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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011301
Receipt No. R000013245
Scientific Title The efficacy of lafutidine for nab-paclitaxel-induced peripheral neuropathy
Date of disclosure of the study information 2013/07/29
Last modified on 2015/08/04

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Basic information
Public title The efficacy of lafutidine for nab-paclitaxel-induced peripheral neuropathy
Acronym The efficacy of lafutidine for nab-paclitaxel-induced peripheral neuropathy
Scientific Title The efficacy of lafutidine for nab-paclitaxel-induced peripheral neuropathy
Scientific Title:Acronym The efficacy of lafutidine for nab-paclitaxel-induced peripheral neuropathy
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To reveal the efficacy of lafutidine for nab-paclitaxel-induced peripheral neuropathy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Patient Neurotixicity Questionnaire(PNQ) and CTCAE v4.0
Key secondary outcomes adverse event

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Lafutidine is administered orally at the dose of 10 mg twice daily for 9 weeks
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1)breast cancer patient who are planning to chemotherapy using nab-paclitaxel
2)Cases it is considered to be performed to continue treatment with nab-paclitaxel 4 weeks or more
3)age: >=20 and =<75
4)peripheral neuropathy is not expressed
5)expected more than 6 months survival
6)written informed consent
Key exclusion criteria 1)with severe complications (such as liver failure, renal failure, heart failure)
2)with history of allergy
3)case of taking pregabalin
4)doctor's decision not to be registered to this study
Target sample size 24

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Itaru Endo
Organization Yokohama City University Hospital
Division name gastroenterological surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-787-2800
Email endoit@med.yokohama-cu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Sadatoshi SUGAE
Organization Yokohama City University Hospital
Division name Gastroenterological surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-787-2800
Homepage URL
Email sugae@f7.dion.ne.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Yokohama Clinical Oncology Group
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 横浜市立大学附属病院(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
横須賀共済病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

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
2013 Year 06 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 29 Day
Last follow-up date
2014 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 29 Day
Last modified on
2015 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013245

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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