Safety and efficacy of oxycodone/naloxone vs. oxycodone vs. morphine in the treatment of chronic low back pain - a 12-week prospective (optionally randomized) open-label blinded endpoint streamlinded study with prolonged-release preparations (PROBE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/11053
• EU PAS number:
  EUPAS11035
• Study ID:
  11053
• Official title and acronym:
  Safety and efficacy of oxycodone/naloxone vs. oxycodone vs. morphine in the treatment of chronic low back pain - a 12-week prospective (optionally randomized) open-label blinded endpoint streamlinded study with prolonged-release preparations (PROBE)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  12-week observational parallel group study in patients with chronic low back pain qualifying for a treatment with WHO-Step III opioids. The study will be performed by using electronic case report forms for all data obtained by the participating physicians as well as conventional paper-pencil pain questionnaires/diaries to obtain patient-reported data throughout the whole 12-week observation period. Patient questionnaires/diaries used were those recommended by the German Pain Association and the German Pain League.Patients eligible for this study are males and non-pregnant, non-lactating females who are at least 18 years with a documented history of moderate to severe non-malignant chronic low back pain, previously treated with WHO-step I or II analgesics with or without adjuvant treatments who experienced either insufficient pain relief and/or unacceptable side effects and who require an around-the clock therapy with any of the three mentioned WHO-step III opioids. Exclusion criteria for this study are those contraindications listed in the German prescribing information of the three opioid analgesics that address situations that would place the patient at risk upon exposure to the medication as well as conditions that would confound the analysis and/or interpretation of the study results.Efficacy assessments wil be performed on the basis of patient-reported information documented in the German Pain Questionnaire (at baseline) and the German Pain Diary (throughout the whole observation period) for pain intensity, pain-related disabilities in daily life activities/functionality and quality-of-life. Safety assessments will consist of monitoring all treatment-emergent adverse events (TEAEs). In addition, OIC will be assessed using the validated bowel function index (BFI).Aim of this study is to demonstrate (a) the superiority of OXN vs. OXY vs. MOR with respect to OIC, and (b) the non-inferiority of OXN vs. OXY vs MOR with respect to pain relief.
• Study status:
  Finalised

Research institutions and networks

Institutions

Institute for Neurological Sciences (IFNAP)

Multiple centres: 88 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 03/12/2012

Actual: 03/12/2012

Study start date

Planned: 04/03/2013

Actual: 01/04/2013

Data analysis start date

Planned: 02/12/2013

Actual: 03/03/2014

Date of final study report

Planned: 01/04/2014

Actual: 01/09/2014

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Mundipharma Germany, Institute for Neurological Sciences

Regulatory

• Was the study required by a regulatory body?:
  No