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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007489
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Sekino Clinical Pharmacology Clinic
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008633

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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