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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015579
Receipt No. R000018105
Scientific Title Research for selecting opioid using biomarker for cancer pain
Date of disclosure of the study information 2014/11/04
Last modified on 2016/05/20

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Basic information
Public title Research for selecting opioid using biomarker for cancer pain
Acronym RELIEF STUDY
Scientific Title Research for selecting opioid using biomarker for cancer pain
Scientific Title:Acronym RELIEF STUDY
Region
Japan

Condition
Condition Cancer Pain
Classification by specialty
Hematology and clinical oncology Psychosomatic Internal Medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The comparison of required dose of opioid
between genomic differences
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes The rate of high dose opioid on Day0
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine Gene
Interventions/Control_1 morphine COMT GG
Interventions/Control_2 oxycodone COMT GG
Interventions/Control_3 morphine COMT Non-GG
Interventions/Control_4 oxycodone COMT Non-GG
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria First screening registration entry
1 Patients with advanced malignant tumors
2 Opioid non daily use patients

Secondary screening registration entry
1 Cancer pain,that is targeted for the opioid treatment,taking NSAIDs or acetaminophen
2 NRS is 3 or more
3 Opioid treatment naive within 30 hours
4 Patients who have no influence on previous chemotherapy, radiation therapy
5 Written informed consent

Key exclusion criteria 1) patients with chronic renal failure (glomerular filtration rate, 30 mL/min),
2) patients with severe hepatic or respiratory failure
3) patients deemed ineligible for the study by the study coordinator or a collaborative investigator
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Nakagawa
Organization Kinki University, Faculty of Medicine
Division name Department of Medical Oncology
Zip code
Address 377-2, Ohno-higashi, Osakasayama City, Osaka, 589-8511
TEL 072-366-0221
Email nakagawa@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromichi Matsuoka
Organization Kinki University, Faculty of Medicine
Division name Palliative Care Center
Zip code
Address 377-2, Ohno-higashi, Osakasayama City, Osaka, 589-8511
TEL 072-366-0221
Homepage URL
Email matsuoka_h@med.kindai.ac.jp

Sponsor
Institute Department of Medical Oncology
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 04 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 Open public recruiting
Date of protocol fixation
2014 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 04 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
2014 Year 11 Month 01 Day
Last modified on
2016 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018105

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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