Clinical trial NCT01174459: Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome
Official title: Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Restless Legs Syndrome
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-08-03
Enrollment: 571
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500

Brief summary: 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.


Eligibility criteria: Inclusion criteria:

Patient with Restless Legs Syndrome

Exclusion criteria:

None

Primary outcomes:
measure: Incidence of Drug-related Adverse Events
timeFrame: 12 Months
Secondary outcomes:
measure: Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS)
timeFrame: after 12 months or at the end of observation
Other outcomes:
Locations:
city: Akashi
country: Japan
facility: Boehringer Ingelheim Investigational Site 119
city: Akishima
country: Japan
facility: Boehringer Ingelheim Investigational Site 52
city: Akita
country: Japan
facility: Boehringer Ingelheim Investigational Site 16
city: Ami-machi
country: Japan
facility: Boehringer Ingelheim Investigational Site 22
city: Asahikawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Asahi
country: Japan
facility: Boehringer Ingelheim Investigational Site 36
city: Chiba
country: Japan
facility: Boehringer Ingelheim Investigational Site 40
city: Chofu
country: Japan
facility: Boehringer Ingelheim Investigational Site 158
city: Chuo
country: Japan
facility: Boehringer Ingelheim Investigational Site 78
city: Fujisawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 66
city: Fukagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 7
city: Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 144
city: Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 146
city: Fukushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 19
city: Fukuyama
country: Japan
facility: Boehringer Ingelheim Investigational Site 132
city: Gifu
country: Japan
facility: Boehringer Ingelheim Investigational Site 82
city: Hamamatsu
country: Japan
facility: Boehringer Ingelheim Investigational Site 83
city: Hatchioji
country: Japan
facility: Boehringer Ingelheim Investigational Site 56
city: Hayashima-machi
country: Japan
facility: Boehringer Ingelheim Investigational Site 129
city: Himeji
country: Japan
facility: Boehringer Ingelheim Investigational Site 123
city: Hirakata
country: Japan
facility: Boehringer Ingelheim Investigational Site 111
city: Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 133
city: Honjo
country: Japan
facility: Boehringer Ingelheim Investigational Site 30
city: Ichihara
country: Japan
facility: Boehringer Ingelheim Investigational Site 38
city: Ichikawasango-machi
country: Japan
facility: Boehringer Ingelheim Investigational Site 79
city: Ichikawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 37
city: Ikeda
country: Japan
facility: Boehringer Ingelheim Investigational Site 117
city: Isahaya
country: Japan
facility: Boehringer Ingelheim Investigational Site 149
city: Itami
country: Japan
facility: Boehringer Ingelheim Investigational Site 118
city: Iwamizawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 10
city: Izumo
country: Japan
facility: Boehringer Ingelheim Investigational Site 127
city: Kagoshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 154
city: Kagoshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 155
city: Kanazawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 74
city: Kanazawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 76
city: Katou
country: Japan
facility: Boehringer Ingelheim Investigational Site 120
city: Kawai-machi
country: Japan
facility: Boehringer Ingelheim Investigational Site 124
city: Kawasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 60
city: Kawasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 63
city: Keroyama-machi
country: Japan
facility: Boehringer Ingelheim Investigational Site 31
city: Kitakyuushu
country: Japan
facility: Boehringer Ingelheim Investigational Site 145
city: Kobe
country: Japan
facility: Boehringer Ingelheim Investigational Site 122
city: Kodaira
country: Japan
facility: Boehringer Ingelheim Investigational Site 46
city: Kodaira
country: Japan
facility: Boehringer Ingelheim Investigational Site 50
city: Koshigaya
country: Japan
facility: Boehringer Ingelheim Investigational Site 32
city: Kumamoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 150
city: Kumamoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 151
