UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007590 |
|---|---|
| Receipt number | R000008354 |
| Scientific Title | Effect of pregabarin for intercostal neuralgia associated with Stoney incision after thoracic aortic replacement |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2023/10/09 11:46:31 |
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Basic information
Public title
Effect of pregabarin for intercostal neuralgia associated with Stoney incision after thoracic aortic replacement
Acronym
PRETH study
Scientific Title
Effect of pregabarin for intercostal neuralgia associated with Stoney incision after thoracic aortic replacement
Scientific Title:Acronym
PRETH study
Region
| Japan |
Condition
Condition
thoracic aortic aneurysm requiring Stoney incision
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of pregabarin for intercostal neuralgia associated with Stoney incision
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in pain score (Visual Analog Scale; VAS) between pre- and post-medcation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pregabarin 150mg/day for 30 days
Interventions/Control_2
placebo for 30 days
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients undergoing thoracic aortic repair through a Stoney incision
Key exclusion criteria
-pregnant woman
-less than 40 mm of maximal level of visual analogue scale (VAS) for 4 days following extubation (cf. )(0 mm, no pain; 100 mm, worst pain imaginable)
-diabateic patietns with neuropathy
-patients with neuropathy from organic brain syndrome
-allergy to pregabalin
-patients with severe liver dysfuntion (CTCAE grade 3 or 4)
-patients who have taken analgesic regularly
-patient who does not consent to this study
-patient who is deemed by a physician to be unsuitable for study entry
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshikatsu |
| Middle name | |
| Last name | Saiki |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Cardiovascular Surgery
Zip code
980-8574
Address
1-1 Seiryocho, Aoba-ku, Sendai 980-8574, Japan
TEL
022-717-7222
yoshisaiki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Matsuo |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Cardiovascular Surgery
Zip code
980-8574
Address
1-1 Seiryocho, Aoba-ku, Sendai 980-8574, Japan
TEL
022-717-7222
Homepage URL
a0mb1082-thk@umin.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine
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
IRB of Tohoku University Graduate School of Medicine
Address
1-1 Seiryocho, Aoba-ku, Sendai 980-8574, Japan
Tel
022-717-8007
med-kenkyo@bureau.tohoku.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
東北大学大学院医学系研究科心臓血管外科
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | 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
60
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
| 2012 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 28 | Day |
Last modified on
| 2023 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008354
| 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 |
