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Trial registered on ANZCTR


Registration number
ACTRN12618000294257
Ethics application status
Approved
Date submitted
13/02/2018
Date registered
27/02/2018
Date last updated
24/04/2020
Date data sharing statement initially provided
6/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind randomised controlled study to evaluate the effectiveness of orally-dosed Palmitoylethanolamide (PEA) compared to ibuprofen for reducing pain severity
and duration of headaches in healthy participants aged 18 years and older.
Scientific title
A double-blind randomised controlled study to evaluate the effectiveness of orallydosed Palmitoylethanolamide (PEA) compared to ibuprofen for reducing pain severity
and duration of headaches in healthy participants aged 18 years and older.
Secondary ID [1] 294043 0
PEA-HED17
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Headache 306587 0
Condition category
Condition code
Alternative and Complementary Medicine 305681 305681 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Palmitoylethanolamide (PEA) can be sold as a dietary supplement for medical purposes under FSANZ (Food Standards Australia and NZ).

PEA will be taken as a single 525mg dose in capsule form with water.

Ibuprofen will be dosed at the manufacturers recommendation (400 mg).

Approximately 80 adult male and female participants aged between 18 years and older will be recruited from databases and public media outlets. Following preliminary screening via telephone, if eligible, potential participants will attend the clinic for an information session and will be requested to provide their consent for inclusion in the trial. Consenting potential participants will undergo a health assessment including lifestyle, current medications, physical assessment (weight and height) and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study. A standardised questionnaire will be administered to assess participants lifestyle including questions about their: age, weight, height, partner status, level of physical activity, alcohol and cigarette consumption, and work status. Participants will be enrolled in the study for a maximum of 4 months, with participation concluding once 5 headache events have been recorded.

Upon the onset of headache symptoms, participants will record the time and date of the
occurrence and score the perceived headache pain using a Visual Analog Score (VAS)
system in a diary provided. Participants will also record gastrointestinal (GIT) tolerance.

Participants will immediately supplement with a single dose (525 mg) of PEA with water or
ibuprofen (400 mg) with water. After supplementation, participants will score the headache
pain (using the VAS) and GIT tolerance every 30 minutes until the headache subsides, or
until 4 hours has passed from headache onset (whichever occurs first). This will provide pain
and frequency data for analysis. Data on the type (e.g. neural, hormonal, musculoskeletal)
for subgroup analysis will also be collected.

If a headache / pain occurs and does not subside within two hours, rescue medication
(paracetamol) may be used. Any rescue medication use will be noted in the diary and the
participant will still score the headache pain using the VAS until the headache subsides, or a
further 2 hours has passed since rescue medication use (4 hours from headache onset).

Participants will be given enough product for 5 episodes of pain and therefore may provide
data for more than one pain event.

During the trial period, participants will be followed up every 4 weeks via phone calls until all
5 episodes have occurred or their involvement in the study stops (maximum 4 months).
Intervention code [1] 300314 0
Treatment: Drugs
Comparator / control treatment
Ibuprofen comparator will be packaged identically to the active PEA treatment and dosed in the same way to the active.
Control group
Placebo

Outcomes
Primary outcome [1] 304774 0
headache pain/severity as assessed by VAS for pain scale
Timepoint [1] 304774 0
Baseline and every 30 minutes during headache episode with final recording being the primary endpoint
Secondary outcome [1] 343137 0
headache duration assessed by recording duration in headache diary
Timepoint [1] 343137 0
Every 30 minutes during headache episode
Secondary outcome [2] 343138 0
pain relief medication use as assed by headache diary
Timepoint [2] 343138 0
Every 30 minutes during headache episode

Eligibility
Key inclusion criteria
Adults aged over 18
No history or evidence of clinically significant medical conditions including, but not
limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine
(including uncontrolled diabetes or thyroid disease) or haematological abnormalities
that are uncontrolled.
Participant’s full agreement and ability to consent to participation in the study
At least 2 headache episodes per month
Access to a computer or smartphone for completing online questionnaires and
events.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Use of long-term medication (unless for controlled medical
condition as above)
Malignancy or treatment for malignancy within the previous 2 years
Pregnant or lactating women
Females not taking a prescribed form of contraception (i.e. oral
contraception pill, birth control implant e.g. implanon)
Chronic past and/or current alcohol use (>14 alcoholic drinks
week)
Smokers
Allergic or hypersensitive to any of the ingredients in the active or
ibuprofen formula

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)
The potential participants are screened by the investigator for inclusion in the study. The eligible participants are enrolled by investigator and provided with a "Numbered Container" that is identical to all other containers and contains the same information on the label, except for the number. The investigator is blinded to the product randomized with the
numbered containers labelled prior to delivery to investigational site. Product allocated as participants are enrolled in sequential order
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomized software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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 in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 298668 0
Commercial sector/Industry
Name [1] 298668 0
Gencor Pacific
Address [1] 298668 0
21-E,Elegance
Hillgrove Village
Discovery Bay 999077
Hong Kong

Country [1] 298668 0
Hong Kong
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
3B/76 Doggett St
Newstead, QLD, 4006
Country
Australia
Secondary sponsor category [1] 297836 0
Commercial sector/Industry
Name [1] 297836 0
Gencor Pacific
Address [1] 297836 0
21-E,Elegance
Hillgrove Village
Discovery Bay 999077
Hong Kong
Country [1] 297836 0
Hong Kong
Secondary sponsor category [2] 297917 0
Commercial sector/Industry
Name [2] 297917 0
Pharmako Biotechnologies Pty Ltd
Address [2] 297917 0
36 Campbell Ave, Cromer NSW 2099
Country [2] 297917 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299622 0
BellBerry Limited
Ethics committee address [1] 299622 0
129 Glen Osmond Road
Eastwood South Australia 5063
Ethics committee country [1] 299622 0
Australia
Date submitted for ethics approval [1] 299622 0
01/06/2017
Approval date [1] 299622 0
30/09/2018
Ethics approval number [1] 299622 0

Summary
Brief summary
A double-blind randomised controlled study to evaluate the effectiveness of orally-dosed Palmitoylethanolamide (PEA) compared to ibuprofen for reducing pain severity
and duration of headaches in healthy participants aged 18 years and older
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81066 0
Dr David Briskey
Address 81066 0
RDC GLOBAL Pty Ltd
3B/76 Doggett Street, Newstead, QLD, 4006
Country 81066 0
Australia
Phone 81066 0
+61 421 784 077
Fax 81066 0
Email 81066 0
d.briskey@uq.edu.au
Contact person for public queries
Name 81067 0
Ms Amanda Rao
Address 81067 0
RDC GLOBAL Pty Ltd
3B/76 Doggett Street, Newstead, QLD, 4006
Country 81067 0
Australia
Phone 81067 0
+61 414 488 559
Fax 81067 0
Email 81067 0
amanda@rdcglobal.com.au
Contact person for scientific queries
Name 81068 0
Ms Amanda Rao
Address 81068 0
RDC GLOBAL Pty Ltd
3B/76 Doggett Street, Newstead, QLD, 4006
Country 81068 0
Australia
Phone 81068 0
+61 414 488 559
Fax 81068 0
Email 81068 0
amanda@rdcglobal.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD will be shared
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 125 0
Ethical approval
Citation [1] 125 0
Link [1] 125 0
Email [1] 125 0
Other [1] 125 0
Type [2] 2048 0
Ethical approval
Citation [2] 2048 0
Link [2] 2048 0
Email [2] 2048 0
Other [2] 2048 0
Ethics amendment 1
Type [3] 2049 0
Ethical approval
Citation [3] 2049 0
Link [3] 2049 0
Email [3] 2049 0
Other [3] 2049 0
Ethics amendment 2
Type [4] 2050 0
Ethical approval
Citation [4] 2050 0
Link [4] 2050 0
Email [4] 2050 0
Other [4] 2050 0
Amendment 3
Summary results
No Results