Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT05051735
Eligibility Criteria:
Inclusion Criteria:
* Participants must be ≥ 18 years of age inclusive, at the time of signing the informed consent.
* ≥50 kg (due to paracetamol dosage)
* Participants who are under palliative care or oncology service review
* Diagnosis of metastatic cancer
* 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)\*
* Able to take study drug/placebo as tablets
* Able to comply with all study procedures
* 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.
* It is allowed to repeat procedure within the screening period without considering the participant being a rescreen
Exclusion Criteria:
* 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 on-going interventional clinical trial. Study participants may be enrolled in non-interventional research (e.g. questionnaire, tissue collection studies)
* Previously enrolled in this study
* Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05051735
Study Brief:
Protocol Section:
NCT05051735