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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035523
Receipt No. R000040470
Official scientific title of the study 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 2019/01/17

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Basic information
Official scientific title of the study An exploratory observational study of clinical significance of PK/PD (pharmacokinetic/pharmacodynamic)
concentration after opioid to patients with urological cancer pain
Title of the study (Brief title) 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 Kazunori Kimura
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Clinical Pharmaceutics
Address kawasumi 1, mizuho-cho, mizuho-ku, Nagoya, Japan
TEL 052-851-5511
Email kkimura@med.nagoya-cu.ac.jp

Public contact
Name of contact person yosuke sugiyama
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Clinical Pharmaceutics
Address kawasumi 1, mizuho-cho, mizuho-ku, Nagoya, Japan
TEL 052-851-5511
Homepage URL
Email phsugi@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 10 Day
Anticipated trial start date
2019 Year 01 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information not applicable

Management information
Registered date
2019 Year 01 Month 11 Day
Last modified on
2019 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040470

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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