UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038924 |
|---|---|
| Receipt number | R000044347 |
| Scientific Title | Pilot study of low-dose methadone as adjuvant to regular opioid therapy for refractory cancer pain |
| Date of disclosure of the study information | 2019/12/23 |
| Last modified on | 2023/06/21 09:05:31 |
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Basic information
Public title
Pilot study of low-dose methadone as adjuvant to regular opioid therapy for refractory cancer pain
Acronym
Pilot study of low-dose methadone as an adjuvant analgesic
Scientific Title
Pilot study of low-dose methadone as adjuvant to regular opioid therapy for refractory cancer pain
Scientific Title:Acronym
Pilot study of low-dose methadone as an adjuvant analgesic
Region
| Japan |
Condition
Condition
cancer pain
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
the efficacy and safety of low-dose methadone as adjuvant to regular opioid therapy for refractory cancer pain
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the percentages of patients with pain reduction from enrollment
Key secondary outcomes
pain(NRS), adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
patients with cancer suffering from pain are enrolled if they are non-responsive to another opioid therapy(>=60 mg OME/day).
Key exclusion criteria
severe cognitive disorders
QT prolongation
contraindication for methadone
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Hasegawa |
Organization
Nagoya City University Hospital
Division name
Center for Psycho-oncology and Palliative Care
Zip code
467-8602
Address
Mizuho-cho, Mizuho-ku Nagoya
TEL
052-851-5511
takaaki_hase@bird.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Hasegawa |
Organization
Nagoya City University Hospital
Division name
Center for Psycho-oncology and Palliative Care
Zip code
467-8602
Address
Mizuho-cho, Mizuho-ku Nagoya
TEL
052-851-5511
Homepage URL
takaaki_hase@bird.ocn.ne.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Management Center, Nagoya City University Hospital
Address
Mizuho-cho, Mizuho-ku Nagoya
Tel
052-858-7215
clinical_research@med.nagoya-cu.ac.jp
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
| 2019 | Year | 12 | Month | 23 | 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
19
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pain(NRS) at day7, 14, 28
Adverse events(constipation, nausea, vomiting, somnolence, delirium, etc)
other opioid use
frequency of rescue use
Management information
Registered date
| 2019 | Year | 12 | Month | 18 | Day |
Last modified on
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044347
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
