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Trial registered on ANZCTR


Registration number
ACTRN12609000702213
Ethics application status
Approved
Date submitted
18/05/2009
Date registered
13/08/2009
Date last updated
10/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Study to compare the effects of taking 2.5mg of the antihstamine, Loratidine, four times a day with taking 10mg of Loratidine once a day in healthy volunteers
Scientific title
Maxiclear PD Study: A Double Blind, Randomised, Cross-over Trial to Compare the Pharmacodynamic Effects of Loratadine 2. 5 mg Four Times a Day with Loratadine 10 mg Once Daily in healthy volunteers.
Secondary ID [1] 872 0
NTX/09/06/052
Health and Disability Ethics Committees, Northern X Regional Ethics Committee, New Zealand
Universal Trial Number (UTN)
Trial acronym
Maxiclear PD Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic rhinitis and relief of other allergic symptoms 4796 0
Condition category
Condition code
Inflammatory and Immune System 237141 237141 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Loratadine 2.5 mg tablet four times a day orally for 72 hours. Participants who are on the this dose regimen in the first study phase will swap to the other dose regimen (loratadine 10 mg once daily) in the second cross-over study phase. Washout is at least 10 days between these two study phases.
Intervention code [1] 4571 0
Treatment: Drugs
Comparator / control treatment
Loratadine 10 mg once a day orally for 72 hours. Washout is at least 10 days between two study phases. Placebo tablets containing lactose will be used to match the different dosing frequency that is for the four doses per day, one dose is on loratadine 10 mg tablet and all the other three doses are on placebo tablets. Placebo tablets will alos be taken orally for 72 hours.
Control group
Active

Outcomes
Primary outcome [1] 237960 0
The area under the curve (AUC) of the wheal induced by a skin prick test of a standard dose of histamine 72 hours after the first dose
Timepoint [1] 237960 0
72 hours after the first dose
Secondary outcome [1] 242064 0
Adverse events will be assessed and determined up to 7 days after the last dose.These adverse sevents reporting will include self-report on participant follow up notebook and clinician assessment during each study visit.
Timepoint [1] 242064 0
Up to 7 days after the last dose

Eligibility
Key inclusion criteria
Healthy volunteers, males and females aged 18-50 years.
Females must be sterile or using adequate contraception.
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who have any concomitant medications currently, or in the 7 days prior to the start of the each study phase. The only exception are oral contraceptives, ibuprofen and paracetamol.
Suffering from any other diseases or condition which, in the opinion of the investigator, means that it would not be in the participant's best interests to participate in this study.

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)
Participants who are eligible, will be randomised to receieve loratadine tablets as two different dose regimens (loratadine 10 mg once daily, loratadine 2.5 mg four times daily) in two sequences. The randomisation code will specify which dose regimen the participant will receive during the first study phase and which during the second cross-over study phase. This randomization code will be sealed in a opaque envelope and allow investigators to have the access of information that the participant is on which treatment in case of any emergency. Another set of this randomization code list is hold by the biostatistician who generates this list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence will be generated by a computer and the randomisation code will specify which dose regimen the participant will receive during the first study phase and which during the second cross-over study phase.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Double Dummy-Placebos will be used for the dose regimen of loratadine 10 mg once daily to match the different dosing frequency with loratadine 2.5 mg four times daily.
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1777 0
New Zealand
State/province [1] 1777 0
Auckland
Country [2] 1778 0
New Zealand
State/province [2] 1778 0

Funding & Sponsors
Funding source category [1] 4967 0
Commercial sector/Industry
Name [1] 4967 0
AFT Pharmaceuticals Ltd
Address [1] 4967 0
Level 2, 9 Anzac Street,
PO Box 33 203
Takapuna, Auckland
Country [1] 4967 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
AFT Pharmaceuticals Ltd
Address
Level 2, 9 Anzac Street,
PO Box 33 203
Takapuna, Auckland
Country
New Zealand
Secondary sponsor category [1] 4492 0
None
Name [1] 4492 0
Address [1] 4492 0
Country [1] 4492 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7070 0
Health and Disability Ethics Committee, Northern X Regional Ethics Committee
Ethics committee address [1] 7070 0
Ethics committee country [1] 7070 0
New Zealand
Date submitted for ethics approval [1] 7070 0
Approval date [1] 7070 0
03/08/2009
Ethics approval number [1] 7070 0

Summary
Brief summary
Loratadine is usually given as a 10 mg dose once daily for the treatment of allergic condictions. However, based on pharmacokinetic principles it is likely that divided daily dosing such as 2.5 mg four times a day will also produce a similar effect on histamine effect compared with loratadine 10 mg once daily. This would enable smaller doses of loratadine to be combined with shorter acting agents such as phenylephrine.
Trial website
Trial related presentations / publications
This study was not published yet
Public notes

Contacts
Principal investigator
Name 29613 0
Dr Christian Schwabe
Address 29613 0
Auckland Clinical Studies, Ground Floor, ECOM House, 3 Ferncroft St, Grafton, Auckland 1150, New Zealand
Country 29613 0
New Zealand
Phone 29613 0
+ 09-373 3474
Fax 29613 0
Email 29613 0
christian@clinicalstudies.co.nz
Contact person for public queries
Name 12860 0
Dr Jennifer Zhang
Address 12860 0
Level 2, 9 Anzac Street,
PO Box 33 203
Takapuna, Auckland
Country 12860 0
New Zealand
Phone 12860 0
+ 64 9 488 0232
Fax 12860 0
+ 64 9 488 0234
Email 12860 0
jennifer@aftpharm.com
Contact person for scientific queries
Name 3788 0
Dr Hartley Atkinson
Address 3788 0
Level 2, 9 Anzac Street,
PO Box 33 203
Takapuna, Auckland
Country 3788 0
New Zealand
Phone 3788 0
+ 64 9 488 0232
Fax 3788 0
+ 64 9 488 0234
Email 3788 0
hartley@aftpharm.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary