Clinical trial · Observational
Long-term Opioid Therapy, Misuse and Mortality in Patients With Chronic Non-cancer Pain in Germany
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Analgesics, Opioid | Drug | — | UNRESOLVED |
| Non-Opioid Analgesic | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Analgesics, Opioid
- description
- 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.
- interventionNames
- Drug: Analgesics, Opioid
- label
- Non-Opioid Analgesic
- description
- Patients are only included if they have been diagnosed in at least three quarters in 2012 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.
- interventionNames
- Drug: Non-Opioid Analgesic
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- 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 Criteria: * 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.
References
Publications (1)
- DERIVEDHauser W, Schubert T, Vogelmann T, Maier C, Fitzcharles MA, Tolle T. All-cause mortality in patients with long-term opioid therapy compared with non-opioid analgesics for chronic non-cancer pain: a database study. BMC Med. 2020 Jul 15;18(1):162. doi: 10.1186/s12916-020-01644-4. PMID 32664901