Paracetamol Discontinuation in the Elderly after long-term consumption (PARADISE)

Phase 1

• Conditions: MedDRA version: 20.1Level: LLTClassification code 10049475Term: Chronic painSystem Organ Class: 100000004867; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2019-000203-33-DK
• Lead Sponsor: Klinisk Farmakologisk Afdeling

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-04
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

a.Inclusion criteria
Patients aged 65 years or above, who for at least 6 months prior to enrollment have received paracetamol as prescribed daily regular medication of 3 to 4 grams.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 132

Exclusion Criteria

b.Exclusion criteria
?Malignant pain cf. their medical records
?Patients using other regular analgesics
?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
?MMSE score less than 25

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified