UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006672 |
|---|---|
| Receipt number | R000007881 |
| Scientific Title | Clinical study of treatment for intercostal neuralgia developed after thoracotomy |
| Date of disclosure of the study information | 2011/11/07 |
| Last modified on | 2013/11/12 19:08:13 |
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Basic information
Public title
Clinical study of treatment for intercostal neuralgia developed after thoracotomy
Acronym
Treatment for intercostal neuralgia after thoracotomy
Scientific Title
Clinical study of treatment for intercostal neuralgia developed after thoracotomy
Scientific Title:Acronym
Treatment for intercostal neuralgia after thoracotomy
Region
| Japan |
Condition
Condition
thoracotomy
Classification by specialty
| Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate possibility of new perioperative management by administration of Pregabalin and assessing its safety and efficacy for intercostal neuralgia after thoracotomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II,III
Assessment
Primary outcomes
-Control rate of pain at the incision site after surgery; NRS on the third month after surgery
Key secondary outcomes
-Control rate of pain at the incision site after surgery; NRS on the first, third, and seventh day after surgery, VAS in the fourth and eighth week after surgery
-Control the level of pain according to the type of pain (neurophathic pain or nociceptive pain)
- Occurrence rate of adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment group (Pregabalin group)
Interventions/Control_2
control group (NSAID group)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) patients who are ages 20-70
(2) patients who are PS 0, 1 (ECOG)
(3) patients who undergo respiratory surgery that requires intercostal manipulation
(4) patients who have normal kidney function with creatinine clearance >30ml/min
(5) patients who have signed the consent form to participate in this study
Key exclusion criteria
(1) patients who have been taking antidepressants, anticonvulsant, opoids, and NSAIDs before surgery
(2) patients who have serious complications (such as uncontrollable heart, lung, liver or kidney disease, and diabetes)
(3) patients who have a history of angioedema
(4) patients who are pregnant, are nursing, or might be pregnant (voluntary)
(5) patients who handle hazardous machinery, such as driving a car
(6) patients who are considered unsuitable for the study by the primary physician
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Matsutani |
Organization
Teikyo University, school of Medicine
Division name
Surgery
Zip code
Address
2-11-1 Kaga Itabashi-ku Tokyo, 173-8605 Japan
TEL
+81-3-3964-1231
matsutani1970@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Matsutani |
Organization
Teikyo University, School of Medicine
Division name
Surgery
Zip code
Address
2-11-1 Kaga Itabashi-ku Tokyo, 173-8605 Japan
TEL
+81-3-3964-1231
Homepage URL
matsutani1970@yahoo.co.jp
Sponsor or person
Institute
Teikyo University, School of Medicine, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Pfizer
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
帝京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 07 | 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
| 2011 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 04 | Day |
Last modified on
| 2013 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007881
