NCT02699281

Brief Summary

Investigators planned to adopt the N-of-1 trial approach to objectively test the effectiveness of ultra-micronized PEA at an individual level in our older outpatients. 65 years old or older persons referring to the Geriatric Unit of the Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico of Milan complaining of noncancer chronic pain of any origin will be eligible. Each trial will be a placebo-controlled randomized crossover trial including two um-PEA (600 mg twice a day) and placebo treatment pairs. Investigators will secondarily meta-analyse the performed N-of-1 trials to obtain an estimate of the average effect of um-PEA compared with placebo using a frequentist and Bayesian approach.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_4 chronic-pain

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_4 chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

February 21, 2016

Last Update Submit

September 10, 2019

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • daily intensity of pain assessed using a 11-point visual numeric scale, accompanied with labels and pictures, modified from Faces Pain Scale.

    126 days

Secondary Outcomes (2)

  • daily need of on-demand analgesic medications

    126 days

  • impact of pain on daily activities (short questionnaire modified from the back pain functional scale)

    126 days

Study Arms (2)

Ultra-micronized Palmitoylethanolamide

EXPERIMENTAL

Ultra-micronized Palmitoylethanolamide 600 mg twice a day

Drug: ultra-micronized palmitoylethanolamide

Placebo

PLACEBO COMPARATOR

Placebo tab twice a day

Drug: Placebo

Interventions

ultra-micronized palmitoylethanolamideDRUG

ultra-micronized palmitoylethanolamide 600 mg twice a day

Also known as: um-PEA, Normast
Ultra-micronized Palmitoylethanolamide
PlaceboDRUG

um-PEA like placebo twice a day

Also known as: um-PEA like placebo
Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Pain is located at the back (any level) and/or at the joints and/or at the limbs.
  • The pain is chronic, i.e. it has been present for at least 6 months, even if with fluctuations.
  • The pain is attributable to one or more of the following conditions: osteoarthritis/osteoarthrosis; spondylosis; radiculopathy; diabetic peripheral neuropathy; post-herpetic neuralgia; chronic idiopathic axonal polyneuropathy; fibromyalgia; or pain of uncertain origin or idiopathic, as long as it has had and it is expected to have a chronic nature, even if with spontaneous fluctuations.

You may not qualify if:

  • cancer-related pain
  • clear ischemic pathogenesis for pain (e.g. claudicatio intermittens or critical limb ischemia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Unit, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (2)

  • Germini F, Coerezza A, Andreinetti L, Nobili A, Rossi PD, Mari D, Guyatt G, Marcucci M. N-of-1 Randomized Trials of Ultra-Micronized Palmitoylethanolamide in Older Patients with Chronic Pain. Drugs Aging. 2017 Dec;34(12):941-952. doi: 10.1007/s40266-017-0506-2.

    PMID: 29210011DERIVED

  • Marcucci M, Germini F, Coerezza A, Andreinetti L, Bellintani L, Nobili A, Rossi PD, Mari D. Efficacy of ultra-micronized palmitoylethanolamide (um-PEA) in geriatric patients with chronic pain: study protocol for a series of N-of-1 randomized trials. Trials. 2016 Jul 29;17:369. doi: 10.1186/s13063-016-1496-9.

    PMID: 27473188DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maura Marcucci, MD, MSc

    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

February 21, 2016

First Posted

March 4, 2016

Study Start

October 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

September 11, 2019

Record last verified: 2019-09

Locations

IT(1)