UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017054 |
|---|---|
| Receipt number | R000019778 |
| Scientific Title | Evaluation of analgesic effects in healthy adults. -Using Cold Pressor Test- |
| Date of disclosure of the study information | 2015/05/11 |
| Last modified on | 2015/12/15 14:58:28 |
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Basic information
Public title
Evaluation of analgesic effects in healthy adults.
-Using Cold Pressor Test-
Acronym
Evaluation of analgesic effects after administration of analgesics using Cold Pressor Test.
Scientific Title
Evaluation of analgesic effects in healthy adults.
-Using Cold Pressor Test-
Scientific Title:Acronym
Evaluation of analgesic effects after administration of analgesics using Cold Pressor Test.
Region
| Japan |
Condition
Condition
Cancer Pain
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analgesic effects after the administration of Oxycodone HCL (10mg) or placebo will be compared using 2x2 crossover methods.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Analgesic effects of Oxycodone HCL administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single oral administration of Oxycodone HCL (10mg)
Interventions/Control_2
Single oral administration of placebo
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1, Healthy Japanese male subjects who provide signed written informed consent.
2, Subjects between 20 and 40 (inclusive) year of age at the time of consent.
3, Subjects with BMI <=18.5 and >25.0 at the time of screening.
4, Subjects judged as adequate for this study by study physician.
Key exclusion criteria
1, Subjects with present illness which requires treatment.
2, Subjects with past medical history which was considered not adequate for this study.
3, Subjects with past history of drug allergy.
4, Subjects with history of caffeine, alcohol and/or drug abuse.
5, Subjects who was judged not appropriate for this study by study physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanari Shiramoto |
Organization
Medical Co. LTA Hakata Clinic
Division name
Clinical Pharmacology Department
Zip code
Address
Random Square (5th-7th floors), 6-18 Tenyamachi, Hakata-ku, Fukuoka 812-0025
TEL
0922837701
masanari-shiramoto@lta-med.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hinako Uchimaru |
Organization
Medical Co. LTA Hakata Clinic
Division name
Planning & Coordination Dept.
Zip code
Address
Random Square (5th-7th floors), 6-18 Tenyamachi, Hakata-ku, Fukuoka 812-0025
TEL
0922837701
Homepage URL
hinako-uchimaru@lta-med.com
Sponsor or person
Institute
Medical Co. LTA Hakata Clinic
Institute
Department
Personal name
Funding Source
Organization
None
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
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
医療法人相生会 博多クリニック（福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Poster presentation at the 36th Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics (Dec.9-11,2015) "Phamacodynamic evaluation of analgesics in healthy subjects - evaluation of Cold Pressor Test-"
Management information
Registered date
| 2015 | Year | 04 | Month | 06 | Day |
Last modified on
| 2015 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019778
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
