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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004179
Receipt No. 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

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Basic information
Public 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
Acronym J - POST Trial
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
Scientific Title:Acronym J - POST Trial
Region
Japan

Condition
Condition Crow-Fukase (POEMS)syndrome
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reduction rate of serum VEGF level at 24 weeks
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 FPF300 100-300mg/day
Interventions/Control_2 FPF300-palacebo 100-300mg/day
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (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
Key exclusion criteria (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
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Kuwabara
Organization Chiba University, Graduate School of Medicine
Division name Department of Neurology
Zip code
Address Inohana 1-8-1, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
TEL 043-222-7171
Email kuwabara-s@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sonoko Misawa
Organization Chiba University, Graduate School of Medicine
Division name Department of Neurology
Zip code
Address Inohana 1-8-1, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
TEL 043-222-7171
Homepage URL http://www.m.chiba-u.ac.jp/class/neurol/kenkyu/ishisyudou/index.html
Email sonoko.m@mb.infoweb.ne.jp

Sponsor
Institute Chiba University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Medical Association
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 10 Day

Related information
URL releasing protocol http://opac.ll.chiba-u.jp/da/curator/100005/?lang=1
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 09 Day
Last modified on
2016 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005019

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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