Efficacy of Ultra-micronized Palmitoylethanolamide (Um-PEA) in Geriatric Patients With Chronic Pain
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| ClinicalTrials.gov Identifier: NCT02699281 |
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Recruitment Status :
Completed
First Posted : March 4, 2016
Last Update Posted : September 11, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Pain | Drug: ultra-micronized palmitoylethanolamide Drug: Placebo | Phase 4 |
Background: Chronic pain in the elderly is highly prevalent, often underestimated, and associated with adverse outcomes. Most available analgesic drugs are often either ineffective or not tolerated, and burdened with many side effects. Palmitoylethanolamide (PEA) is an endogenous widely distributed N-acylethanolamina involved in neuroinflammation and pain generating processes. Formulations containing ultra-micronized Palmitoylethanolamide (um-PEA) are available on the market but their effectiveness on chronic pain in highly heterogeneous geriatric patients is not clear and likely not generalizable. 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.
Methods/Design: 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. um-PEA or placebo 3-week periods will be separated by 2-week washout intervals to overcome the possible carryover effect. Pain intensity, need for on-demand analgesic medications, and impact on daily activities will be evaluated. Also, cognitively impaired patients will be eligible as long as the expression of pain can be recognized and its frequency assessed by a caregiver. Trial results will be then discussed with the patient/caregiver and the treating physician to decide whether to continue the treatment. The impact of the N-of-1 approach on the physician's management plan and confidence will be assessed. 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.
Discussion: While pursuing an ultimate clinical objective, i.e. to empirically and objectively decide the best treatment choice for an individual older patient with chronic pain, these series of geriatric N-of-1 trials on PEA will bring the Evidence Based Medicine principles into the care of patients not usually represented in conventional randomized controlled trials, and realize a patient-centered outcome approach necessary to improve appropriate prescribing in elderly patients with multimorbidity and polypharmacy.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 11 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | N-of-1 Randomised Trials to Assess the Efficacy of Ultra-micronized Palmitoylethanolamide (Um-PEA) in Geriatric Patients With Chronic Pain |
| Study Start Date : | October 2015 |
| Actual Primary Completion Date : | July 2016 |
| Actual Study Completion Date : | July 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ultra-micronized Palmitoylethanolamide
Ultra-micronized Palmitoylethanolamide 600 mg twice a day
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Drug: ultra-micronized palmitoylethanolamide
ultra-micronized palmitoylethanolamide 600 mg twice a day
Other Names:
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Placebo Comparator: Placebo
Placebo tab twice a day
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Drug: Placebo
um-PEA like placebo twice a day
Other Name: um-PEA like placebo |
- daily intensity of pain assessed using a 11-point visual numeric scale, accompanied with labels and pictures, modified from Faces Pain Scale. [ Time Frame: 126 days ]
- daily need of on-demand analgesic medications [ Time Frame: 126 days ]
- impact of pain on daily activities (short questionnaire modified from the back pain functional scale) [ Time Frame: 126 days ]The short questionnaire modified from the back pain functional scale consists of 12 items (but it can be modified to better fit to the patients). A score from 1 to 5 is assigned to each item.
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| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- cancer-related pain
- clear ischemic pathogenesis for pain (e.g. claudicatio intermittens or critical limb ischemia)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699281
| Italy | |
| Geriatric Unit, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico | |
| Milano, Italy, 20122 | |
| Principal Investigator: | Maura Marcucci, MD, MSc | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Responsible Party: | Maura Marcucci, MD, MSc, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| ClinicalTrials.gov Identifier: | NCT02699281 |
| Other Study ID Numbers: |
Nof1-PEA |
| First Posted: | March 4, 2016 Key Record Dates |
| Last Update Posted: | September 11, 2019 |
| Last Verified: | September 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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Chronic Pain Pain Neurologic Manifestations Palmidrol Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Anti-Inflammatory Agents Antirheumatic Agents Antiviral Agents Anti-Infective Agents Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |