UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001691 |
|---|---|
| Receipt number | 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 21:46:27 |
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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
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
Sponsor or person
Institute
Department of Surgical Oncology, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002035
| 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 |