city: Kurume
country: Japan
facility: Boehringer Ingelheim Investigational Site 143
city: Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 102
city: Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 103
city: Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 98
city: Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 99
city: Maizuru
country: Japan
facility: Boehringer Ingelheim Investigational Site 100
city: Mat?uyama
country: Japan
facility: Boehringer Ingelheim Investigational Site 142
city: Matsumoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 80
city: Matsumoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 81
city: Mibu-machi
country: Japan
facility: Boehringer Ingelheim Investigational Site 28
city: Miki-machi
country: Japan
facility: Boehringer Ingelheim Investigational Site 138
city: Minoo
country: Japan
facility: Boehringer Ingelheim Investigational Site 115
city: Mitaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 47
city: Miyazaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 153
city: Miyoshi
country: Japan
facility: Boehringer Ingelheim Investigational Site 134
city: Moriguchi
country: Japan
facility: Boehringer Ingelheim Investigational Site 112
city: Morioka
country: Japan
facility: Boehringer Ingelheim Investigational Site 13
city: Muroran
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Nagakute-machi
country: Japan
facility: Boehringer Ingelheim Investigational Site 88
city: Nagaokakyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 101
city: Nagareyama
country: Japan
facility: Boehringer Ingelheim Investigational Site 41
city: Nagasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 148
city: Nagoya
country: Japan
facility: Boehringer Ingelheim Investigational Site 85
city: Nagoya
country: Japan
facility: Boehringer Ingelheim Investigational Site 86
city: Nagoya
country: Japan
facility: Boehringer Ingelheim Investigational Site 87
city: Nagoya
country: Japan
facility: Boehringer Ingelheim Investigational Site 92
city: Nigata
country: Japan
facility: Boehringer Ingelheim Investigational Site 68
city: Nigata
country: Japan
facility: Boehringer Ingelheim Investigational Site 69
city: Nigata
country: Japan
facility: Boehringer Ingelheim Investigational Site 70
city: Nigata
country: Japan
facility: Boehringer Ingelheim Investigational Site 71
city: Niihama
country: Japan
facility: Boehringer Ingelheim Investigational Site 139
city: Niihama
country: Japan
facility: Boehringer Ingelheim Investigational Site 141
city: Ninohe
country: Japan
facility: Boehringer Ingelheim Investigational Site 11
city: Nishinomiya
country: Japan
facility: Boehringer Ingelheim Investigational Site 121
city: Nishitokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 157
city: Odate
country: Japan
facility: Boehringer Ingelheim Investigational Site 17
city: Oita
country: Japan
facility: Boehringer Ingelheim Investigational Site 152
city: Okayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 130
city: Okayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 131
city: Okazaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 89
city: Osakasayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 113
city: Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 104
city: Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 105
city: Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 106
city: Ota
country: Japan
facility: Boehringer Ingelheim Investigational Site 128
city: Otsu
country: Japan
facility: Boehringer Ingelheim Investigational Site 97
city: Ozu
country: Japan
facility: Boehringer Ingelheim Investigational Site 140
city: Ryugasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 26
city: Sagamihara
country: Japan
facility: Boehringer Ingelheim Investigational Site 64
city: Saga
country: Japan
facility: Boehringer Ingelheim Investigational Site 147
city: Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site 34
city: Sakai
country: Japan
facility: Boehringer Ingelheim Investigational Site 107
city: Sakai
country: Japan
facility: Boehringer Ingelheim Investigational Site 108
city: Sakura
country: Japan
facility: Boehringer Ingelheim Investigational Site 39
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 4
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 5
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 6
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 8
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 9
city: Sendai
country: Japan
facility: Boehringer Ingelheim Investigational Site 14
city: Sendai
country: Japan
facility: Boehringer Ingelheim Investigational Site 15
city: Shimotsuke
country: Japan
facility: Boehringer Ingelheim Investigational Site 27
city: Shimotsuke
country: Japan
facility: Boehringer Ingelheim Investigational Site 29
city: Shingu
country: Japan
facility: Boehringer Ingelheim Investigational Site 125
city: Shizuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 84
city: Suzuka
country: Japan
facility: Boehringer Ingelheim Investigational Site 95
city: Suzuka
country: Japan
facility: Boehringer Ingelheim Investigational Site 96
city: Takamatsu
country: Japan
facility: Boehringer Ingelheim Investigational Site 137
city: Takatsuki
country: Japan
facility: Boehringer Ingelheim Investigational Site 109
city: Takatsuki
country: Japan
facility: Boehringer Ingelheim Investigational Site 110
city: Takizawa-mura
country: Japan
facility: Boehringer Ingelheim Investigational Site 12
city: Tokorozawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 33
city: Tokyo Arakawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 42
city: Tokyo Chuo
country: Japan
facility: Boehringer Ingelheim Investigational Site 53
city: Tokyo Itabashi
country: Japan
facility: Boehringer Ingelheim Investigational Site 43
city: Tokyo Meguro
country: Japan
facility: Boehringer Ingelheim Investigational Site 45
city: Tokyo Minato
country: Japan
facility: Boehringer Ingelheim Investigational Site 54
city: Tokyo Nerima
country: Japan
facility: Boehringer Ingelheim Investigational Site 49
city: Tokyo Nerima
country: Japan
facility: Boehringer Ingelheim Investigational Site 55
city: Tokyo Ota
country: Japan
facility: Boehringer Ingelheim Investigational Site 44
city: Tokyo Shibuya
country: Japan
facility: Boehringer Ingelheim Investigational Site 51
city: Tokyo Shibuya
country: Japan
facility: Boehringer Ingelheim Investigational Site 58
city: Tokyo Shinagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 57
city: Tokyo Shinjyuku
country: Japan
facility: Boehringer Ingelheim Investigational Site 48
city: Toride
country: Japan
facility: Boehringer Ingelheim Investigational Site 21
city: Tottori
country: Japan
facility: Boehringer Ingelheim Investigational Site 126
city: Toyama
country: Japan
facility: Boehringer Ingelheim Investigational Site 72
city: Toyama
country: Japan
facility: Boehringer Ingelheim Investigational Site 73
city: Toyohashi
country: Japan
facility: Boehringer Ingelheim Investigational Site 90
city: Toyohashi
country: Japan
facility: Boehringer Ingelheim Investigational Site 93
city: Toyokawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 91
city: Toyokawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 94
city: Toyonaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 114
city: Toyonaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 116
city: Tsuchiura
country: Japan
facility: Boehringer Ingelheim Investigational Site 20
city: Tsukuba
country: Japan
facility: Boehringer Ingelheim Investigational Site 24
city: Tsurugashima
country: Japan
facility: Boehringer Ingelheim Investigational Site 35
city: Tsuruga
country: Japan
facility: Boehringer Ingelheim Investigational Site 77
city: Urazoe
country: Japan
facility: Boehringer Ingelheim Investigational Site 156
city: Ushiku
country: Japan
facility: Boehringer Ingelheim Investigational Site 23
city: Ushiku
country: Japan
facility: Boehringer Ingelheim Investigational Site 25
city: Utinada-machi
country: Japan
facility: Boehringer Ingelheim Investigational Site 75
city: Yamagata
country: Japan
facility: Boehringer Ingelheim Investigational Site 18
city: Yanai
country: Japan
facility: Boehringer Ingelheim Investigational Site 135
city: Yokohama
country: Japan
facility: Boehringer Ingelheim Investigational Site 59
city: Yokohama
country: Japan
facility: Boehringer Ingelheim Investigational Site 61
city: Yokohama
country: Japan
facility: Boehringer Ingelheim Investigational Site 62
city: Yokohama
country: Japan
facility: Boehringer Ingelheim Investigational Site 65
city: Yokohama
country: Japan
facility: Boehringer Ingelheim Investigational Site 67
city: Yokose-machi
country: Japan
facility: Boehringer Ingelheim Investigational Site 159
city: Yoshinogawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 136
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: