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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013824
Receipt No. 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

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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
Email 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
Email kurihara@gipc.akita-u.ac.jp

Sponsor
Institute Department of Chest, Breast and Endocrinologic Surgery, Akita University Graduate School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016134

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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