Paracetamol Discontinuation in the Elderly After Long-term Consumption
NCT ID: NCT04523740
Last Updated: 2020-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
98 participants
INTERVENTIONAL
2020-08-31
2021-12-31
Brief Summary
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Detailed Description
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Trial design: Patients are randomized to either arm 1: standard care (paracetamol continuation) or arm 2: experimental treatment (placebo).
The investigation is double-blinded.
Patients are screened and recruited from Department of respiratory medicine at Copenhagen University Hospital Bispebjerg. Patients with a daily consumption of 3 grams or more of prescribed paracetamol and who comply with the other eligibility criteria will be invited to participate in the trial and asked for written, informed consent. If given we collect data regarding the patient's medications, any medication changes during the intervention and followup, frailty (FRAIL Scale), self-reported history of falls, recent admissions, self-reported health-related quality of life (EQ-5D-5L), level of function tested by hand grib strength and sitting-rising test, and death.
Data is collected at baseline and after 2 weeks when ending treatment intervention, and a 26 week follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
QUADRUPLE
Study Groups
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Placebo replacement
Participants will discontinue the paracetamol treatment, and be administered 6 to 8 tablets of placebo per day
Placebo
Patients who use regular paracetamol will now receive 6 to 8 tablets of placebo per day for 2 weeks
Usual care with paracetamol
Participants will continue the paracetamol treatment, and be administered 6 to 8 tablets of 500mg paracetamol per day
Paracetamol
Patients who use regular paracetamol will now receive 6 to 8 tablets of 500 mg paracetamol per day for 2 weeks
Interventions
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Placebo
Patients who use regular paracetamol will now receive 6 to 8 tablets of placebo per day for 2 weeks
Paracetamol
Patients who use regular paracetamol will now receive 6 to 8 tablets of 500 mg paracetamol per day for 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Regular daily users of 3 to 4 grams of paracetamol for at least 6 months prior to enrollment
Exclusion Criteria
* Patients using other regular analgesics cf. indication on prescription
* Patients receiving paracetamol tablets with modified release or sustained release
* Patients in warfarin treatment
* Patients with terminal illnesses, cf. their medical records.
* Patients receiving dosages dispensed by their pharmacy
* Mini-Mental State Examination (MMSE) score less than 25
* Patients with or suspected to have COVID-19.
65 Years
ALL
No
Sponsors
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University Hospital Bispebjerg and Frederiksberg
OTHER
Responsible Party
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Lykke Ida Kaas Oldenburg
MSc Pharm, PhD candidate
Principal Investigators
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Jon T Andersen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Pharmacology
Locations
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Department of clinical pharmacology
Copenhagen, Bispebjerg, Denmark
Countries
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Central Contacts
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Other Identifiers
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2019-000203-33
Identifier Type: -
Identifier Source: org_study_id
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