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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029348
Receipt No. R000031896
Scientific Title A study of efficacy and safety of landiolol hydrochloride for pulmonary resection
Date of disclosure of the study information 2017/10/01
Last modified on 2018/10/29

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Basic information
Public title A study of efficacy and safety of landiolol hydrochloride for pulmonary resection
Acronym A study of landiolol hydrochloride for pulmonary resection
Scientific Title A study of efficacy and safety of landiolol hydrochloride for pulmonary resection
Scientific Title:Acronym A study of landiolol hydrochloride for pulmonary resection
Region
Japan

Condition
Condition patients who underwent pulmonary resection
Classification by specialty
Chest surgery Anesthesiology Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the outcome of patients who underwent pulmonary resection with/without landiolol hydrochloride
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 2-year relapse free survival rate
Key secondary outcomes Relapse free survival, overall survival

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 landiolol hydrochloride
Interventions/Control_2 placebo
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

Not applicable
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1. male and female under 85
2. ASA 1-2
3. patients who underwent pulmonary resection due to lung cancer
Key exclusion criteria 1. supraventricular arrhythmia including atrial fibrillation or atrial flutter
2. patients with sick sinus syndrome including patients with pacemaker implantation
3. patients with severe heart failure (Class III or higher NYHA cardiac function classification)
4. patients with second or higher degree atrioventricular block
5. moderate to severe valve disease
6. patients who have experienced acute cardiovascular events, cerebrovascular events, infectious inflammation within the past 60 days
7. patients with tendency of bradycardia (resting heart rate under 55 times/min)
8. patients with systolic blood pressure less than 80 mmHg
9. patients who had been administered beta blockers before surgery
10. patients with severe bronchial asthma
11. patients who had typical honeycomb lung due to obstructive pulmonary disease (COPD stage 2 or higher) or diffuse lung disease (IP)
12. patients whose cause of atrial fibrillation was identified as electrolyte abnormality, WPW syndrome or hyperthyroidism and so on
13. patients who had been administered antiarrhythmic drugs except for digitalis before pulmonary surgery
14. patients in whom beta-blockers are contraindicated
15. chronic inflammatory diseases
16. patients with severe hepatic impairment
17. patients with severe renal impairment
18. others, patients who are judged inappropriate for this study by principle investigator
Target sample size 64

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuhiro Sakamoto
Organization Nippon Medical School
Division name Department of Anesthesiology
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Email no1-saka@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Harada
Organization Ono Pharmaceutical Co., Ltd.
Division name Clinical Development Planning 2
Zip code
Address 8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka-shi
TEL 06-6263-3902
Homepage URL
Email t.harada@ono.co.jp

Sponsor
Institute Nippon Medical School Hospital
Institute
Department

Funding Source
Organization Ono Pharmaceutical co.,ltd
Organization
Division
Category of Funding Organization Profit organization
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
2017 Year 10 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 Completed
Date of protocol fixation
2017 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 20 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
2017 Year 09 Month 29 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031896

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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