This randomized, single-blind, parallel-group study will investigate the efficacy and the tolerability of a combination treatment of etoricoxib (30 mg/day) plus controlled-release oxycodone (10 mg/day) compared with a titrated dose of etoricoxib up to 60mg/day as monotherapy , in patients with Chronic Low Back Pain (CLBP) who have not responded to the starting dose of Etoricoxib 30mg/day. A common clinical question is that is it better to increase the dose of the current monotherapy or to combine both treatments early on, in patients who do not respond to standard start doses of NSAIDs like etoricoxib.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
250
At visit 2 eligible patients will then receive Etoricoxib 30mg for 2 weeks. Patients who achieve a clinically meaningful improvement in pain at the end of this period (defined as a ≥30% improvement in BPI avg daily pain intensity), will continue therapy up to week 5 (visit 4), if they become "non-responders" between week 4-5, they can be tapered off meds and then discontinued from the study. Patients who do not achieve a clinically meaningful improvement will be considered "non-responders" and will be randomized to receive either titration of their monotherapy or combination treatment. Group 1 "non-responders" will receive an increase in monotherapy from etoricoxib 30mg to eterocoxib 60mg/die.
At visit 2 eligible patients will then receive Etoricoxib 30mg for 2 weeks. Patients who achieve a clinically meaningful improvement in pain at the end of this period (defined as a ≥30% improvement in BPI avg daily pain intensity), will continue therapy up to week 5 (visit 4), if they become "non-responders" between week 4-5, they can be tapered off meds and then discontinued from the study. Patients who do not achieve a clinically meaningful improvement will be considered "non-responders" and will be randomized to receive either titration of their monotherapy or combination treatment. Group 2 "non-responders" will receive in addition to etoricoxib 30mg/day a dose of oxycodone CR 5mg q12hr (dose of 5mg tablet is available in Italy).
Dipartimento di Scienze della Salute Anestesia, Rianimazione e Terapia del dolore - Università degli Studi di L'Aquila Ospedale San Salvatore L'Aquila
L’Aquila, L'Aquila, Italy
Unità di riabilitazione neurofisiologica Istituto Scientifico di Riabilitazione di Montescano
Montescano (PV), Pavia, Italy
Clinica Anestesia e Rianimazione Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, Roma, Italy
Dipartimento Emergenza ed Accettazione Ospedale Civile G. Mazzini Teramo
Teramo, Teramo, Italy
Dipartimento di Medicina Interna- Università degli Studi di Perugia Azienda Ospedaliera S.Maria - Clinica Medica
Terni, Terni, Italy
Proportion of patients achieving a > 30% reduction in avg daily pain intensity at treatment week 4 (Visit 4).
Proportion of patients achieving a \> 30% reduction in avg daily pain intensity at treatment week 4 (Visit 4). Pain will be measured by the mean change of question #5 (avg daily pain intensity) of the Brief Pain Inventory (BPI) Modified Short Form from baseline (avg of daily diary scores between visit 1 and 2) to the end of treatment week 5 (Visit 4).
Time frame: from baseline (avg of daily diary scores between visit 1 and 2) to the end of treatment week 5
Proportion of patients achieving a > 50% reduction in avg daily pain intensity at treatment week 5 (visit 4).
1. Proportion of patients achieving a \> 50% reduction in avg daily pain intensity at treatment week 5. 2. Proportion of patients achieving a \> 30% reduction in avg daily pain intensity at treatment week 3 (visit 3). 3. Average daily change in pain intensity from baseline to treatment week 5 4. Average daily change in pain intensity from baseline to treatment week 3 5. Mean change in CLBP Disability from baseline to end of treatment week 5
Time frame: from baseline (avg of 3 qualifying days from diary scores between visit 1 and 2) to the end of treatment week 5
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