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

28 augusti 2014 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Observationell

Inskrivning (Faktisk)

571

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

15 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

500

Beskrivning

Inclusion criteria:

Patient with Restless Legs Syndrome

Exclusion criteria:

None

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Patient with Restless Legs Syndrome

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of Drug-related Adverse Events
Tidsram: 12 Months
Number of patients with drug-related adverse events
12 Months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Boehringer Ingelheim

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2010

Primärt slutförande (Faktisk)

1 augusti 2013

Avslutad studie (Faktisk)

1 augusti 2013

Studieregistreringsdatum

Först inskickad

2 augusti 2010

Först inskickad som uppfyllde QC-kriterierna

2 augusti 2010

Första postat (Uppskatta)

3 augusti 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

29 augusti 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 augusti 2014

Senast verifierad

1 augusti 2014

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 248.678

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera