Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
204 participants
INTERVENTIONAL
2021-10-20
2026-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Paracetamol
Paracetamol P.O. 500 mg 2 tablets four times a day for 7 days
Paracetamol
Paracetamol 500 mg
Placebo
Placebo P.O. 2 tablets four times a day for 7 days
Placebo
Placebo
Interventions
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Paracetamol
Paracetamol 500 mg
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥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
* 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
18 Years
ALL
No
Sponsors
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Sykehuset Telemark
OTHER_GOV
Oslo University Hospital
OTHER
Responsible Party
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Ørnulf Paulsen
Senior Consultant
Principal Investigators
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Ørnulf Paulsen
Role: PRINCIPAL_INVESTIGATOR
Telemark Hospital Trust
Locations
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Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Vestre Viken Hospital Trust
Drammen, Drammen, Norway
Førde Hospital Trust
Førde, Førde, Norway
Østfold Hospital Trust
Sarpsborg, Grålum, Norway
Sørlandet Hospital Trust
Kristiansand, Kristiansand, Norway
Stavanger University Hospital
Stavanger, Stavanger, Norway
Helse Møre og Romsdal
Ålesund, , Norway
Akershus University Hospital
Lørenskog, , Norway
OsloUH
Oslo, , Norway
Telemark Hospital Trust
Skien, , Norway
Universitetssykehuset Nord-Norge
Tromsø, , Norway
St. Olavs Hospital
Trondheim, , Norway
Vestfold Hospital trust
Tønsberg, , Norway
Makere University Hospital
Kampala, , Uganda
Edinburgh Cancer Research
Edinburgh, , United Kingdom
Countries
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Other Identifiers
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180946
Identifier Type: -
Identifier Source: org_study_id
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