Clinical trial · Interventional
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
NCT05088876CI-TRIAL-00107916ParOPterminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment difficulties
Summary
Brief summary (as posted)
Blinded withdrawal of regular co-medication with paracetamol in chronic pain patients under strong opioids on pain control.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paracetamol | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Paracetamol
- interventionNames
- Drug: Paracetamol
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- VAS score (average pain intensity)
- timeFrame
- Study day 7
Secondary outcomes (31)
- measure
- Average pain using the Brief Pain Inventory (BPI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (1)
- DERIVEDKotoula 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 41475826