Palmitoylethanolamide for Chronic Inflammatory Pain Conditions

Part of paid clinical trials in San Diego, California.

Sponsor
Navy Medical Center San Diego
Study ID
NCT06273462
Phase
PHASE2
Status
Recruiting

Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Palmitoylethanolamide 600mg twice a day — DRUG
    600mg palmitoylethanolamide twice a day
  • placebo — OTHER
    visually identical placebo capsule

Study Details

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.

Key Dates

Start date
Aug 5, 2024
Status verified
Aug 2024
Primary completion
Aug 1, 2025
Completion
Oct 30, 2025

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Pain Level [ Time Frame: 4 and 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Naval Medical Center San DiegoSan DiegoCalifornia92118
Naval Medical Center Institutional Review Board
619-532-9927
Brian McLean COL, USA MC, MD (PRINCIPAL_INVESTIGATOR)

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