Recruiting
Phase 2

Palmitoylethanolamide

Sponsor:

Navy Medical Center San Diego

Code:

NCT06273462

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Palmitoylethanolamide 600mg twice a day

placebo

Study Details

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

Study ID

NCT06273462

Start date

Aug 5, 2024

Status verified date

Aug, 2024

Completion date

Oct 30, 2025

Anticipated

Primary completion date

Aug 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Palmitoylethanolamide

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

placebo comparator: Placebo

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

Interventions

Palmitoylethanolamide 600mg twice a day

600mg palmitoylethanolamide twice a day

placebo

visually identical placebo capsule

Primary outcome measure

  • Pain Level [ Time Frame: 4 and 8 weeks ]

Central Contacts and Locations

Central contacts

Brian McLean Pain Physician, MD

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

IRB Administrator

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

Locations

Naval Medical Center San Diego

Recruiting

San Diego, California, United States, 92118

Contacts

Naval Medical Center Institutional Review Board

619-532-9927kristina.m.umali.civ@health.mil

Principal Investigator:

Brian McLean COL, USA MC, MD

More Information

Sponsor

Navy Medical Center San Diego

Last update posted

Aug 15, 2024

Last verified

Aug, 2024

Keywords

  • chronic pain
  • supplement
  • alternative therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Navy Medical Center San Diego on 2024-08-15.