MedDRA version: 20.1 Level: LLT Classification code 10049475 Term: Chronic pain System Organ Class: 100000004867
Conditions
Interventions
Trade Name: Arax
Product Name: Paracetamol
Pharmaceutical Form: Tablet
INN or Proposed INN: Paracetamol
Other descriptive name: PARACETAMOL
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
Klinisk Farmakologisk Afdeling
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall, this trial is conducted to investigate if paracetamol used as long-term treatment can be discontinued without changes in pain conditions, level of function, and quality of life. Assessment of the effects of paracetamol during long-term treatment will indicate if this treatment is rational or not. The objective of study 1 is to investigate the impact of discontinuing a long-term paracetamol treatment in elderly patients by performing a randomized controlled trial where paracetamol will be discontinued. This will mainly be assessed by investigating the progress of pain condition during the treatment period as well as the health-related quality of life and level of function. ;Secondary Objective: The objectives of study 2 are to evaluate the participants’ need for paracetamol after ending the treatment period and after unblinding of the participants. This is done by reviewing the participants consumption of paracetamol, changes in other analgesics, and if there are any consequences of paracetamol discontinuation, such as an increase in falling accidents and hospitalizations. ;Primary end point(s): Endpoints for study 1 Primary Visual analog scale (VAS) pain intensity Endpoints for study 2 Primary Number of regular users (3 grams of paracetamol or more) since ending treatment period. ;Timepoint(s) of evaluation of this end point: When trial period for study 1 is over for all participants the data will be analysed and endpoints evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): For study 1: Secondary The European Quality of Life-5 Dimensions Index (EQ-5D-5L) Treatment failure. Defined as initiating other regular analgesics; or withdrawal. Functional test: 6-meter walking test, grip strength, and sitting-rising test For study 2: Secondary VAS pain intensity EQ-5D-5L Treatment failure: Number of participants who initiated regular use of other analgesics ;Timepoint(s) of evaluation of this end point: When trial period for study 2 is over for all participants the data will be analysed and endpoints evaluated. | — |
Countries
Denmark
Contacts
Public ContactLykke Ida Kaas-Rasmussen Olsen
Klinisk Farmakologisk Afdeling
Outcome results
None listed