UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035523 |
|---|---|
| Receipt number | R000040470 |
| Scientific Title | An exploratory observational study of clinical significance of PK/PD (pharmacokinetic/pharmacodynamic) concentration after opioid to patients with urological cancer pain |
| Date of disclosure of the study information | 2019/01/11 |
| Last modified on | 2026/01/16 09:24:59 |
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Basic information
Public title
An exploratory observational study of clinical significance of PK/PD (pharmacokinetic/pharmacodynamic)
concentration after opioid to patients with urological cancer pain
Acronym
The investigation of (pharmacokinetic/pharmacodynamic) of opioid
Scientific Title
An exploratory observational study of clinical significance of PK/PD (pharmacokinetic/pharmacodynamic)
concentration after opioid to patients with urological cancer pain
Scientific Title:Acronym
The investigation of (pharmacokinetic/pharmacodynamic) of opioid
Region
| Japan |
Condition
Condition
Patients using opioids for urological cancer pain
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verify whether changes in opioid blood levels can predict analgesic effects
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between changes in opioid blood levels and changes in pain
Key secondary outcomes
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients using opioid analgesics.
2)Patient who agreed.
3)Patient whose pain is controlled.The number of times of rescue drug use is up to 4 times a day.
4)Patient who can communicate.
Key exclusion criteria
1)patients who had allergy in oxycodone.
2)patients who had allergy in Fentanyl.
3)patients who had allergy in Tapentadol.
4)patients who had allergy in morphine.
5)patients who had allergy in Hydromorphone.
6)patients who had allergy in methadone.
7)patients including severe adverse event.
8)pregnant patients/patients giving lactation
9)Patient with difficult blood sampling
10)unadequate patients
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Keitaro |
| Middle name | |
| Last name | Iida |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Clinical Pharmaceutics
Zip code
467-8601
Address
kawasumi 1, mizuho-cho, mizuho-ku, Nagoya, Japan
TEL
0528515511
ikeitarou1009@gmail.com
Public contact
Name of contact person
| 1st name | yosuke |
| Middle name | |
| Last name | sugiyama |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Clinical Pharmaceutics
Zip code
467-8601
Address
kawasumi 1, mizuho-cho, mizuho-ku, Nagoya, Japan
TEL
052-851-5511
Homepage URL
phsugi@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Grant-Aid from the Ministry of Education, Culture, Sports Science and Technology of Japan
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
Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital Institutional Review Board
Address
1 kawasumi, mizuho-cho, mizuho-ku
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 | 01 | Month | 11 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000040470
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/jjco/advance-article-abstract/doi/10.1093/jjco/hyaf210/8424211?redirectedFr
Number of participants that the trial has enrolled
16
Results
In the linear mixed-effects model, simulated serum oxycodone concentrations were significantly associated with lower NRS scores.AlthoughneitherheartratenorstepcountindependentlypredictedNRS,incorporating heart rate into the modelimproved the overall fit. Thus, heart rate may capture pain-related physiological responses not fully explained by oxycodone concentration alone, thereby enhancing the explanatory power of the model.
Results date posted
| 2026 | Year | 01 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This observational study enrolled 16 patients aged over 20 years with cancer-related pain who received oxycodone between 2019 and 2023, including those with advanced urological cancer. The inclusion criteria were as follows: (i) use of opioid analgesics; controlled pain, defined as requiring no more than four rescue doses per day; and the ability to communicate. The exclusion criteria were as follows: known allergy to oxycodone, experience of severe adverse events, pregnancy or lactation, difficulty undergoing blood sampling, and any other condition deemed unsuitable by the investigators
Participant flow
The study protocol was approved by the Ethics Committee of Nagoya City University Hospital (Approval No.60-18-0144).
All participants provided written informed consent, and the study was conducted in accordance with the Declaration of Helsinki (2013 revision)
Adverse events
Not applicable
Outcome measures
Demographic data, cancer type, metastatic sites, pain locations, and information on concomitant treatments were extracted from electronic medical records. Pain intensity was assessed using a single item numerical rating scale as a patient reported outcome, recorded by the clinical staff at least once daily during ward rounds and at the time of blood sampling. Drug administration records and NRS time points were synchronized with the wearable data using the hospitals internal timekeeping system. A wrist worn activity tracker was used to monitor heart rate and step count throughout the observation period. The device utilizes proprietary algorithms validated in previous studies to estimate the heart rate and physical activity levels. Heart rate accuracy has been demonstrated in a previous validation study. Fitbit data were stored on the Fitbit cloud, and investigators exported heart rate and step-count values recorded at 5min intervals via the paired application. Heart rate and step count were selected because they were the most complete and reliable data streams across participants, and step count had demonstrated feasibility and clinical utility in our previous prospective study
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not applicable
Management information
Registered date
| 2019 | Year | 01 | Month | 11 | Day |
Last modified on
| 2026 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040470
