Non interventional study “Oxycodon-HCl beta, 1 x täglich Retardtabletten”

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00005374

Enrollment

10000

Registered

2013-10-18

Start date

2013-10-10

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe pain that can only be adequately treated with Opioid analgesics. R52.9

Interventions

Group 1: After the patient has given his consent to the disclosure of his pseudomised data, the following data will be documented by the attending physician: - demographics - type of pain and pain sym

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients may be included in the non-interventional study if the following criteria are met: - Treatment with “Oxycodon-HCl beta, 1 x täglich Retardtabletten” - The patient is an adult - The patient has been informed in detail about the study by the attending physician. A written informed consent for participation in the study has been provided by the patient or his legal representative.

Exclusion criteria

Exclusion criteria: no exclusion criteria

Design outcomes

Primary

Measure	Time frame
It is the objective of this non interventional study to obtain further knowledge about efficacy and tolerability of “Oxycodon-HCl beta, 1 x täglich Retardtabletten” application in a large population of adult patients who are treated for severe pain in the context of standard medical care. This observational study will be conducted under everyday conditions in medical practices and is meant to gather more detailed information about the use of “Oxycodon-HCl beta, 1 x täglich Retardtabletten” and pain-related concomitant medication. In the course of the therapy, the patient documents the analgesic efficacy of “Oxycodon-HCl beta, 1 x täglich Retardtabletten” on a scale of 0 to 10 and evaluates the impairment of his/her quality of life in various aspects of everyday life (general activity, sleep, ability to walk, mood, vitality, social contacts, resilience, work. Assessment by means of scales from 0 to 10.) The Patient completes the questionnaire at each visit and rates the last three days. In order to document drug tolerability, all adverse events and special situations (lack of therapeutic efficacy (despite sufficient dosage), overdose, abuse, misuse, medication error, occupational exposure, use during pregnancy or breastfeeding, offlabel use) which occur during the non-interventional study will be documented.	—

Measure

Time frame

It is the objective of this non interventional study to obtain further knowledge about efficacy and tolerability of “Oxycodon-HCl beta, 1 x täglich Retardtabletten” application in a large population of adult patients who are treated for severe pain in the context of standard medical care. This observational study will be conducted under everyday conditions in medical practices and is meant to gather more detailed information about the use of “Oxycodon-HCl beta, 1 x täglich Retardtabletten” and pain-related concomitant medication. In the course of the therapy, the patient documents the analgesic efficacy of “Oxycodon-HCl beta, 1 x täglich Retardtabletten” on a scale of 0 to 10 and evaluates the impairment of his/her quality of life in various aspects of everyday life (general activity, sleep, ability to walk, mood, vitality, social contacts, resilience, work. Assessment by means of scales from 0 to 10.) The Patient completes the questionnaire at each visit and rates the last three days. In order to document drug tolerability, all adverse events and special situations (lack of therapeutic efficacy (despite sufficient dosage), overdose, abuse, misuse, medication error, occupational exposure, use during pregnancy or breastfeeding, offlabel use) which occur during the non-interventional study will be documented.

—

Countries

Germany

Contacts

Public ContactUlrike Paulus

betapharm Arzneimittel GmbH

upaulus at betapharm.de0821-74 881-587

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026