UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013824 |
|---|---|
| Receipt number | R000016134 |
| Scientific Title | Efficacy and safety of lidocaine hydrochloride jelly for extubation of thoracic drainage tube after thoracic surgery. |
| Date of disclosure of the study information | 2014/04/30 |
| Last modified on | 2016/01/06 15:07:16 |
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Basic information
Public title
Efficacy and safety of lidocaine hydrochloride jelly for extubation of thoracic drainage tube after thoracic surgery.
Acronym
Efficacy and safety of lidocaine hydrochloride jelly for extubation of thoracic drainage tube.
Scientific Title
Efficacy and safety of lidocaine hydrochloride jelly for extubation of thoracic drainage tube after thoracic surgery.
Scientific Title:Acronym
Efficacy and safety of lidocaine hydrochloride jelly for extubation of thoracic drainage tube.
Region
| Japan |
Condition
Condition
Patients with chest tube after lung cancer radical operation.
Classification by specialty
| Surgery in general | Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of lidocaine hydrochloride jelly for extubation of thoracic drainage tube after thoracic surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Wound pain and pain of extubation thoracic tube.
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lidocaine hydrochloride jelly 20mg/1ml
Lidocaine hydrochloride cream 70mg/1ml
Interventions/Control_2
Pracebo (sterilized jelly)
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Shall meet the followin:
1) The case has been received a lung cancer radical operation and patients between 20 to 79 years of age.
2) The outstanding cases of enforced chemoradiationtherapy for lung cancer.
3) Performance Status (ECOG) of 0-1, and The American Society of Anesthesiologists physical status 0-1.
4) The outstanding cases of diabetes.
5) has the following organ function, adequate bone marrow, liver and renal function patients are kept
White blood cell count >and= 3,000 / mm3
Neutrophil count >and= 1,500 / mm3
Platelet count >and= 100,000 / mm3
hemoglobin >and= 9.5g/dL
AST / ALT; Less than 2.5 times the upper limit of normal facility
Total Bilirubin <and= 1.5mg / dL
Serum creatinene; more than 1.5 times the upper limit of normal
SpO2 (Room air) 90% (PaO2 65mmHg or more)
Less than 1+ proteinuira
6) At the time of the start date of administration, the patient has the following period has elapsed from prior treatment
(1) radiation therapy
For non-radiation to the chest: Longer than two weeks from the date of last exposure
(2)surgical procedure (including pleurodesis)
Without surgery lobectomy (include thoracotomy) 4 or more weeks
Finish treatment (pleurodesis) more than two weeks
7) received a description of the contents of this trial, patient consent was obtained from the documents themselves
Key exclusion criteria
But if any one of the following will be excuded.
1) radiotherapy (radiation to the chest than excluded)
2) chemotherapy
3) patients with previously untreated brain metastasis
4) patients with infectious diseases and clinical problems
5) interstital pneumonia, pneumonitis, radiation pneumonitis, pulmonary infections, pulmonary fibrosis, patients have been complicated by pneumonia and other pulmonary disorder drug
6) clinical problems and complications (abnormal electrocardiogram, cardiac dysfunction, arrhythemias, and sever heart disease), patients with
7) patients with diabetes
8) patients with a large amount of ascites cardiac effusion pleural effusion
9) activity in patients with cancers
10) patients with a history of severe drug allergy
11) in patients who are pregnant or potentially pregnant lactating
12) In addition, patients were deemed unsuitable for the safe conduct of the study doctor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyasu Kurihara |
Organization
Akita University Graduate School of Medicine
Division name
Department of Chest, Breast and Endocrinologic Surgery
Zip code
Address
1-1-1 Hondo, Akita, Japan
TEL
018-884-6132
kurihara@gipc.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyasu Kurihara |
Organization
Akita University Graduate School of Medicine
Division name
Department of Chest, Breast and Endocrinologic Surgery
Zip code
Address
1-1-1 Hondo, Akita, Japan
TEL
018-884-6132
Homepage URL
kurihara@gipc.akita-u.ac.jp
Sponsor or person
Institute
Department of Chest, Breast and Endocrinologic Surgery, Akita University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Chest, Breast and Endocrinologic Surgery, Akita University Graduate School of Medicine
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
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 | 04 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 04 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 07 | 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 | 04 | Month | 28 | Day |
Last modified on
| 2016 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016134
| 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 |
