NCT05088876

Brief Summary

Blinded withdrawal of regular co-medication with paracetamol in chronic pain patients under strong opioids on pain control.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Aug 2024

Typical duration for phase_4 pain

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
2.9 years until next milestone

Study Start

First participant enrolled

August 28, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

October 5, 2021

Last Update Submit

April 7, 2026

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • VAS score (average pain intensity)

    Study day 7

Secondary Outcomes (31)

  • Average pain using the Brief Pain Inventory (BPI)

    On each study day, up to 14 days

  • Minimum pain using the Brief Pain Inventory (BPI)

    On each study day, up to 14 days

  • Worst pain using the Brief Pain Inventory (BPI)

    On each study day, up to 14 days

  • Current pain using the Brief Pain Inventory (BPI)

    On each study day, up to 14 days

  • Average pain using the Brief Pain Inventory (BPI)

    During the last four days of each study phase (days 4-7 und 11-14)

  • +26 more secondary outcomes

Study Arms (2)

Paracetamol

ACTIVE COMPARATOR
Drug: Paracetamol

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

Blinded withdrawal of regular co-medication with paracetamol

Placebo
ParacetamolDRUG

Paracetamol in the dose already used

Paracetamol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients receiving a WHO step III opioid (i.e. morphine, oxycodone, methadone, fentanyl, hydromorphone, or buprenorphine) in combination with paracetamol (minimum dose 1.5 g/day)
  • Age ≥ 18 at screening
  • Ability to understand the study procedures and to provide written informed consent
  • Stable analgesia before randomisation, defined as no required changes in the analgesic treatment during the previous 7 days

You may not qualify if:

  • Participation in another interventional trial within 30 days prior to randomisation, with the exception of cancer treatment trials
  • Changes of the dosage or start of other (co-)analgesics (e.g. tricyclic antidepressants, neuroleptics, nonsteroidal anti-inflammatory drugs (NSAIDs), dipyrone), within the last 7 days preceding randomisation
  • Surgery within the 14 days preceding randomisation or surgery planned within the duration of the study
  • Any circumstances, comorbidities or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kantonsspital Baden

Baden, Switzerland

Location

Inselspital, Bern University Hospital

Bern, Switzerland

Location

Related Publications (1)

  • Kotoula C, Wertli MM, Streitberger K, Rothschild SI, Limacher A, Hammann F, Krahenbuhl S, Haschke M, Liakoni E. Efficacy of paracetamol added to WHO step III opioids in chronic pain control: study protocol for a randomised, double-blind, placebo-controlled, non-inferiority, multicentre study in Switzerland. BMJ Open. 2025 Dec 31;15(12):e107360. doi: 10.1136/bmjopen-2025-107360.

    PMID: 41475826DERIVED

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Evangelia Liakoni

    Inselspital, Bern University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2021

First Posted

October 22, 2021

Study Start

August 28, 2024

Primary Completion

March 5, 2026

Study Completion

March 5, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Data that relates to individual, primary publications (and not the whole study database as such) will be deposited in the Bern Open Repository and Information System (BORIS). All efforts will be made to protect privacy and to de-identify the data. Data will be shared on request under the following conditions: A meaningful study question by the requester, outline of the planned analyses, valid methodology, signed data sharing agreement that contains a confidentiality agreement in case of sensitive data.

More information

Locations

CH(2)