UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of efficacy and safety of landiolol hydrochloride for pulmonary resection
Title of the study (Brief title)	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	Atsuhiro Sakamoto
Organization	Nippon Medical School
Division name	Department of Anesthesiology
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Email	no1-saka@nms.ac.jp

Public contact
Name of contact person	Tomohiro Harada
Organization	Ono Pharmaceutical Co., Ltd.
Division name	Clinical Development Planning 2
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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