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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01014247




Registration number
NCT01014247
Ethics application status
Date submitted
12/11/2009
Date registered
16/11/2009
Date last updated
3/06/2013

Titles & IDs
Public title
Influence of Moxifloxacin on QTc Interval in Healthy Subjects for Positive Control Validation
Scientific title
A Randomized, Double-blind, 2-way Crossover, Placebo-controlled Study to Investigate the Influence of a Single-dose of Moxifloxacin on the QTc Interval in Healthy Male and Female Subjects for Positive Control Validation in Selected Centers of the PATENT-1 Trial
Secondary ID [1] 0 0
2009-012363-34
Secondary ID [2] 0 0
13796
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
QTc Evaluation 0 0
Electrocardiography 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Avelox (Moxifloxacin, BAY12-8039)
Treatment: Drugs - Placebo

Active comparator: Arm 1 -

Placebo comparator: Arm 2 -


Treatment: Drugs: Avelox (Moxifloxacin, BAY12-8039)
Single dose of 400 mg

Treatment: Drugs: Placebo
Single dose of matching tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
QTc interval at 3 hours
Timepoint [1] 0 0
Day 1 of treatment period 1 and 2
Secondary outcome [1] 0 0
Safety variables
Timepoint [1] 0 0
Up to last visit of follow up
Secondary outcome [2] 0 0
Pharmacokinetic parameters
Timepoint [2] 0 0
On different time points

Eligibility
Key inclusion criteria
* Healthy volunteers
* Age 18-75 years - Normal ECG
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Abnormal ECG - Intolerance to fluorochinolones

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2010
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Hessen
Country [2] 0 0
Germany
State/province [2] 0 0
Sachsen
Country [3] 0 0
Singapore
State/province [3] 0 0
Singapore
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01014247