Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT03778450
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03778450
Study Brief:
Protocol Section:
NCT03778450