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Long-term Opioid Therapy, Misuse and Mortality in Patients With Chronic Non-cancer Pain in Germany

NCT03778450 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3232

Last updated 2019-09-04

No results posted yet for this study

Summary

Among patients receiving opioids for noncancer pain, recent research in North America showed a strong association between doses and opioid-related mortality, especially at dosages exceeding thresholds recommended in recent guidelines. However, the focus on over-dosage may underestimate overall opioid-related mortality and data on death associated with opioid use in a population-based cohort of chronic noncancer pain patients in Europe is scarce. Especially comparative studies studying the safety of long-term opioid therapy in a real-world setting relative to non-opioid medication for chronic noncancer pain are needed in a European context.

Conditions

Interventions

DRUG

Analgesics, Opioid

Patients are included in the long-term opioid group if they started an opioid-therapy between 2013 and 2017 and received consecutive prescriptions for opioid medications over a minimum of 3 quarters, over a 60-month period between January 1, 2013, and December 31, 2017. The treatment will be assessed using the ATC codes of opioid treatment N02AA01, N02AA05, N02AB03, N02AE01, N02AX02, N02AX01, N02AX06) reported in reimbursed medicines to patients.

DRUG

Non-Opioid Analgesic

Patients with non-opioid pain medication are included, if they received a medication therapy with anticonvulsants (gabapentin, pregabalin, carbamazepine), antidepressants or non-opioid analgesics (NSAIDs, Metamizole) over a minimum of 3 quarters, over a 60-month period between January 1, 2013, and December 31, 2017. The non-opioid treatment will be assessed using the ATC codes (N03AX12, N03AX16, N03AF01) of treatment reported in reimbursed medicines to patients.

Sponsors & Collaborators

  • Grünenthal GmbH

    collaborator INDUSTRY

  • Klinikum Saarbrücken

    collaborator UNKNOWN

  • Ruhr University of Bochum

    collaborator OTHER

  • Technical University of Munich

    collaborator OTHER

  • LinkCare GmbH

    lead INDUSTRY

Principal Investigators

  • Tino Schubert · LinkCare GmbH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-05
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03778450 on ClinicalTrials.gov