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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000022072
Receipt No. R000024676
Scientific Title A trial evaluating the efficacy and safety of Laftidine for protection against vincristine-induced peripheral neuropathy.
Date of disclosure of the study information 2016/04/26
Last modified on 2019/04/28

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Basic information
Public title A trial evaluating the efficacy and safety of Laftidine for protection against vincristine-induced peripheral neuropathy.
Acronym A trial evaluating the efficacy and safety of Laftidine for vincristine-induced peripheral neuropathy.
Scientific Title A trial evaluating the efficacy and safety of Laftidine for protection against vincristine-induced peripheral neuropathy.
Scientific Title:Acronym A trial evaluating the efficacy and safety of Laftidine for vincristine-induced peripheral neuropathy.
Region
Japan

Condition
Condition Malignant lymphoma
Classification by specialty
Medicine in general Hematology and clinical oncology Neurology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We aim to clarify the efficacy and safety of Laftidine for protection against vincristine-induced peripheral neuropathy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint was the incidence of peripheral neuropathy grade 1 with neuropathic pain and grater than Grade2 as graded by the CTCAE v. 4.0 criteria.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 lafutidine was administered orally at a dose of 10 mg twice a day from the first course to the forth course.
Interventions/Control_2
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 diagnosed as Malignant lymphoma and indicated for chemotherapy that contains vincristine. (1.4mg/m2 max 2mg)
2. Patients indicated for administration of H2-receptor antagonist or proton pump inhibitors.
3. Patients older than 20 years
4. Patients without severe liver failure( AST or ALT is greater than three times the upper limit of normal) and kidney failure(estimated EGFR is less than 50ml / min)
5. Patients with performance status 0-2
6. Patients accepted the participation for this study after full explanation and understanding of the content s of this study
Key exclusion criteria 1. Patients with hypersensitivity reaction for lafutidine
2. Patients with active disease except for malignant lymphoma.
3. Patients with peripheral neuropathy.
4. Patients with oral drugs that affect the neurological disorder.(Methylcobalamin, Anticonvulsants(Pregabalin, Gabapentin , Carbamazepine) , Tricyclic antidepressants( Amitriptyline, Nortriptyline, Amoxapine) ,Serotonin and norepinephrine reuptake inhibitors(Duloxetine), Antiarrhythmic drugs(Mexiletine, Flecainide) , Goshajinkigan, Shakuyakukanzoutou, etc.)
5. The patients who are receiving H2 antagonist or proton pump inhibitors, and who cannot stop these drugs.
6. Patients who require administration of Intrathecal chemotherapy.
7. Patients with severe hypersensitivity reaction for any medications.
8. Patients with HIV infection
9. Pregnant women.
10. Breast feeding women.
11. Patients who considered that participation in this trial is difficult because of psychiatric symptoms or psychosis
12. Patients who do not agree with his or her intention
13. Patients whom the doctor recognizes unsuitable subject.

Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuzuru Kanakura
Organization Osaka University Graduate School of Medicine
Division name Department of Hematology and Oncology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL +81-6-6879-3871
Email handai-cbc-jimu@bldon.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Oritani
Organization Osaka University Graduate School of Medicine
Division name Department of Hematology and Oncology
Zip code
Address Department of Hematology and Oncology
TEL +81-6-6879-3871
Homepage URL
Email handai-cbc-jimu@bldon.med.osaka-u.ac.jp

Sponsor
Institute Department of Hematology and Oncology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Hematology and Oncology, Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 大阪府立成人病センター(大阪府):Osaka Medical Center for Cancer and Cardiovascular Diseases(Osaka)
NTT西日本大阪病院(大阪府): NTT WEST Osaka Hospital(Osaka)
県立西宮病院(兵庫県):Hyogo Prefectural Nishinomiya Hospital(Hyogo)
大手前病院(大阪府):Otemae Hospital(Osaka)
市立芦屋病院(兵庫県):Ashiya Municipal Hospital(Hyogo)
市立池田病院(大阪府):Ikeda City Hospital(Osaka)
市立伊丹病院(大阪府):Itami City Hospital(Osaka)
堺市立総合医療センター(大阪府):Sakai City Medical Center(Osaka)
市立吹田病院(大阪府):Suita Municipal Hospital(Osaka)
市立豊中病院(大阪府):Toyonaka Municipal Hospital(Osaka)
住友病院(大阪府):Sumitomo Hospital(Osaka)
日生病院(大阪府):Nissay Hospital(Osaka)
市立箕面病院(大阪府):Minoh City Hospital(Osaka)
りんくう総合医療センター(大阪府):Rinku General Medical Center(Osaka)
八尾市立病院(大阪府):Yao Municipal Hospital(Osaka)
関西労災病院(兵庫県):Kansai Rosai Hospital(Hyogo)
国立病院機構大阪医療センター(大阪府): National Hospital Organization Osaka National Hospital(Osaka)
医療法人川崎病院(兵庫県):Kobe Kawasaki Hospital(Hyogo)
市立川西病院(大阪府):Kawanishi City Hospital(Osaka)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 26 Day

Related information
URL releasing protocol
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 Terminated
Date of protocol fixation
2016 Year 04 Month 26 Day
Date of IRB
2016 Year 03 Month 08 Day
Anticipated trial start date
2016 Year 05 Month 23 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 26 Day
Last modified on
2019 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024676

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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