UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007489 |
|---|---|
| Receipt number | R000008633 |
| Scientific Title | QT/QTc evaluation and comparison study by digital ECG recorder and Digital 12 lead Holter ECG recorder with Moxifloxacin single dose on healthy Japanese volunteers. |
| Date of disclosure of the study information | 2012/03/14 |
| Last modified on | 2012/09/12 12:16:55 |
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Basic information
Public title
QT/QTc evaluation and comparison study by digital ECG recorder and Digital 12 lead Holter ECG recorder with Moxifloxacin single dose on healthy Japanese volunteers.
Acronym
Moxifloxacin on QT intervals
Scientific Title
QT/QTc evaluation and comparison study by digital ECG recorder and Digital 12 lead Holter ECG recorder with Moxifloxacin single dose on healthy Japanese volunteers.
Scientific Title:Acronym
Moxifloxacin on QT intervals
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare and evaluate the effect of Moxifloxacin on QT/QTc in Japanese healthy volunteers using digital ECG recorder and digital 12 lead Holter ECG recorder.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prove the similarity of QT/QTc data from different ECG recording methods.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Moxifloxacin 400mg
Interventions/Control_2
DHC(R) Mutivitamine (Vit B C D E P etc.)
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
Those who satisfy following conditions on screening check-ups. Body weight more than 50 kg, BMI more than 17.6, less than 26.4. Healthy volunteers with the written informed consent.
Key exclusion criteria
On screening check-ups, QTc more than 450 msec. Heart rate less than 40, more than 100. Family history of Long QT Syndrome. History of syncope or loss of consciousness. Drugs or alcohol addiction.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Matsumoto |
Organization
Sekino Clinical Pharmacology Clinic
Division name
Internal Medicine
Zip code
Address
3-28-3 Ikebukuro, Toshima-ward, Tokyo
TEL
03-5396-4530
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Sekino Clinical Pharmacology Clinic
Division name
Recruit Department
Zip code
Address
3-28-3, Ikebukuro, Toshima-ward, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Sekino Clinical Pharmacology Clinic
Institute
Department
Personal name
Funding Source
Organization
Sekino Clinical Pharmacology Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
関野臨床薬理クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 14 | 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
| 2012 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | 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
| 2012 | Year | 03 | Month | 12 | Day |
Last modified on
| 2012 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008633
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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