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The Effect of Palmitylethanolamide on Central and Peripheral Sensitization After Heat-induced Hyperalgesia

NCT04662827 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-11-01

No results posted yet for this study

Summary

This planned study is based on a randomized, placebo-controlled cross-over design.

Palmityhlethanolamide (PEA) is an endogenous fatty acid amide from the group of N-Acetylethanolamides, which analgesic, anti-inflammatory and neuroprotective effects can be attributed to this. In clinical studies, PEA has mainly been used as an adjuvant in pain therapy. The previous data show clinical efficacy without conclusions that can be drawn about the underlying mechanisms - these have not yet been investigated in a human experiment.

The planned study, which demonstrates the mode of action of PEA using an established pain model on healthy volunteers, will help to assign the efficacy to peripheral or central nervous systems. These mechanisms allow to establish mechanism-oriented therapy approaches. These findings are essential for a better understanding of the clinical efficacy and to evaluate the correct fields of application.

Conditions

  • Pain, Chronic
  • Pain, Acute
  • Central Sensitisation
  • Neuroinflammatory Response

Interventions

DIETARY_SUPPLEMENT

Palmithylethanolamid

PEA 3x/d

OTHER

placebo

placebo 3x/d

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • helmar Boremann-cimenti · Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria. [email protected]

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-09
Primary Completion
2020-09-16
Completion
2020-09-16

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04662827 on ClinicalTrials.gov