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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000001691
Receipt No. R000002035
Scientific Title Phase II study of prophylactic oral administration of diltiazem for atrial fibrillation after lung resection
Date of disclosure of the study information 2009/02/06
Last modified on 2010/09/07

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Basic information
Public title Phase II study of prophylactic oral administration of diltiazem for atrial fibrillation after lung resection
Acronym Prophylactic administration of diltiazem for atrial fibrillation after lung resection
Scientific Title Phase II study of prophylactic oral administration of diltiazem for atrial fibrillation after lung resection
Scientific Title:Acronym Prophylactic administration of diltiazem for atrial fibrillation after lung resection
Region
Japan

Condition
Condition atrial fibrillation after lung resection
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Efficacy of prophylactic oral administration of diltiazem for atrial fibrillation after lung resection (inhibition ratio of onset)
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Incidence of atrial fibrillation after lung resection
Key secondary outcomes Degree and frequency of adverse event (hypotension, bradycardia, etc.)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Diltiazem 90mg/day from POD 1 to POD 7
Diltiazem 60mg/day from POD 8 to POD 14
Interventions/Control_2 Lactose 0.9g/day from POD 1 to POD 7
Lactose 0.6g/day from POD 8 to POD 14
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
45 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria primary lung cancer
lobectomy or pneumonectomy
PS 0-2
be able to take something by mouth
WBC >3000
Hb >9.5
Plt >100000
T-bil <1.5
AST, ALT <80
Cre <1.5
PaO2 >65 or SpO2 >92
informed consent
Key exclusion criteria unstable angina pectoris, myocardial infarction or heart failure with in 3 months
uncontrolled diabetes or hypertension
active infection
gastrointestinal bleeding
diarrhea
ileus
chronic Af
already taking diltiazem or other calcium blocker
AV block more than 2nd degree
sick sinus syndrome
past history of severe allergy
uncontrolled pleural effusion, ascites or pericardial fluid
in pregnancy
Target sample size 124

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Kondo
Organization Hokkaido University Hospital
Division name Surgery II
Zip code
Address North 14 West 5, Kita-ku, Sapporo, Hokkaido
TEL 011-716-1161
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Hida
Organization Hokkaido University Graduate School of Medicine
Division name Department of Surgical Oncology
Zip code
Address
TEL 011-706-7714
Homepage URL
Email

Sponsor
Institute Department of Surgical Oncology, Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Surgical Oncology, Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Teine Keijinkai Hospital
Minami Sanjo Hospital
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
2009 Year 02 Month 06 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 Enrolling by invitation
Date of protocol fixation
2008 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 02 Month 06 Day
Last modified on
2010 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002035

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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