Treatment of Chronic Pain From Osteoarthritis

NCT02032927 | Withdrawn Phase 4

• 1 other identifier: PT-SM-14-OA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 14

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.

Conditions

Chronic Pain

Keywords

osteoarthritis; pain; opioids

Outcome Measures

Primary Outcomes (1)

• Evaluate differences in terms of efficacy and tolerability between two pharmaceutical protocols in patients with chronic pain due to osteoarthritis.

  The number of patients has been estimated considering that, at 15 days of enrollment, a reduction of 30% of the WOMAC pain subscale, with a score at BFI \<50, the use of not more than one laxative drug or the absence of side effects such as to consider the need to discontinue therapy occurs in 80% of patients in Protocol B versus 50% of patients in Protocol A, with 73 patients per group will be able to highlight an odds ratio (OR) 2.65 with a power of 80% and an alpha error of 5% (2-tailed). The calculation was performed with nQuery 4 (Statistical Solutions, Cork, IRL). Considering a drop out rate of about 24% is numerosity you plan to enroll a total of 182 patients in order to obtain 146 patients valid.

  15 days from the enrolment

Secondary Outcomes (3)

• Evaluate the differences between the two drug protocols, in terms of quality of life, by using of the SF-12 questionnaire.

  3 months from the enrollment

• Evaluation of the differences between the two drug protocols, in the scores obtained in the two sections, functionality and rigidity of the WOMAC questionnaire.

  3 months from the enrollment

• 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.

  3 months from the enrollment

Study Arms (2)

Codeine/paracetamol

ACTIVE COMPARATOR

The combination codeine/paracetamol,30 mg/500 mg,1 tablet every 8 hours, paracetamol 500 mg if NRS\> 4, repeatable up to 3 times per day. At any stage of the study, patients treated with combination codeine/paracetamol in case of ineffectiveness (NRS\> 4) despite maximal dosage (2 tablets every 8 hours) and/or side effect, will be subject to the opioid switch and will start equianalgesic therapy with oxycodone/naloxone combination.

Drug: Codeine/paracetamol

Oxycodone/Naloxone

ACTIVE COMPARATOR

Combination oxycodone /naloxone, 5 mg/2.5 mg, 1 tablet/day, paracetamol 500 mg if NRS\> 4, repeatable up to 3 times per day.

Drug: Oxycodone/naloxone

Interventions

Codeine/paracetamol DRUG

Randomization to one of the two treatments will be done through appropriate randomization list. During the first 15 days of treatment in the event of failure of efficacy, understood as the average pain intensity higher than 4 (monitored with NRS) with the need to take more than two rescue doses of paracetamol per day, and in the absence of side effects, the patients will be instructed on how to proceed with dosage adjustments according to specific guidelines. The patient will be evaluated at 15 days, 1 month, 2 months and three months. Your health care professional who administer the assessment scales (WOMAC, SF-12, BFI, TMT) will not know in any way which treatment the patient is taking.

Codeine/paracetamol

Oxycodone/naloxone DRUG

Randomization to one of the two treatments will be done through appropriate randomization list. During the first 15 days of treatment in the event of failure of efficacy, understood as the average pain intensity higher than 4 (monitored with NRS) with the need to take more than two rescue doses of paracetamol per day, and in the absence of side effects, the patients will be instructed on how to proceed with dosage adjustments according to specific guidelines. The patient will be evaluated at 15 days, 1 month, 2 months and three months. Your health care professional who administer the assessment scales (WOMAC, SF-12, BFI, TMT) will not know in any way which treatment the patient is taking.

Oxycodone/Naloxone

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (14)

Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, 27100, Italy

Location

Azienda Ospedaliera della Provincia di Pavia - Ospedale "Carlo Mira" - U.O. Medicina Interna - Servizio di Anestesia e Rianimazione - Ambulatorio di Terapia del dolore

Casorate Primo, Italy

Location

Azienda Istituti Ospitalieri di Cremona, Presidio Ospedaliero di Cremona - U.O. di Anestesia, Analgesia e Medicina Perioperatoria

Cremona, Italy

Location

Azienda Ospedaliera della provincia di Lodi Dipartimento emergenza urgenza

Lodi, Italy

Location

Azienda Ospedaliera Istituto Ortopedico Gaetano Pini - U.O.C. Anestesia e Rianimazione

Milan, Italy

Location

Azienda Ospedaliera della Provincia di Pavia - Ospedale Asilo Vittoria di Mortara - U.O. di Pneumotisiologia

Mortara, Italy

Location

Clinica San Carlo - Casa di Cura Polispecialistica S.p.A. - Unità di Terapia del Dolore

Paderno Dugnano, Italy

Location

Azienda Servizi alla Persona, ASP, "II.AA.RR." - Istituto di Riabilitazione "Santa Margherita" - Struttura Complessa di Riabilitazione

Pavia, Italy

Location

Fondazione Salvatore Maugeri - sede di Via Boezio - UO Cure Palliative e Terapia del Dolore

Pavia, Italy

Location

IRCCS Istituto Clinico "Humanitas" - Anestesia, Day Hospital chirurgico - Chronic Pain Service

Rozzano, Italy

Location

Dipartimento Integrato di Lungassistenza Anziani - ASL TO1

Torino, Italy

Location

Ospedale di circolo Fondazione Macchi - SSD Anestesia Day Surgery

Varese, Italy

Location

Azienda Ospedaliera della Provincia di Pavia - Ospedale Civile di Vigevano - Servizio di Anestesia e Rianimazione

Vigevano, Italy

Location

Azienda Ospedaliera della Provincia di Pavia - Ospedale Civile di Voghera- U.O. di Medicina Interna - U.O. di Riabilitazione specialistica

Voghera, Italy

Location

MeSH Terms

Conditions

Chronic Pain; Osteoarthritis; Pain

Interventions

acetaminophen, codeine drug combination; Oxycodone; Naloxone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Massimo Allegri, MD

  IRCCS Fondazione San Matteo Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 10, 2014
• Study Start: June 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

IT (14)