UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012984 |
|---|---|
| Receipt number | R000015162 |
| Scientific Title | Association between depression symptom and sharp pain with intercostal neuralgia after thoracoscopic surgery for lung cancer |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2015/01/27 09:35:34 |
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Basic information
Public title
Association between depression symptom and sharp pain with intercostal neuralgia after thoracoscopic surgery for lung cancer
Acronym
Association between depression symptom and sharp pain with intercostal neuralgia after thoracoscopic surgery for lung cancer
Scientific Title
Association between depression symptom and sharp pain with intercostal neuralgia after thoracoscopic surgery for lung cancer
Scientific Title:Acronym
Association between depression symptom and sharp pain with intercostal neuralgia after thoracoscopic surgery for lung cancer
Region
| Japan |
Condition
Condition
intercostal neuralgia
Classification by specialty
| Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate possibility of new perioperative management by administration of Duloxetine and assessing its efficacy for depression symptom associated with intercostal neuralgia after thoracoscopic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II,III
Assessment
Primary outcomes
Control rate of pain and depression after surgery; BDI and VAS on the three week and five week after administration for depression symptom associated with intercostal neuralgia after thoracoscopic surgery.
Key secondary outcomes
QOL improvement evaluated by BPI.
General condition improvement evaluated by CGI.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment group (Duloxetine group)
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
patients who are more than 30 mm in VAS
patients who are more than 11 points in BDI
(1) patients who are ages 20-80
(2) patients who are PS 0, 1 (ECOG)
(3) patients who undergo thoracoscopic surgery for lung cancer
(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 peptic ulcer, aspirin-induced asthma, closed angle glaucoma
(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
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Hokka |
Organization
Kobe University Graduate School of Medicine, Kobe, Japan
Division name
Division of Thoracic Surgery, Department of Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city, 650-0017, Japan, 81
TEL
078-382-5750
dhokka@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Hokka |
Organization
Kobe University Graduate School of Medicine, Kobe, Japan
Division name
Division of Thoracic Surgery, Department of Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city, 650-0017, Japan, 81
TEL
078-382-5750
Homepage URL
dhokka@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine, Kobe, Japan
Institute
Department
Personal name
Funding Source
Organization
Kobe university hospital
Organization
Division
Category of Funding Organization
Other
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
神戸大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 01 | Month | 27 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 28 | Day |
Last modified on
| 2015 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015162
