Palmitoylethanolamide for Chronic Inflammatory Pain Conditions

NCT06273462 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: NMCSD.2024.0006
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate if a supplement called palmitoylethanolamide (PEA) is effective in reducing the pain in patients with chronic inflammatory pain conditions. The main question the trial aims to answer is if PEA works better at treating a patients pain and improving their function better than a placebo. Participants will be divided into two equal groups and asked to take either PEA or a placebo for 8 weeks.

Conditions

Chronic Pain

Keywords

chronic pain; supplement; alternative therapy

Outcome Measures

Primary Outcomes (1)

• Pain Level

  Pain level will be assessed using the Defense and Veterans Pain Rating Scale (DVPRS) Where the minimum value is 0 indicating no pain and the maximum value is 10 indicating worst possible pain

  4 and 8 weeks

Secondary Outcomes (3)

• Pain interference and function

  4 and 8 weeks

• Pain Catastrophizing Scale (PCS)

  4 and 8 weeks

• Patient Reported Outcome Measurement Information System (PROMIS) (Pain interference, Social satisfaction; Physical function)

  4 and 8 Weeks

Study Arms (2)

Palmitoylethanolamide

EXPERIMENTAL

Participants randomized to the experimental arm will receive the supplement Palmitoylethanolamide (PEA) at a dose of 600mg twice a day

Drug: Palmitoylethanolamide 600mg twice a day

Placebo

PLACEBO COMPARATOR

Participants randomized to the placebo arm will receive a visually identical placebo capsule

Other: placebo

Interventions

Palmitoylethanolamide 600mg twice a day DRUG

600mg palmitoylethanolamide twice a day

Also known as: PEA

Palmitoylethanolamide

placebo OTHER

visually identical placebo capsule

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Inflammatory Pain of greater than 3 months duration and greater than or equal to 5/10 intensity that has not responded to other conservative therapies such as rest, ice, compression or other oral medications.

You may not qualify if:

• Severe allergy to any specific food component such as nut, egg or soy

Sponsors & Collaborators

• Navy Medical Center San Diego: lead

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92118, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

palmidrol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Brian McLean Pain Physician, MD

CONTACT

619-532-8495; brian.c.mclean.mil@health.mil

IRB Administrator

CONTACT

619-532-9083; kristina.m.umali.civ@health.mil

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blinded, patients will receive visually identical capsules from research pharmacist with study label indicating PEA vs Placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Prospective Randomize Double Blind Placebo Controlled study comparing the supplement palmitoylethanolamide (PEA) to a visually identical placebo

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 22, 2024
• Study Start: August 5, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 30, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

US (1)