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PARASTOP - Paracetamol with Strong Opioids
EU CTIS ID: 2024-515012-53-00
What this study is testing
The main objective is to investigate whether withdrawal of paracetamol when used together with strong opioids provides inferior pain control compared to continuous use of paracetamol together with strong opioids.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent.
- Able to take study drug/placebo as tablets
- Able to take study drug/placebo as tablets
- Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent.
- Participants who are under palliative care or oncology service review
You likely can't join if
- History of allergy or hypersensitivity to any of the active substances or excipients in the study drug
- Known severe liver or renal failure equivalent with CTCAE Grade 3 or 4* precluding continuation of paracetamol. (*Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0)
- Participants receiving subcutaneous, intravenous, intrathecal, or epidural opioid therapy
- Participants receiving systemic anticancer treatment during the intervention period if they are anticipated to have increasing pain or other symptoms related to the treatment
- Co-enrolment in other drug trials. Participants will not be enrolled in any other ongoing interventional clinical trial. Study participants may be enrolled in noninterventional research (e.g. questionnaire, tissue collection studies)
- Previously enrolled in this study
See the full eligibility criteria
- Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent.
- Able to take study drug/placebo as tablets
- Able to take study drug/placebo as tablets
- Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent.
- Participants who are under palliative care or oncology service review
- Diagnosis of metastatic cancer. This includes all incurable solid malignancy in an advanced stage, either locally advanced or metastatic. This also includes malignant lymphoma in the palliative setting and multiple myeloma with bone disease.
- Clinician-predicted life expectancy >2 months
- Receiving daily regular strong opioids for cancer pain
- Receiving stable scheduled opioid dose last 48 hours
- Receiving paracetamol 1 gram x three or four times a day for at least five days
- Average pain intensity past 24 hours ≥ 2 and ≤ 7 (NRS 0-10)
- History of allergy or hypersensitivity to any of the active substances or excipients in the study drug
- Known severe liver or renal failure equivalent with CTCAE Grade 3 or 4* precluding continuation of paracetamol. (*Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0)
- Participants receiving subcutaneous, intravenous, intrathecal, or epidural opioid therapy
- Participants receiving systemic anticancer treatment during the intervention period if they are anticipated to have increasing pain or other symptoms related to the treatment
- Co-enrolment in other drug trials. Participants will not be enrolled in any other ongoing interventional clinical trial. Study participants may be enrolled in noninterventional research (e.g. questionnaire, tissue collection studies)
- Previously enrolled in this study
- Pregnant or lactating women
The study team makes the final eligibility decision.
Where it's taking place
- Uganda
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Uganda. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.