UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014438 |
|---|---|
| Receipt number | R000015053 |
| Scientific Title | Effect of Pregabalin on Endogenous analgesia in healthy adults |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2015/02/01 17:37:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of Pregabalin on Endogenous analgesia in healthy adults
Acronym
Effect of Pregabalin on Endogenous analgesia in healthy adults
Scientific Title
Effect of Pregabalin on Endogenous analgesia in healthy adults
Scientific Title:Acronym
Effect of Pregabalin on Endogenous analgesia in healthy adults
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to examine whether pregabalin modulates endogenous analgesia in healthy adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We examine effect of pregabalin on endogenous analgesia compared to placebo by measuring variation of conditioning pain modulation (CPM).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
take pregabalin.
Mesurement of endogenous pain modulation
Interventions/Control_2
take placebo.
Mesurement of endogenous pain modulation
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
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy adults
age: from 20 years or older to 55 years or younger
Key exclusion criteria
patients with chronic pain
patients who can't understand the protocol.
patients who can't bear the heat stimulus.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Obata |
Organization
Gunma University Hospital
Division name
Department of Anesthesiology
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8454
hobata@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satomi Sugimine |
Organization
Gunma University Hospital
Division name
Department of Anesthesiology
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8454
Homepage URL
s-satomi@umin.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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 | 07 | Month | 01 | 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
| 2013 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 01 | Day |
Last modified on
| 2015 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015053
