UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015579 |
|---|---|
| Receipt number | 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 | 2021/11/10 18:17:04 |
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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
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
matsuoka_h@med.kindai.ac.jp
Sponsor or person
Institute
Department of Medical Oncology
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 21 | Day |
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
| 2021 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018105
