Clinical trial NCT02032927: Treatment of Chronic Pain From Osteoarthritis
Official title: A COMPARATIVE STUDY BETWEEN TWO PHARMACOLOGICAL ASSOCIATIONS OXYCODONE/NALOXONE AND CODEINE / PARACETAMOL IN TREATMENT OF MODERATE-SEVERE CHRONIC PAIN DUE TO OSTEOARTHRITIS OF KNEE AND/OR HIP
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chronic Pain
Keywords: osteoarthritis
pain
opioids
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoarthritis is a common joint disorder in the elder population.The current treatment options include both a non-pharmacological approach (physiokinesitherapy, diet) or if this fails, a pharmacological approach that relies in the first instance on drugs such as paracetamol, non-steroidal anti-inflammatory (including inhibitors of cyclo-oxygenase). However, the use of these drugs is limited, by the roof effect concerning analgesia, and by the potential side effects. When pharmacological treatments with non-opioid medications fail, and a moderate-to-severe pain reduces the quality of life of the patient, international guidelines suggest the use of opioid drugs.

Detailed description: The WHO analgesic ladder, even with its limitations, is widely used to guide the beginning of opioid therapy in chronic pain. According to this approach the choice of drug is based on the intensity of pain reported by the patient; belong to the first step acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), and if these drugs fail it is planned to introduce a weak opioid (tramadol, codeine) alone or in combination.

The association codeine-paracetamol, one of the most widely used drug combinations in the treatment of moderate pain from osteoarthritis, demonstrated analgesic efficacy superior only to paracetamol in the short term; however, its use was less effective in the long term and worsen by multiple side effects, especially gastrointestinal with results in poor adherence to the therapy.

Lately, the international guidelines on the treatment of chronic pain in cancer have suggested the possibility of moving, in case of inadequate efficacy of paracetamol and / or NSAIDs, directly to the third step, using a low dose of a strong opioid.

The side effects associated with the use of opioids in the treatment of chronic pain, such as itching, side effects of gastrointestinal and central nervous system effects (drowsiness, giddiness), often necessitate dose reduction (thus compromising the analgesic effect), with often resulting in discontinuation of treatment.

A recent strategy to face the underlying cause of opioid-induced constipation (OIC) is the oral administration of an antagonist of opioid receptor that acts specifically and locally at the level of the gastrointestinal tract. This prevents or minimizes gastrointestinal side effects but does not affect the central analgesic effect of the opioid thank to the low bioavailability of the antagonist.

A recent review on the effects of chronic pain on cognitive function of patients describes a series of clinical evidence suggestive of a intellectual impairment predominantly associated with a significant psychomotor slowing.

An interesting corollary of the problematic pain-cognition is represented by the possible neuropsychological side effect due to teh use of opioid drugs in the treatment of chronic pain.

The objective of the research becomes to determinate how much the analgesic relief, derived from the assumption of opioid drugs, can lead to an improvement in cognitive function without the possible side effects of the drugs themselves.

Eligibility criteria: Inclusion Criteria:

* Subjects over the age of 60 years old
* Individuals with a primary diagnosis of osteoarthritis
* Subject that are able to understand the purpose of the study and that have signed a written informed consent
* Subjects that are able to take prescribed therapies, understand and complete the questionnaires and forms

Exclusion Criteria:

* Subject with history of hypersensitivity to oxycodone, naloxone , codeine , acetaminophen, ibuprofen, and the other ingredients in the formulations studied
* Subjects with known structural alterations in the gastrointestinal tract
* Subjects with secondary osteoarthritis
* Subjects with history of abuse of alcohol and / or drugs
* Subjects with history of abuse opioids.
* Patients suffering from rheumatoid arthritis
* Patients with evidence of medical or surgical unstable
* Patients with current or previous history of epilepsy
* Patients treated with anti-depressive action on the central nervous system which in the opinion of the investigator may result in additive effects with the drugs under study.
* Subjects with renal and / or hepatic impairment severe
* Subjects with a history of depression or other psychiatric condition that, in the opinion of the investigator might interfere with the study participation
* Individuals with cognitive impairment

Primary outcomes:
measure: Evaluate differences in terms of efficacy and tolerability between two pharmaceutical protocols in patients with chronic pain due to osteoarthritis.
timeFrame: 15 days from the enrolment
Secondary outcomes:
measure: Evaluate the differences between the two drug protocols, in terms of quality of life, by using of the SF-12 questionnaire.
timeFrame: 3 months from the enrollment
measure: Evaluation of the differences between the two drug protocols, in the scores obtained in the two sections, functionality and rigidity of the WOMAC questionnaire.
timeFrame: 3 months from the enrollment
measure: The evaluation of the attentive functions (selective and divided attention) and of eye-manual coordination and of psycho-motor speed will be performed trough Trail Making Test (Reitan, 1944) to all patients enrolled for the project.
timeFrame: 3 months from the enrollment
Other outcomes:
Locations:
city: Casorate Primo
country: Italy
facility: Azienda Ospedaliera della Provincia di Pavia - Ospedale "Carlo Mira" - U.O. Medicina Interna - Servizio di Anestesia e Rianimazione - Ambulatorio di Terapia del dolore
city: Cremona
country: Italy
facility: Azienda Istituti Ospitalieri di Cremona, Presidio Ospedaliero di Cremona - U.O. di Anestesia, Analgesia e Medicina Perioperatoria
city: Lodi
country: Italy
facility: Azienda Ospedaliera della provincia di Lodi Dipartimento emergenza urgenza
city: Milano
country: Italy
facility: Azienda Ospedaliera Istituto Ortopedico Gaetano Pini - U.O.C. Anestesia e Rianimazione
city: Mortara
country: Italy
facility: Azienda Ospedaliera della Provincia di Pavia - Ospedale Asilo Vittoria di Mortara - U.O. di Pneumotisiologia
city: Paderno Dugnano
country: Italy
facility: Clinica San Carlo - Casa di Cura Polispecialistica S.p.A. - Unità di Terapia del Dolore
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Pavia
country: Italy
facility: Azienda Servizi alla Persona, ASP, "II.AA.RR." - Istituto di Riabilitazione "Santa Margherita" - Struttura Complessa di Riabilitazione
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri - sede di Via Boezio - UO Cure Palliative e Terapia del Dolore
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico "Humanitas" - Anestesia, Day Hospital chirurgico - Chronic Pain Service
city: Torino
country: Italy
facility: Dipartimento Integrato di Lungassistenza Anziani - ASL TO1
city: Varese
country: Italy
facility: Ospedale di circolo Fondazione Macchi - SSD Anestesia Day Surgery
city: Vigevano
country: Italy
facility: Azienda Ospedaliera della Provincia di Pavia - Ospedale Civile di Vigevano - Servizio di Anestesia e Rianimazione
city: Voghera
country: Italy
facility: Azienda Ospedaliera della Provincia di Pavia - Ospedale Civile di Voghera- U.O. di Medicina Interna - U.O. di Riabilitazione specialistica
Study officials:
affiliation: IRCCS Fondazione San Matteo Pavia
name: Massimo Allegri, MD
role: PRINCIPAL_INVESTIGATOR
References: