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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | atrial fibrillation after lung resection | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Diltiazem 90mg/day from POD 1 to POD 7
Diltiazem 60mg/day from POD 8 to POD 14 |
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Interventions/Control_2 | Lactose 0.9g/day from POD 1 to POD 7
Lactose 0.6g/day from POD 8 to POD 14 |
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Interventions/Control_3 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 124 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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Organization | Hokkaido University Graduate School of Medicine | ||||||
Division name | Department of Surgical Oncology | ||||||
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Address | |||||||
TEL | 011-706-7714 | ||||||
Homepage URL | |||||||
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 | |
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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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
Date of protocol fixation |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |