Paracetamol Discontinuation in the Elderly After Long-term Consumption

NCT04523740 | Unknown

• 1 other identifier: 2019-000203-33
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate if long-term treatment of paracetamol can be discontinued without no worsening on pain, health-related quality-of-life and level of function compared to continuing paracetamol treatment in patients aged 65 years or more.

Conditions

Pain, Chronic; Pain, Medication; Pain, Discontinuation

Outcome Measures

Primary Outcomes (1)

• Visual analog scale (VAS) pain during til last 24 hours

  Comparison of changes in visual analog scale (VAS) pain intensity during the last 24 hours, from baseline value at week 2 between the control and intervention group. VAS is a 0-100 mm scale where 0 is "no pain" and 100 is "worst pain"

  Change from baseline value at week 2

Secondary Outcomes (9)

• EQ5D-5L index

  Change from baseline value at week 2

• Treatment failure.

  Week 2

• Grip strength

  Change from baseline value at week 2

• Sitting-rising test

  Change from baseline value at week 2

• Sum of daily visual analog scale (VAS) pain

  Sum from baseline to week 2

Study Arms (2)

Placebo replacement

EXPERIMENTAL

Participants will discontinue the paracetamol treatment, and be administered 6 to 8 tablets of placebo per day

Drug: Placebo

Usual care with paracetamol

ACTIVE COMPARATOR

Participants will continue the paracetamol treatment, and be administered 6 to 8 tablets of 500mg paracetamol per day

Drug: Paracetamol

Interventions

Placebo DRUG

Patients who use regular paracetamol will now receive 6 to 8 tablets of placebo per day for 2 weeks

Placebo replacement

Paracetamol DRUG

Patients who use regular paracetamol will now receive 6 to 8 tablets of 500 mg paracetamol per day for 2 weeks

Also known as: Acetaminophen

Usual care with paracetamol

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years or more
• Regular daily users of 3 to 4 grams of paracetamol for at least 6 months prior to enrollment

You may not qualify if:

• Malignant pain cf. their medical records
• 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.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Department of clinical pharmacology

Copenhagen, Bispebjerg, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jon T Andersen, MD, PhD

  Department of Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Vermehren, PhD

CONTACT

+45 3863 5209; Charlotte.Vermehren@regionh.dk

Lykke I Kaas Oldenburg

CONTACT

+45 38635807; lykke.ida.kaas.oldenburg@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Pharm, PhD candidate

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 24, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)