Trial document




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  DRKS00005374

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In Germany, "Oxycodon-HCl beta, 1 x täglich Retardtabletten" has been approved since June 2013 for treatment of adults and adolescents aged 12 years and older, whose severe pain can only be treated sufficiently with Opioid analgesics.
The 24 h lasting effect of a single dose applied once a day is due to the special pharmacokinetic characteristics of the study medication.
Compared to the bi-phasic release of active substance in the controlled release formula of the twice-a-day Oxycodon application, the prolonged release formula of the once-a-day Oxycodon application is characterized by an initial increase in study medication level over 4 hours followed by a plateau which lasts about 10 hours and then continuously decreases over 24 hours after application. This effect depends on a regular application of study medication.
It is reasonable to suggest that the once-a-day application may facilitate pain management and consequently means less impairment in everyday life for the patients.

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 observation conducted under everyday conditions in medical practices 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.
In order to document drug tolerability, all adverse events and special situations which occur during the non-interventional study will be recorded.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005374
  •   2013/10/18
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  •   no
  •   Approved
  •   FF 103/2013, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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Health Condition or Problem studied

  •   Severe pain that can only be adequately treated with Opioid analgesics.
  •   R52.9 -  Pain, unspecified
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Interventions/Observational Groups

  •   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 symptoms,
    - current analgesic medication and other concomitant pain medication at baseline
    - change of pain-related and concomitant pain medication during the course of the study
    - therapy with "Oxycodon-HCl beta, 1 x täglich Retardtabletten”:
    dose adjustments
    - eventual premature termination of the study
    - adverse events and adverse drug reactions which may have occurred
    - final evaluation of Oxycodon-HCl beta by the physician
    The patient will assess the intensity of pain and the corresponding impairment of everyday life using a questionnaire.

    The present observational study does not affect the individual course of medical treatment. Visits should only be performed if required from a medical and/or therapeutic point of view and within the context of the routine treatment with "Oxycodon-HCl beta, 1 x täglich Retardtabletten”.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

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.

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Secondary Outcome

-

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2013/10/10
  •   10000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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.

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Exclusion Criteria

no exclusion criteria

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Addresses

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    • betapharm Arzneimittel GmbH
    • Kobelweg 95
    • 86156  Augsburg
    • Germany
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    • betapharm Arzneimittel GmbH
    • Ms.  Dr. rer. nat.  Ulrike  Paulus 
    • Kobelweg 95
    • 86156  Augsburg
    • Germany
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    • betapharm Arzneimittel GmbH
    • Ms.  Dr. rer. nat.  Ulrike  Paulus 
    • Kobelweg 95
    • 86156  Augsburg
    • Germany
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Sources of Monetary or Material Support

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    • betapharm Arzneimittel GmbH
    • Kobelweg 95
    • 86156  Augsburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/01/30
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.