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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Azienda Sanitaria Locale 4, Teramo.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Azienda Sanitaria Locale 4, Teramo
ClinicalTrials.gov Identifier:
NCT01344720
First received: April 13, 2011
Last updated: April 28, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Drug: etoricoxib
Drug: oxycodone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Tolerability of Etoricoxib Monotherapy Versus Combination Oxycodone-etoricoxib in Moderate to Severe Pain From Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Azienda Sanitaria Locale 4, Teramo:

Primary Outcome Measures:
  • Proportion of patients achieving a > 30% reduction in avg daily pain intensity at treatment week 4 (Visit 4). [ Time Frame: from baseline (avg of daily diary scores between visit 1 and 2) to the end of treatment week 5 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Proportion of patients achieving a > 50% reduction in avg daily pain intensity at treatment week 5 (visit 4). [ Time Frame: from baseline (avg of 3 qualifying days from diary scores between visit 1 and 2) to the end of treatment week 5 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 250
Study Start Date: May 2011
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: etoricoxib
etoricoxib up to 60mg/day as monotherapy
Drug: etoricoxib

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.

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

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).


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Have previously completed or withdrawn from this study or any other study investigating etoricoxib or oxycodone or have previously been treated with etoricoxib or oxycodone.
  • Have a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
  • Have a positive urine drug screen for substances of abuse. Women who are breast-feeding.
  • Have a historical exposure to drugs known to cause neuropathy (for example, vincristine), or a history of a medical condition, including pernicious anaemia and hypothyroidism, that could have been responsible for neuropathy.
  • Have pain that cannot be clearly differentiated from or conditions that interfere with the assessment of the CLBP. Examples of painful conditions that could be confused like peripheral vascular disease (ischemic pain); neurological disorders (for example, phantom limb pain from amputation); skin condition in the area of the neuropathy that could alter sensation (for example, plantar ulcer); other painful conditions (for example, arthritis, neoplasm, fibromyalgia, CRPS).
  • Have a history of neurosurgical procedures for pain control, nerve/plexus blocs or ablation within 6 months prior to screening.
  • Psychological conditions that, in the opinion of the investigator, would compromise participation or be likely to require hospitalization during the course of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344720

Contacts
Contact: Pier Luigi Orsini, Dottore 3289759877 orsinipl@libero.it

Locations
Italy
Unità di riabilitazione neurofisiologica Istituto Scientifico di Riabilitazione di Montescano Not yet recruiting
Montescano (PV), Pavia, Italy, 27040
Principal Investigator: Roberto Casale, Professore         
Dipartimento di Scienze della Salute Anestesia, Rianimazione e Terapia del dolore - Università degli Studi di L'Aquila Ospedale San Salvatore L'Aquila Not yet recruiting
L'Aquila, Italy, 67100
Principal Investigator: Franco Marinangeli, Dottore         
Clinica Anestesia e Rianimazione Azienda Ospedaliera Universitaria Policlinico Tor Vergata Not yet recruiting
Roma, Italy, 00133
Principal Investigator: Antonio Gatti, Dottore         
Dipartimento Emergenza ed Accettazione Ospedale Civile G. Mazzini Teramo Not yet recruiting
Teramo, Italy, 64100
Principal Investigator: Pier Luigi Orsini, Dottore         
Dipartimento di Medicina Interna- Università degli Studi di Perugia Azienda Ospedaliera S.Maria - Clinica Medica Not yet recruiting
Terni, Italy, 05100
Principal Investigator: Stefano Coaccioli, Professore         
Sponsors and Collaborators
Azienda Sanitaria Locale 4, Teramo
Investigators
Principal Investigator: Pier Luigi Orsini, Dottore Dipartimento Emergenza ed Accettazione Ospedale Civile G. Mazzini Teramo
  More Information

No publications provided

Responsible Party: Dott. Pier Luigi Orsini, Dipartimento Emergenza ed Accettazione Ospedale Civile G. Mazzini Teramo
ClinicalTrials.gov Identifier: NCT01344720     History of Changes
Other Study ID Numbers: ASL 4 Teramo
Study First Received: April 13, 2011
Last Updated: April 28, 2011
Health Authority: Italia: Comitato Etico

Keywords provided by Azienda Sanitaria Locale 4, Teramo:
Low Back Pain
Etoricoxib
Oxycodone

Additional relevant MeSH terms:
Low Back Pain
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Oxycodone
Etoricoxib
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 26, 2014