UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029348 |
|---|---|
| Receipt number | 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 11:15:04 |
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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
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
t.harada@ono.co.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031896
| 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 |
