Trial | NCT01313247  Report issue

Title

Paracetamol for Cancer Pain
Optimizing Medication for Cancer Pain. The Effect of Paracetamol. A Clinical and Pharmacological Trial to Research Whether Paracetamol Gives an Additional Effect on Pain Relief When the Patient is Treated With High Doses of Opioids

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    acetaminophen ...

  • Study Participants

    50
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.
Study Started
Apr 30
2011
Primary Completion
Dec 31
2012
Anticipated
Study Completion
Dec 31
2012
Anticipated
Last Update
Mar 11
2011
Estimate

Drug paracetamol

1000 mg 4 times daily

  • Other names: Acetaminophen

Drug placebo tablets

Placebo pills eqv paracetamol are given 2 tablets 4 times daily instead of paracetamol

  • Other names: Suger pills

Placebo pills Placebo Comparator

Placebo tablets resembling paracetamol 500 mg are given as alternative 2 tablets 4 times daily

oral paracetamol 4 g daily Active Comparator

Patients are given 2 tablets of 500 mg paracetamol on a regular basis 4 times daily

Criteria 

Inclusion Criteria:

Adults (> 18 years) of both sexes
Diagnosed with advanced cancer disease
Ongoing medicinal pain relief treatment in stable dosing with oral opiates equivalent to > 100 mg oral morphine daily
NRS median pain score last 24 hrs > 4
Able to take tablets (paracetamol) orally

Exclusion Criteria:

Mental or physical deficiency precluding data collection.
Reduced liver function judged with bilirubin, INR and transaminases
Anticoagulation with warfarin
Ongoing use of NSAIDs or 5-HT3 antagonists, or use of such drugs last week
Ongoing palliative radiation treatment or radiation treatment during the last 4 weeks.
No Results Posted