DEVELOPMENT OF OPIOID-INDUCED CONSTIPATION: POST-HOC ANALYSIS OF DATA FROM A 12-WEEK PROSPECTIVE, OPEN-LABEL BLINDED ENDPOINT STREAMLINED STUDY IN LOW-BACK PAIN PATIENTS, TREATED WITH PROLONGED-RELEASE WHO-STEP III OPIOIDS (PROBE-PHA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/11040
• EU PAS number:
  EUPAS11039
• Study ID:
  11040
• Official title and acronym:
  DEVELOPMENT OF OPIOID-INDUCED CONSTIPATION: POST-HOC ANALYSIS OF DATA FROM A 12-WEEK PROSPECTIVE, OPEN-LABEL BLINDED ENDPOINT STREAMLINED STUDY IN LOW-BACK PAIN PATIENTS, TREATED WITH PROLONGED-RELEASE WHO-STEP III OPIOIDS (PROBE-PHA)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Opioid-induced constipation (OIC) is the most prevalent patient complaint associated with longer-term opioid use and interferes with analgesic efficacy, functionality, quality-of-life, and patient compliance.Objectives of this study are to compare effects of prolonged release (PR) oxycodone and PR naloxone (OXN), vs. PR oxycodone (OXY) vs. PR morphine (MOR) on bowel function under real-life conditions in chronic low back pain (LBP) patients refractory to WHO-step I and/or II analgesics.Analyses will base on the complete data set of an already completed prospective (optionally randomized), 12-week open-label, blinded endpoint (PROBE) streamlined study (German pain study registry: 2012-0012-05, ENCEPP trial registry...), carried out in 88 centres in Germany, where a total of 901 patients, requiring WHO-step III opioids to treat low back pain, were enrolled, and prospectively observed for 3 months. Opioid allocation based on either optional randomization (453) or physician decision (448). In both groups, treatment doses could be adjusted as per the German prescribing information and physicians were free to address all side-effects and tolerability issues as usual.
• Study status:
  Finalised

Research institutions and networks

Institutions

Institute for Neurological Sciences (IFNAP)

Study timelines

Date when funding contract was signed

Planned: 09/03/2015

Actual: 09/03/2015

Study start date

Planned: 04/03/2013

Actual: 01/04/2013

Data analysis start date

Planned: 16/03/2015

Actual: 16/03/2015

Date of final study report

Planned: 04/05/2015

Actual: 04/05/2015

Sources of funding

Other

More details on funding

Institute for Neurological Sciences

Regulatory

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