Not Yet RecruitingPhase 3Phase 4ACTRN12610000893000

A Single Patient Multiple Cross-Over Study To Determine The Efficacy Of Paracetamol In Relieving Pain Suffered By Patients With Advanced Cancer Taking Regular Opioids.


Sponsor

The University of Queensland

Enrollment

40 participants

Start Date

Nov 1, 2010

Study Type

Interventional

Conditions

Summary

The aim of this study is to determine the efficacy of paracetamol in relieving pain suffered by patients with advanced cancer taking regular opioids. It is hypothesised that 1. Paracetamol prescribed in addition to regular opioids will not improve analgesia compared to opioids alone in patients with pain from advanced cancer, and; 2. combining n-of-1 trials from multiple subjects provides a feasible variation on randomised controlled trials (RCTs) in palliative care (PC) to produce population evidence of high quality.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether paracetamol (acetaminophen) provides additional pain relief for cancer patients who are already taking strong pain medications. It is for adults aged 18 and older with chronic cancer pain that is reasonably well-controlled, who have normal liver function and can swallow medications.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The Intervention treatment will be SR paracetamol 665 mg tabs (encapsulated) to be taken orally with water. The patient will be randomly assigned to one drug. The patient will then be administerd t

The Intervention treatment will be SR paracetamol 665 mg tabs (encapsulated) to be taken orally with water. The patient will be randomly assigned to one drug. The patient will then be administerd the drug 3 to 4 times daily in a 3 day period. The drug will then be switched. The patient will then be administered the second drug 3 to 4 times daily for a 3 day period. The 6 day period is called a cycle. The cycle will be repeated 3 times. A washout period will be registered on the first day of each 3 day period. On these day, pain scores will not be included in the final analysis.


Locations(1)

Australia

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ACTRN12610000893000