehringer Ingelheim Investigational Site 20
      • Tsukuba, Japan
        • Boehringer Ingelheim Investigational Site 24
      • Tsuruga, Japan
        • Boehringer Ingelheim Investigational Site 77
      • Tsurugashima, Japan
        • Boehringer Ingelheim Investigational Site 35
      • Urazoe, Japan
        • Boehringer Ingelheim Investigational Site 156
      • Ushiku, Japan
        • Boehringer Ingelheim Investigational Site 23
      • Ushiku, Japan
        • Boehringer Ingelheim Investigational Site 25
      • Utinada-machi, Japan
        • Boehringer Ingelheim Investigational Site 75
      • Yamagata, Japan
        • Boehringer Ingelheim Investigational Site 18
      • Yanai, Japan
        • Boehringer Ingelheim Investigational Site 135
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 59
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 61
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 62
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 65
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 67
      • Yokose-machi, Japan
        • Boehringer Ingelheim Investigational Site 159
      • Yoshinogawa, Japan
        • Boehringer Ingelheim Investigational Site 136

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

15 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

500

Beskrivelse

Inclusion criteria:

Patient with Restless Legs Syndrome

Exclusion criteria:

None

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
Patient with Restless Legs Syndrome

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Drug-related Adverse Events
Tidsramme: 12 Months
Number of patients with drug-related adverse events
12 Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS)
Tidsramme: after 12 months or at the end of observation
International Restless Legs Syndrome rating scale (IRLS): The IRLS rating scale is a selfrating scale used to evaluate the severity of RLS and the patients are requested to answer 10 questions on a scale of 0 to 4. Respective scores (0-4 points) for the 10 questions were added up to calculate the total score on the IRLS. Therefore the total score is 0-40. The lower values represent a better outcome.
after 12 months or at the end of observation

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. august 2010

Primær færdiggørelse (Faktiske)

1. august 2013

Studieafslutning (Faktiske)

1. august 2013

Datoer for studieregistrering

Først indsendt

2. august 2010

Først indsendt, der opfyldte QC-kriterier

2. august 2010

Først opslået (Skøn)

3. august 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. august 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. august 2014

Sidst verificeret

1. august 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 248.678

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 Restless Legs Syndrome

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Argentina

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner