A Phase 4 interventional study of paracetamol and placebo tablets in Advanced Cancer and Opioid Use, Unspecified, sponsored by Haraldsplass Deaconess Hospital. Status unknown at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-11.
Sponsored by Haraldsplass Deaconess Hospital · Phase 4, Interventional, and Treatment
Randomised, double-blind placebo controlled cross-over trial
Main goal:
Optimize the medical pain treatment for patients with advanced cancer disease
Study goal:
Measure paracetamol's additional analgesic effect in a situation where the patient is concomitantly treated with oral opioids eqv. morphine > 100 mg/d.
National multicenter study with an intention to include 50 patients. 6 days treatment, 3d in each arm. Mean pain score last 24 h: NRS =/> 4 All drug treatment constant during the study period. The participants are allowed to take as much rescue opioids as necessary to have adequate relief.
Paracetamol/ placebo given orally 1000 mg x 4 daily, three days in each arm, direct crossover.
Daily scoring of pain relief, ESAS, overall satisfaction and rescue medication.
338 studies on the registry are indexed under Cancer Pain; 71 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 254 interventional studies indexed under Cancer Pain.
Browse Cancer Pain studies →Haraldsplass Deaconess Hospital is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo tablets resembling paracetamol 500 mg are given as alternative 2 tablets 4 times daily
Drug: placebo tablets
Patients are given 2 tablets of 500 mg paracetamol on a regular basis 4 times daily
Drug: paracetamol
1000 mg 4 times daily
Also known as: Acetaminophen
Placebo pills eqv paracetamol are given 2 tablets 4 times daily instead of paracetamol
Also known as: Suger pills
Pain reduction caused by paracetamol 4g/d
Pain reduction in the active paracetamol arm, compared to placebo, corrected for difference in rescue medication intake.
Time frame: Last day in each 3 days study period
Overall satisfaction with the pain treatment
Total ESAS score Sweating during nighttime general wellbeing
Time frame: End of each 3 days study period
This study is status unknown, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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Haraldsplass Deaconess Hospital