Evaluation of the Efficacy and Tolerability of Etoricoxib Monotherapy Versus Combination Oxycodone-etoricoxib in Moderate to Severe Pain From Chronic Low Back Pain

NCT01344720 | Unknown Phase 4

• 1 other identifier: ASL 4 Teramo
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Low Back Pain

Keywords

Low Back Pain; Etoricoxib; Oxycodone

Outcome Measures

Primary Outcomes (1)

• 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).

  from baseline (avg of daily diary scores between visit 1 and 2) to the end of treatment week 5

Secondary Outcomes (1)

• Proportion of patients achieving a > 50% reduction in avg daily pain intensity at treatment week 5 (visit 4).

  from baseline (avg of 3 qualifying days from diary scores between visit 1 and 2) to the end of treatment week 5

Study Arms (2)

etoricoxib

ACTIVE COMPARATOR

etoricoxib up to 60mg/day as monotherapy

Drug: etoricoxib

etoricoxib plus controlled-release oxycodone

ACTIVE COMPARATOR

combination treatment of etoricoxib (30 mg/day) plus controlled-release oxycodone (10 mg/day)

Drug: oxycodone

Interventions

etoricoxib DRUG

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.

etoricoxib

oxycodone DRUG

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).

etoricoxib plus controlled-release oxycodone

Eligibility Criteria

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

You may qualify if:

• Male or female outpatients (at least 18 years of age).
• Patient with a confirmed diagnosis of moderate-to-severe CLBP present for more than 15 days per month and several hours per day for at least 6 months prior to screening.
• Achieve at least 3 consecutive days with an average daily pain score \> 4 during baseline week (between visit 1 and visit 2) via patient diary recordings.
• Patient is currently not receiving treatment for CLBP or was receiving treatment for CLBP, with a drug other than etoricoxib or oxycodone, and completed the required washout prior to Visit 2.
• Patient has never received treatment with etoricoxib or oxycodone and other strong opioids.
• No assumption of adjuvant drugs (antiepileptics, steroids, tricyclic antidepressants, SNRIs, muscle relaxants) in the last month (or two week).
• Patient has a level of understanding sufficient to provide written informed consent and to communicate with the investigator and site personnel.
• Patient is judged to be reliable, agrees to keep all appointments for clinic visits, and agrees to participate in recording responses to questionnaires and other instruments used in this study, as well as all other protocol procedures.
• All females of child-bearing potential must test negative for pregnancy at Visit 1, based on a serum pregnancy test. Females of child-bearing potential (not surgically sterilised and between menarche and 1 year post-menopause) must agree to use a medically acceptable and reliable means of birth control (as determined by the investigator) during the study and for 1 month following the last dose of study drug. Examples of reliable methods include use of oral contraceptives or Depo Provera Contraceptive Injection, abstinence, partner with vasectomy, diaphragm with contraceptive jelly, condom with contraceptive foam, and intrauterine devices.

You may not qualify if:

• Have a known hypersensitivity to NSAIDs or strong opioids or any of the inactive ingredients or have any contraindication for the use of etoricoxib or oxycodone:
• Patient with hypersensitivity to opioid analgesics;
• acute asthma or other obstructive airway disease and acute respiratory depression with hypoxia;
• elevated carbon dioxide levels in the blood; cor pulmonale; acute alcoholism; delirium tremens;severe CNS depression; convulsive disorders; increased cerebrospinal or intracranial pressure;
• head injury; suspected surgical abdomen (paralytic ileus); concomitant MAO inhibitors (or within 14 days of such therapy).
• Hypersensitivity to the active substance or to any of the excipients of etoricoxib formulation.
• Active peptic ulceration or active gastro-intestinal (GI) bleeding.
• Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
• Pregnancy and lactation
• Severe hepatic dysfunction (serum albumin \<25 g/l or Child-Pugh score ≥10).
• Estimated renal creatinine clearance \<30 ml/min.
• Inflammatory bowel disease.
• Congestive heart failure (NYHA II-IV).
• Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled.
• Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.

Sponsors & Collaborators

• Azienda Sanitaria Locale 4, Teramo: lead

Study Sites (5)

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, 67100, Italy

Location

Unità di riabilitazione neurofisiologica Istituto Scientifico di Riabilitazione di Montescano

Montescano (PV), Pavia, 27040, Italy

Location

Clinica Anestesia e Rianimazione Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Roma, Roma, 00133, Italy

Location

Dipartimento Emergenza ed Accettazione Ospedale Civile G. Mazzini Teramo

Teramo, Teramo, 64100, Italy

Location

Dipartimento di Medicina Interna- Università degli Studi di Perugia Azienda Ospedaliera S.Maria - Clinica Medica

Terni, Terni, 05100, Italy

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Etoricoxib; Oxycodone

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Pier Luigi Orsini, Dottore

  Dipartimento Emergenza ed Accettazione Ospedale Civile G. Mazzini Teramo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pier Luigi Orsini, Dottore

CONTACT

3289759877; orsinipl@libero.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 29, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 29, 2011

Record last verified: 2011-03

Locations

IT (5)