RecruitingPhase 4NCT05088876
Paracetamol in Addition to WHO Step III Opioids in Chronic Cancer Pain Control
Paracetamol in Addition to WHO Step III Opioids in Chronic Cancer Pain Control - a Randomized, Double-blind, Placebo-controlled, Non-inferiority Study
Sponsor
Insel Gruppe AG, University Hospital Bern
Enrollment
140 participants
Start Date
Aug 28, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
Blinded withdrawal of regular co-medication with paracetamol in chronic pain patients under strong opioids on pain control.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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
Exclusion Criteria4
- 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
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Interventions
DRUGPlacebo
Blinded withdrawal of regular co-medication with paracetamol
DRUGParacetamol
Paracetamol in the dose already used
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05088876
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