NCT02032927

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

Withdrawn Phase 4 Last updated 18 April 2017

What this trial tests

Phase 4 trial testing Codeine/paracetamol in Chronic Pain. Withdrawn.

Timeline

1 June 2013

Primary endpoint
1 June 2015

1 June 2015

Quick facts

Lead sponsor	Fondazione IRCCS Policlinico San Matteo di Pavia
Phase	Phase 4
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Start date	1 June 2013
Primary completion	1 June 2015
Estimated completion	1 June 2015
Sites	14 locations across Italy

Drugs / interventions tested

• Codeine/paracetamol
• Oxycodone/naloxone

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Who can join

Adults 60 to 100, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Evaluate differences in terms of efficacy and tolerability between two pharmaceutical protocols in patients with chronic pain due to osteoarthritis.
  Time frame: 15 days from the enrolment
  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 ab

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.