Status:
COMPLETED
Long-term Opioid Therapy, Misuse and Mortality in Patients With Chronic Non-cancer Pain in Germany
Lead Sponsor:
LinkCare GmbH
Collaborating Sponsors:
Grünenthal GmbH
Klinikum Saarbrücken
Conditions:
Pain
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
This is a cross-sectional observational cohort study between 2012 and 2017 of patients with chronic noncancer pain. The primary objective is to investigate the association between mortality among pati...
Eligibility Criteria
Inclusion
- \- Patients are only included if they have been diagnosed in at least three quarters in the study period with one of the following diagnoses: R51, R52\*, M00\*-M99\*, G43\*-G44\*, G50.0 or G50.1, F45.4\*, G62\*, or E10.4\*-E14.4 plus G63.3. At least one diagnoses must be between 1 January 2012 and index treatment and main and secondary hospital diagnoses (i.e. Haupt- und Nebendiagnosen) will be used to include the patients.
Exclusion
- Patients with present opioid and non-opioid pain medication prescriptions in 2012 are excluded from analysis (therapy-naïve patients only).
- Cancer patients will be excluded if the cancer diagnosis is accompanied by at least one of the following treatments in the same quarter: radiation therapy or chemotherapy all defined by the OPS codes in. Diagnoses will be assessed via ICD-10 diagnoses during the inclusion period from 1 January 2012 until index treatment and main and secondary hospital diagnoses (i.e. Haupt- und Nebendiagnosen) will be taken into account.
- Palliative care, coded by ICD-10 code Z51.5 or OPS code 8-982\*, 8-98e\*, 8-98h\* before index date is excluded
- Opioid substitution treatment with ICD-10 code Z51.83 in the study period is excluded.
Key Trial Info
Start Date :
December 5 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
3232 Patients enrolled
Trial Details
Trial ID
NCT03778450
Start Date
December 5 2018
End Date
August 31 2019
Last Update
September 4 2019
Active Locations (1)
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1
LinkCare GmbH
Stuttgart, Germany, 70469