NCT05051735

PARASTOP - Paracetamol With Strong Opioids

PARASTOP - Paracetamol With Strong Opioids. A Randomized, Double-blind, Parallel-group Non-inferiority Phase III Withdrawal Trial of Paracetamol Versus Placebo in Conjunction With Opioids for Moderate to Severe Cancer-related Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Current guidelines recommend all people with cancer-related pain should be prescribed paracetamol, even those receiving high doses of strong pain killers (opioids) such as morphine. Although this has been shown in studies to be beneficial in other conditions, for instance dental work and after surgery, it has not been shown to further improve pain in people with cancer-related pain. Taking tablets is burdensome to patients and the study aims to determine whether the inconvenience of taking eight extra paracetamol tablets per day can be justified. The study plans to show whether or not pain control is changed (non-inferior) when stopping paracetamol compared to continued use of paracetamol in people already taking strong pain killers for cancer-related pain. Voluntary participants who are taking a combination of paracetamol and a strong opioid are recruited to the study.

Conditions

• Cancer Pain
• Cancer

Interventions

Type	Name	Description
DRUG	Paracetamol	Paracetamol 500 mg
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-10-20
• Primary completion: 2026-02-11
• Completion: 2026-02-18
• First posted: 2021-09-21
• Last updated: 2026-02-25

Locations

15 sites across 4 countries: Italy, Norway, Uganda, United Kingdom