Efficacy of Ultra-micronized Palmitoylethanolamide (Um-PEA) in Geriatric Patients With Chronic Pain
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico