Trial document




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  DRKS00010280

Trial Description

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Title

Targin® for Treatment of Parkinson's disease associated severe pain - Efficacy and tolerability in real life

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Trial Acronym

TIPAS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The present non-interventional study will be conducted to investigate the efficacy of Targin® in patients with severe, chronic PD-related pain in an unselected, community-based patient population in a real life setting (office-based neurologists) with regard to pain intensity, and pain related impairment. The effect of Targin® on patient's motor symptoms as well as on non-motor symptoms and sleep will be recorded.

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Brief Summary in Scientific Language

The present non-interventional study will be conducted to investigate the efficacy of Targin® in patients with severe, chronic PD-related pain in an unselected, community-based patient population in a real life setting (office-based neurologists) with regard to pain intensity, and pain related impairment.
Objectives of main interest:
• Efficacy of Targin® on Parkinson’s disease associated pain intensity assessed using the numeric rating scale (NRS) for clinical pain measurement. Pain on average scores (item 5 of the Brief Pain Inventory Short Form [BPI-SF]) will be compared between baseline and the control visit after 8-12 weeks of treatment.
• Responder rate: Percentage of patients with ≥ 30% reduction in average pain score of NRS under treatment with Targin®.
• Characterization of patient population: King’s Parkinson’s disease pain scale (KPPS) to identify and grade the various types of pain in Parkinson’s disease at baseline.

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Organizational Data

  •   DRKS00010280
  •   2016/04/08
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  •   no
  •   Approved
  •   FF 149/2015, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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Health Condition or Problem studied

  •   PARKINSONASSOZIIERTERSCHMERZ
  •   G20 -  Parkinson disease
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Interventions/Observational Groups

  •   The observation will be performed in patients who suffer from idiopathic Parkinson's disease stage 1-5 according to Hoehn & Yahr and who suffer from severe Parkinson-associated pain which can be adequately managed only with opiod analgesics.
    Observation of pain intensity, and pain related impairment. The effect of Targin® on patient's motor symptoms as well as on non-motor symptoms and sleep will be recorded.
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Characteristics

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

Objectives of main interest:
• Efficacy of Targin® on Parkinson’s disease associated pain intensity assessed using the numeric rating scale (NRS) for clinical pain measurement. Pain on average scores (item 5 of the Brief Pain Inventory Short Form [BPI-SF]) will be compared between baseline and the control visit after 8-12 weeks of treatment.
• Responder rate: Percentage of patients with ≥ 30% reduction in average pain score of NRS between baseline and the control visit after 8-12 weeks under treatment with Targin®.
• Characterization of patient population: King’s Parkinson’s disease pain scale (KPPS) to identify and grade the various types of pain in Parkinson’s disease at baseline.

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Secondary Outcome

Efficacy of Targin® on the following parameters (values will be compared between baseline and the control visit):
• Efficacy of Targin® on PD-associated pain severity calculated from the 4 pain severity items (pain at worst, pain at least, pain on average, pain right now) assessed by the BPI-SF with an 11-point NRS for each item.
• Efficacy of Targin® on pain relief experienced by the patient within the last 24 hours assessed by BPI-SF item 8.
• Efficacy of Targin® on severity and frequency of various types of pain assessed by KPPS. Scores of the different pain domains will be compared between baseline and the control visit after 8-12 weeks of treatment.
• Efficacy of Targin® on patient’s daily activity assessed by item 9 of the BPI-SF and on quality of life assessed with the Parkinson’s Disease Questionnaire (PDQ-8).
• Influence of Targin® on motor symptoms documented by the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III: Motor examination.
• Influence of Targin® on non-motor symptoms assessed by the Non-Motor Symptoms assessment scale for Parkinson’s disease (NMSScale).
• Influence of Targin® on quality of sleep documented by Parkinson’s disease sleep scale (PDSS-2).
Tolerance of Targin® will be conducted based on the following parameters:
• Number, intensity and severity of adverse events as well as number and frequency of affected patients
• Assessment of tolerance by the physician after 8 - 12 weeks of treatment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2016/05/18
  •   300
  •   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

• Male and female patients aged ≥ 18 years.
• patients who suffer from diopathic Parkinson's disease stage 1-5 according to Hoehn & Yahr.
• patients who suffer from severe pain graded in at least 1 question of 1 domain of the King’s Parkinson’s disease pain scale (KPPS) which can, according to the physicians opinion, only adequately be managed with opioid analgesics,
• patients without contraindication (s) for treatment with Targin® according to summary of product characteristics (SmPC)
• patients who are not cognitively impaired and able to understand the purpose and importance of the study and complete the questionnaire.
• patients who were not treated with opioid analgesics within the last 3 months before enrolment
• patients who give their written consent for study participation and for data privacy policy

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Exclusion Criteria

The Observation should not be performed in pregnant women or nursing women as well as women willing to become pregnant during treatment.

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Addresses

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    • Mundipharma GmbH
    • Mundipharma Straße 2
    • 65549  Limburg (Lahn)
    • Germany
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    • Mundipharma GmbH
    • Ms.  Dr.  Tanja  Schmidt 
    • Mundipharma Straße 2
    • 65549  Limburg
    • Germany
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    • ANFOMED GmbH
    • Ms.  Sandra  Höpfert 
    • Röttenbacher Straße 17
    • 91096  Möhrendorf
    • Germany
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Sources of Monetary or Material Support

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    • Mundipharma GmbH
    • Mundipharma Straße 2
    • 65549  Limburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/01/04
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Trial Publications, Results and other Documents

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