NON-INTERVENTIONAL OBSERVATIONAL STUDY FOR THE EVALUATION OF TOLERABILITY AND EFFICACY OF THE WHO-STEP III OPIOIDS OXYCODONE/NALOXONE PR AND TAPENTADOL PR UNDER DAILY LIFE CONDITIONS IN PATIENTS SUFFERING FROM NEUROPATHIC (LOW) BACK PAIN. (OXYNTA)

Study identification

• EU PAS number:
  EUPAS11234
• Study ID:
  11235
• Official title and acronym:
  NON-INTERVENTIONAL OBSERVATIONAL STUDY FOR THE EVALUATION OF TOLERABILITY AND EFFICACY OF THE WHO-STEP III OPIOIDS OXYCODONE/NALOXONE PR AND TAPENTADOL PR UNDER DAILY LIFE CONDITIONS IN PATIENTS SUFFERING FROM NEUROPATHIC (LOW) BACK PAIN. (OXYNTA)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Prospective, open-label, blinded endpoint (PROBE) streamlined multicentre 12-week observational study, carried out in Germany focusing on the safety, tolerability and efficacy of prolonged release (PR) preparations of oxycodone/naloxone and tapentadol in patients suffering from neuropathic (low) back pain, requiring WHO-step III opioids. Due to the open-label non-interventional study design, physicians are allowed to choose the most appropriate agent for the individual patient situation, to adjust/titrate opioid dosages as per the German prescribing information and to address all side-effects and tolerability issues as usual to achieve the best tolerability and efficacy in each individual patient.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Institute for Neurological Sciences (IFNAP)

Study timelines

Date when funding contract was signed

Planned: 02/01/2015

Actual: 02/01/2015

Study start date

Planned: 01/04/2015

Actual: 01/04/2015

Data analysis start date

Planned: 02/11/2015

Date of final study report

Planned: 01/04/2016

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Mundipharma, IFNAP

Regulatory

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