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Um-PEA N-of-1 trials in geriatric chronic pain
NCT02699281Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2015
- Primary completion
- Jul 2016
- Countries
- 1
- Sponsor
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
- Modality
- Small Molecules
- Conditions
- chronic pain
01
Overview
Phase 4, randomised, double-blind trial in chronic pain comparing Ultra-micronized Palmitoylethanolamide with Placebo (2 arms). Primary endpoint: Daily intensity of pain at 126 days. Started Oct 2015; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ultra-micronized Palmitoylethanolamide
Normast 600 mg twice a day
Placebo
Placebo twice a day
03
Who it enrols
Geriatric patients (>=65 years) with noncancer chronic pain (back, joints, or limbs) present for at least 6 months.
04
Endpoints
Primary
Daily intensity of pain
Secondary
Daily need of on-demand analgesic medications
Impact of pain on daily activities
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