Unique ID issued by UMIN | UMIN000004179 |
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Receipt number | R000005019 |
Scientific Title | Thalidomide Treatment for Crow Fukase (POEMS) Syndrome: A Multicenter, Randomized, Double blind, Placebo controlled, Parallel group Trial with an Extension Phase to Evaluate the Long term Safety |
Date of disclosure of the study information | 2010/09/10 |
Last modified on | 2016/07/28 10:38:52 |
Thalidomide Treatment for Crow Fukase (POEMS) Syndrome: A Multicenter, Randomized, Double blind, Placebo controlled, Parallel group Trial with an Extension Phase to Evaluate the Long term Safety
J - POST Trial
Thalidomide Treatment for Crow Fukase (POEMS) Syndrome: A Multicenter, Randomized, Double blind, Placebo controlled, Parallel group Trial with an Extension Phase to Evaluate the Long term Safety
J - POST Trial
Japan |
Crow-Fukase (POEMS)syndrome
Neurology |
Others
NO
To evaluate the efficacy and safety of FPF 300 (thalidomide) compared to placebo in patients with Crow-Fukase (POEMS) syndrome and also to evaluate the long-term safety and efficacy of FPF 300.
Safety,Efficacy
Reduction rate of serum VEGF level at 24 weeks
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
FPF300 100-300mg/day
FPF300-palacebo 100-300mg/day
20 | years-old | <= |
Not applicable |
Male and Female
(1) Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria)
(2) Over 20 years old
(3) Patients whose ECOG Performance Status not exceeding 3
(4) Patients whose overall neuropathy limitaion scale not exceeding 9
(5) Patients whose liver function test and renal function test are within below limits. AST (GOT) smaller than 4.0 X upper limit of normal ALT (GPT) smaller than 4.0 X upper limit of normal Creatinine smaller than 1.5 X upper limit of normal
(6) Patients who are capable of undergoing in hospital examinations at the time of starting and quitting the trial.
(7) Patients who are capable of ambulatory hospital visits.
(8) Patients who have an clinicaly probrematic ECG
(9) Patients with written informed consent.
(10) Patients who are not candidates for high dose chemotherapy with autologous stem cel rescue
(11) Patients with informed consent to thalidomide education and risk management system
(1) Patients who have recieved thalidomide, melpharan, or bortezomib within 24 weeks prior to the informed consent.
(2) Pateints who could worsen acutely during the clinical trial period
(3) Patients who have recieved oral or intravenous administration of steroid (not including inhalant) within 4 weeks of providing informed consent.
(4) Females who are pregnant or desire childbearing. Males who desire fertility
(5) Patients who have severe complications (cardiac failure, renal failure, liver failure, bleedin ulcer, ileus, diabetes with poorly controlled hyperglycemia)
(6) Patients who have other malignancy
(7) Patients with past medical history of allergy to thalidomide or dexamethasone
(8) Patients with serious mental disorder
(9) Patients who have participated in other clinical trials within 12 weeks prior to the informed consent.
(10) Patients who have received drugs or therapy prohibited in the clinical trial within 4 weeks
(11) Patients who are not appropriate to participate to the trial
24
1st name | |
Middle name | |
Last name | Satoshi Kuwabara |
Chiba University, Graduate School of Medicine
Department of Neurology
Inohana 1-8-1, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
043-222-7171
kuwabara-s@faculty.chiba-u.jp
1st name | |
Middle name | |
Last name | Sonoko Misawa |
Chiba University, Graduate School of Medicine
Department of Neurology
Inohana 1-8-1, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
043-222-7171
http://www.m.chiba-u.ac.jp/class/neurol/kenkyu/ishisyudou/index.html
sonoko.m@mb.infoweb.ne.jp
Chiba University, Graduate School of Medicine
Japan Medical Association
Other
Japan
NO
北海道大学(北海道)、北海道医療センター(北海道)、東北大学(宮城県)、千葉大学(千葉県)、埼玉医科大学(埼玉県)、新潟大学(新潟県)、信州大学(長野県)、名古屋大学(愛知県)、近畿大学(大阪府)、神戸市立医療センター中央市民病院(兵庫県)、山口大学(山口県)、九州大学(福岡県)、鹿児島大学(鹿児島県)
2010 | Year | 09 | Month | 10 | Day |
http://opac.ll.chiba-u.jp/da/curator/100005/?lang=1
Unpublished
Completed
2010 | Year | 05 | Month | 31 | Day |
2010 | Year | 11 | Month | 11 | Day |
2010 | Year | 09 | Month | 09 | Day |
2016 | Year | 07 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005019
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