Prevalence of drug-induced constipation and severity of associated biopsychosocial effects in patients with nonmalignant pain. A cross-sectional review of depersonalized data from the German Pain e-Registry (DRIP)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42287
• EU PAS number:
  EUPAS42286
• Study ID:
  42287
• Official title and acronym:
  Prevalence of drug-induced constipation and severity of associated biopsychosocial effects in patients with nonmalignant pain. A cross-sectional review of depersonalized data from the German Pain e-Registry (DRIP)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Constipation is a frequent medical problem and affects, depending on methodological and geographic differences, up to 28% of the general population. Epidemiological studies showed that the prevalence of constipation increases with age, is higher in women compared to men and severity as well as time course are very variable. Likewise are the correlating effects on quality of life and well-being variable. Drug induced constipation (DIC) is one of the most frequent adverse reactions and a frequent reason for (co-)morbidity in otherwise healthy persons as well as in pain patients in all parts of the world. Reports on DIC in pain patients largely address opioid-induced constipation (OIC) as one aspect of opioid-induced bowel dysfunction. However, DIC also occurs in response to non-opioid analgesics and pain related co-medication such as non-steroidal anti-inflammatory drugs (NSAIDs), antidepressants (ADDs), anticonvulsants (AEDs)and others. Furthermore, recent studies in elderly non-pain patients reported a correlation between occurrence and severity of constipation and the overall number of drugs used. This raises questions on a potential impact of analgesic polypharmacy on the prevalence and the biopsychosocial consequences of constipation in patients with chronic nonmalignant pain (NMP), who frequently receive a polymedication with or without opioid analgesics. To gain further insight into the prevalence and biopsychosocial consequences of DIC in patients with NMP we evaluated anonymized real-world data derived from routine medical care in pain centers within the German Pain e-Registry (GPeR), a national web-based registry developed in cooperation with the German Pain Association (Deutsche Gesellschaft für Schmerzmedizin) and the German Pain League (Deutsche Schmerzliga).
• Study status:
  Finalised

Research institutions and networks

Institutions

Institute for Neurological Sciences (IFNAP)

Study timelines

Date when funding contract was signed

Planned: 02/03/2021

Actual: 02/03/2021

Study start date

Planned: 02/03/2021

Actual: 02/03/2021

Data analysis start date

Planned: 03/05/2021

Actual: 03/05/2021

Date of final study report

Planned: 23/07/2021

Actual: 23/07/2021

Sources of funding

Other

More details on funding

IFNAP - private Institute of Neurological Sciences

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable