Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000535370
Ethics application status
Approved
Date submitted
24/09/2008
Date registered
22/10/2008
Date last updated
4/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase IV study, randomized, placebo-controlled for the evaluation of efficacy and tolerability of arginine aspartate in patients with moderate to severe fatigue
Scientific title
Phase IV study, randomized, placebo-controlled for the evaluation of efficacy and tolerability of arginine aspartate in patients with moderate to severe fatigue
Secondary ID [1] 252340 0
Not aplicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to severe fatigue 3737 0
Condition category
Condition code
Other 3913 3913 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arginine aspartate 250mg administration orally during 60 days, 2 tablets twice a day (after breakfeast and after dinner)
Intervention code [1] 3452 0
Treatment: Drugs
Comparator / control treatment
Placebo (the same substances except for arginine aspartate) administration orally during 60 days, 2 tablets twice a day (after breakfeast and after dinner)
Control group
Placebo

Outcomes
Primary outcome [1] 4811 0
Clinical evaluation measured by the Piper scale
Timepoint [1] 4811 0
Evaluation will be measured in screening - visit 1 (7 days before baseline), baseline - visit 2 (day = 0), visit 3 (day =30), visit 4 (day = 60 - end of treatment period)
Secondary outcome [1] 8118 0
Tolerability measured by patient adverse event reports (Serious and non serious adverse event). Arginine aspartate rarely presents alergic reactions or other adverse event, however every single adverse event presented during the study (81 days - screening, treatment period and follow up period) will be followed. The adverse events will be assessed by patient reports during each study visit and/or patient contact at any time. Non serious adverse events will be recorded at the Case Report Form (CRF) and serious adverse events will be recorded at a special serious adverse event report form (e.g. Council for International Organizations of Medical Sciences (CIOMS)
Timepoint [1] 8118 0
During all study - 81 days (baseline - 7 days, treatment period - 60 days and follow up period - 14 days)

Eligibility
Key inclusion criteria
Patients between 18 to 70 years old
Informed consent
Rate = or more than 4 in the Piper Scale
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnants
Depression
Organic disease

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1233 0
Brazil
State/province [1] 1233 0

Funding & Sponsors
Funding source category [1] 3917 0
Commercial sector/Industry
Name [1] 3917 0
Nikkho Zydus
Country [1] 3917 0
Brazil
Primary sponsor type
Commercial sector/Industry
Name
Nikkho Zydus
Address
Rua Jaime Perdigão 431- Rio de Janeiro
Country
Brazil
Secondary sponsor category [1] 3514 0
None
Name [1] 3514 0
Address [1] 3514 0
Country [1] 3514 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5980 0
Federal University of Sao Paulo
Ethics committee address [1] 5980 0
Ethics committee country [1] 5980 0
Brazil
Date submitted for ethics approval [1] 5980 0
Approval date [1] 5980 0
Ethics approval number [1] 5980 0

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

Contacts
Principal investigator
Name 28968 0
Address 28968 0
Country 28968 0
Phone 28968 0
Fax 28968 0
Email 28968 0
Contact person for public queries
Name 12125 0
Tatiana Ferian da Fonseca
Address 12125 0
Rua Borges Lagoa 1080- conj.101
São Paulo
Country 12125 0
Brazil
Phone 12125 0
55.11.59044454
Fax 12125 0
55.11.50837848
Email 12125 0
tatiana@newcotrials.com
Contact person for scientific queries
Name 3053 0
Tatiana Ferian da Fonseca
Address 3053 0
Rua Borges Lagoa, 1080- conj.101
São Paulo
Country 3053 0
Brazil
Phone 3053 0
55.11.59044454
Fax 3053 0
55.11.50837848
Email 3053 0
tatiana@newcotrials.com

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.