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Trial registered on ANZCTR


Registration number
ACTRN12615000149561
Ethics application status
Approved
Date submitted
2/02/2015
Date registered
17/02/2015
Date last updated
19/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind, randomised, placebo-controlled study on the safety and efficacy of Palmitoylethanolamide (PEA) for the management of mild to moderate osteoarthritis symptoms.
Scientific title
A double-blind, randomised, placebo-controlled study on the safety and efficacy of Palmitoylethanolamide (PEA) for management of mild to moderate osteoarthritis symptoms
Secondary ID [1] 286090 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 294092 0
Condition category
Condition code
Musculoskeletal 294400 294400 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - Palmitoylethanolamide (PEA) oral dose (tablet) of 300mg per day for 8 weeks.

Arm 2 - Palmitoylethanolamide (PEA) oral dose (tablet) of 600mg per day for 8 weeks.

The participants will be monitored for adherence through telephone and email contact throughout the treatment phase. All unused product is returned at completion of the study.
Intervention code [1] 291083 0
Treatment: Drugs
Comparator / control treatment
Control group - Identical capsules to interventions (colour and size) containing maltadextrin only.
Control group
Placebo

Outcomes
Primary outcome [1] 294195 0
Assess the effect of the Investigational Product on the symptoms of mild to moderate Osteoarthritis. This is measured by the WOMAC Questionnaire, SF-36, and Vas Pain Scale.
Timepoint [1] 294195 0
Baseline, 4 weeks and 8 weeks
Secondary outcome [1] 312732 0
Assess the effect of the Investigational Product on paracetamol usage in subjects with mild to moderate osteoarthritis. This is measured by participants keeping a daily record of paracetamol use.
Timepoint [1] 312732 0
Baseline, 4 weeks and 8 weeks
Secondary outcome [2] 312870 0
To assess the safety of the intervention. This is done by combination of pathology tests for RBC, WBC, electrolyte / liver function tests as well as participant reporting of any adverse reactions while in treatment phase.
Timepoint [2] 312870 0
Baseline, week 4, and week 8.

Eligibility
Key inclusion criteria
Inclusion Criteria

Medically diagnosed Osteoarthritis
VAS Pain greater than 4
Not using daily prescribed Osteoarthritis medication
Males and females 40-75 years of age
BMI between 18.5 - 35
Minimum age
40 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

All other forms of arthritis and other auto-immune issues
Significant joint injury within last 6 months
Women that are pregnant or breast feeding
Uncontrolled diagnosed serious health conditions such as diabetes, high cholesterol, hypertension, osteoporosis or have digestive disease(s).
Known hypersensitivity to herbal drugs/nutritional supplement/ foods
Have started used a drug/natural therapy for Osteoarthritis within the last 30 days – Including Fish oil/ Omega 3 supplement
Receiving/ prescribed coumandin (Warfarin) or other anticoagulation therapy
Current or history of chronic alcohol and/or drug abuse
History of cerebrovascular accident, stroke, or transient ischemia.
Major depressive disorders, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.
Currently using other investigational product(s).
Have experienced unintended weight loss of more than 15% of body weight in last 6 months.
Active substance abuse (alcohol or drug dependency).



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)
Approximately 120 male and female subjects aged between 40-75 years of age will be recruited from databases and public media outlets. Following preliminary screening via telephone, potential subjects will attend the clinic for an information session and will be requested to provide their consent for inclusion in the trial. Consenting potential subjects will undergo a medical assessment including lifestyle, current medications, physical assessment and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study.

The trial product is sent to already randomised and in numbered containers (001-120) so administering staff are blinded to allocation.

Once enrolled in the trial, participants will be randomly allocated to either the placebo comparator group (n=60) or the active intervention group (n=60). Enrolled participants will be allocated a sequential number from 0001 to 0100 determined by the order in which they are enrolled. Subjects will be allocated a (randomised) TPC that corresponds with their allocation number; for example, participant 0034 will receive TPC 0034.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation code used to identify TPCs is a sequential number (0001 to 00120) generated by the Random Allocation 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)
Safety/efficacy
Statistical methods / analysis
Sample size
Based on a 10mm improvement in pain (SD=15mm) compared to placebo as measured by the pain outcomes section on the WOMAC, a total of 40 patients in each arm at final follow up is required for an 80% power.

Efficacy
The primary endpoint (WOMAC questionnaire responses at baseline, 4 and 8 weeks) will be analysed using an analysis of covariance, with baseline (pre-treatment) questionnaire scores as a covariate. Treatment arm will be represented by a factor n the analysis of covariance. Least squares means will be tabulated. Strict control of the family wise type one error rate for multiple time points will be maintained using Holm’s adjustment.


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 in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 290675 0
Commercial sector/Industry
Name [1] 290675 0
Gencor Pacific
Address [1] 290675 0
21-E, Elegance Court
Hillgrove Village
Discovery Bay
Hong Kong
Country [1] 290675 0
Hong Kong
Primary sponsor type
Commercial sector/Industry
Name
Integrated Health Group Pty. Ltd.
Address
188 James Street
New Farm, Brisbane, 4005
Qld Australia
Country
Australia
Secondary sponsor category [1] 289368 0
None
Name [1] 289368 0
Address [1] 289368 0
Country [1] 289368 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292305 0
Queensland Clinical Trials Network
Ethics committee address [1] 292305 0
Level 3 88 Jephson Street
Toowong Brisbane
QLD 4066
Ethics committee country [1] 292305 0
Australia
Date submitted for ethics approval [1] 292305 0
02/02/2015
Approval date [1] 292305 0
05/05/2015
Ethics approval number [1] 292305 0
HREC2014003

Summary
Brief summary
Palmitoylethanolamide (PEA), also known as N-(2-hydroxyethyl) hexadecanamide or N-(2-hydroxyethyl)-palmitamide is an endogenous saturated fatty acid derivative.

This study aims to investigate the effects of PEA on pain and quality of life in subjects with mild to moderate osteoarthritis and is designed with two active group arms and one placebo arm. The two active group dosages of 300mg and 600mg per day of PEA are similar to dosages used in other studies. The primary outcome measure is the WOMAC OA Index questionnaire. The participant group includes otherwise healthy men and women aged between 40 and 65 years.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54574 0
Dr Elizabeth Steels
Address 54574 0
Integrated Health Group Clinic 188 James Street New Farm, QLD 4005
Country 54574 0
Australia
Phone 54574 0
+61431003929
Fax 54574 0
Email 54574 0
research@integratedhealthgroup.com.au
Contact person for public queries
Name 54575 0
Dr Elizabeth Steels
Address 54575 0
Integrated Health Group Clinic, 188 James Street New Farm, QLD 4005
Country 54575 0
Australia
Phone 54575 0
+61431003929
Fax 54575 0
Email 54575 0
elizabeth.steels@integratedhealthgroup.com.au
Contact person for scientific queries
Name 54576 0
Dr Elizabeth Steels
Address 54576 0
Integrated Health Group Clinic 188 James Street New Farm, QLD 4005
Country 54576 0
Australia
Phone 54576 0
+61431003929
Fax 54576 0
Email 54576 0
elizabeth.steels@integratedhealthgroup.com.au

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