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Recruitment status Completed
Unique ID issued by UMIN UMIN000006672
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email matsutani1970@yahoo.co.jp

Sponsor
Institute Teikyo University, School of Medicine, Department of Surgery
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007881


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