Last updated: 01/27/2022 07:50:04

Analysis of medical treatment of mild to moderate pain – A register study on Danish data

GSK study ID
216934
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An analysis focusing on1)Identification and characterization of patients receiving treatment for mild to moderate pain2)an analysis of societal and health effects and costs associated with treatment using Panodil 665-a paracetamol formulation with modified release
Trial description: The aim of this analysis is to pool prescriptions data from Statistics Denmark for the years 2012-2018 to identify and characterize participants who were prescribed paracetamol, NSAIDs (Non Steroidal Anti-Inflammatory Drugs) or opioids to analyze the societal health effects and costs associated with using modified release paracetamol formulation (Panodil 665). The analysis is performed as a sequence analysis and gives a picture of which drugs the patients are started on and how they are changed over time..
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

To analyze the correlation between treatment with Panodil 665 (modified release paracetamol) versus paracetamol in patients with continued/long-term use of paracetamol

Timeframe: 3 months

To analyze the societal health effects and costs associated with using modified release paracetamol formulation (Panodil 665) versus paracetamol in patients with continued/long-term use of paracetamol

Timeframe: 3 months

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Paracetamol
  • Drug: Panodil 665 (modified release paracetamol)
  • Drug: NSAIDs + paracetamol
  • Drug: Opioids + paracetamol and NSAID
    • Enrollment:
    500000
    Primary completion date:
    2022-17-01
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Pain
    Product
    paracetamol
    Collaborators
    Not applicable
    Study date(s)
    June 2021 to January 2022
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 99 Years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • The inclusion criteria’s for the basis population are: 1) Danish citizen;2) Having a prescription for paracetamol preparations (ATC code: N02BE01), NSAIDs (ATC code: M01AE01 and N02BA) or opioids (ATC code: N02A and R05DA04) in the years 2014-2018.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • The inclusion criteria’s for the basis population are: 1) Danish citizen;2) Having a prescription for paracetamol preparations (ATC code: N02BE01), NSAIDs (ATC code: M01AE01 and N02BA) or opioids (ATC code: N02A and R05DA04) in the years 2014-2018.
    • The inclusion criteria’s for the course of treatment for the group are:1) Danish citizen; 2) Having a prescription for paracetamol preparations (ATC code: N02BE01), NSAIDs (ATC code: M01AE01 and N02BA) or opioids (ATC code: N02A R05DA04) in the year 2016.
    • The inclusion criteria’s for the correlation study intervention group are:1) Danish citizen; 2) Having a prescription for Panodil 665 identified using unique item number (varnr. 008453); 3)Having three prescriptions for paracetamol preparations (ATC code: N02BE01) with the first Panodil 665 prescription.
    • The inclusion criteria’s for the correlation study control group are:1)Danish citizen; 2) Having three prescriptions for paracetamol preparations (ATC code: N02BE01) Exclusion Criteria
    • The exclusion criteria’s for the basis population or for the course of treatment:Pregnancy (code-8110 in GP-catalog)
    • The exclusion criteria’s for the correlation analysis intervention group are:1) Any fulfilled prescription normally indicated for use in a psychiatric disorder in the study period (2012-2018) defined as Psycholeptics (ATC-code: N05) and Psychoanaleptics (ATC-code: N06); 2) Any fulfilled prescription for paracetamol with modified release 6 months prior (wash-out period) to the index date in 2013-2018.
    • The exclusion criteria’s for the correlation analysis control group are:1) Any fulfilled prescription targeted a psychiatric disorder in the study period (2012-2018) defined as Psycholeptics (ATC-code: N05) and Psychoanaleptics (ATC-code: N06); 2) Any fulfilled prescription of a paracetamol with modified release (Panodil 665 or Pinex Retard) identified using unique item number (varnr. 008453 ,084245 and 084256) .

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Recruitment complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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