DIFFERENTIAL GASTROINTESTINAL EFFECTS OF WHO-STEP III OPIOIDS IN LOW BACK PAIN PATIENTS WITH VS. WITHOUT CONSTIPATION: POST-HOC ANALYSIS OF DATA FROM A 12-WEEK PROSPECTIVE, OPEN-LABEL BLINDED ENDPOINT STREAMLINED STUDY (PROBE-PHA2)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/11049
• EU PAS number:
  EUPAS11048
• Study ID:
  11049
• Official title and acronym:
  DIFFERENTIAL GASTROINTESTINAL EFFECTS OF WHO-STEP III OPIOIDS IN LOW BACK PAIN PATIENTS WITH VS. WITHOUT CONSTIPATION: POST-HOC ANALYSIS OF DATA FROM A 12-WEEK PROSPECTIVE, OPEN-LABEL BLINDED ENDPOINT STREAMLINED STUDY (PROBE-PHA2)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Post-hoc analysis of data from a prospective, randomized, open-label, blinded endpoint (PROBE) streamlined study, 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. In this post-hoc analysis, patients will be grouped with respect to their bowel function index and characterized as normal (NCP, BFI ≤28.8mm VAS, n=643) or constipated (COP, >28.8mm VAS, n=258). 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: 08/06/2015

Actual: 08/06/2015

Study start date

Planned: 04/03/2013

Actual: 01/04/2013

Data analysis start date

Planned: 15/06/2015

Actual: 15/06/2015

Date of final study report

Planned: 31/07/2015

Actual: 31/07/2015

Sources of funding

Other

More details on funding

Institute for Neurological Sciences

Regulatory

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