Low Back PainPhase 4NCT01344720
Evaluation of the Efficacy and Tolerability of Etoricoxib Monotherapy Versus Combination Oxycodone-etoricoxib in Moderate to Severe Pain From Chronic Low Back Pain
A Phase 4 study testing etoricoxib and oxycodone in people with Low Back Pain, run by Azienda Sanitaria Locale 4, Teramo at 5 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- etoricoxib and oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 5 sitesItaly
- Study dates
- May 2011to Jun 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
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
Franco Marinangeli, Dottore
Unità di riabilitazione neurofisiologica Istituto Scientifico di Riabilitazione di Montescano
Montescano (PV), Pavia, 27040
Roberto Casale, Professore
Clinica Anestesia e Rianimazione Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, Roma, 00133
Antonio Gatti, Dottore
Dipartimento Emergenza ed Accettazione Ospedale Civile G. Mazzini Teramo
Teramo, Teramo, 64100
Pier Luigi Orsini, Dottore
Dipartimento di Medicina Interna- Università degli Studi di Perugia Azienda Ospedaliera S.Maria - Clinica Medica
Terni, Terni, 05100
Stefano Coaccioli, Professore
About this study
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
- Being tested
- etoricoxib, oxycodone
- Keywords
- Low Back Pain, Etoricoxib, Oxycodone
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etoricoxibDrug
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.
oxycodoneDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| etoricoxib | Active comparator | etoricoxib up to 60mg/day as monotherapy Receives: Drug: etoricoxib |
| etoricoxib plus controlled-release oxycodone | Active comparator | combination treatment of etoricoxib (30 mg/day) plus controlled-release oxycodone (10 mg/day) Receives: Drug: oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
- Proportion of patients achieving a > 50% reduction in avg daily pain intensity at treatment week 5.
- Proportion of patients achieving a > 30% reduction in avg daily pain intensity at treatment week 3 (visit 3).
- Average daily change in pain intensity from baseline to treatment week 5
- Average daily change in pain intensity from baseline to treatment week 3
- Mean change in CLBP Disability from baseline to end of treatment week 5
Measured: from baseline (avg of 3 qualifying days from diary scores between visit 1 and 2) to the end of treatment week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale 4, Teramo
- Sponsor type
- University, hospital or other
- Investigators
- Pier Luigi Orsini, Dottore, Principal investigator, Dipartimento Emergenza ed Accettazione Ospedale Civile G. Mazzini Teramo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344720
- Sponsor's protocol ID
- ASL 4 Teramo
- Status last verified
- Mar 2011
- First submitted
- 13 Apr 2011
- Last updated
- 29 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01344720
- Acronym / sponsor ID
- ASL 4 Teramo
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Etoricoxib, Oxycodone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale 4, TeramoUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 29 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| etoricoxib | Active comparator | Drug: etoricoxibetoricoxib up to 60mg/day as monotherapy |
| etoricoxib plus controlled-release oxycodone | Active comparator | Drug: oxycodonecombination treatment of etoricoxib (30 mg/day) plus controlled-release oxycodone (10 mg/day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etoricoxibAt 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. | Drug | etoricoxib |
| oxycodoneAt 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). | Drug | etoricoxib plus controlled-release oxycodone |
Primary outcome
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
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).
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pier Luigi Orsini, Dottore principal investigator
Dipartimento Emergenza ed Accettazione Ospedale Civile G. Mazzini Teramo
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing etoricoxib and oxycodone in people with Low Back Pain, run by Azienda Sanitaria Locale 4, Teramo at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pier Luigi Orsini, Dottore (3289759877, orsinipl@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2011.