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
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2011
CompletedFirst Posted
Study publicly available on registry
March 11, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMarch 11, 2011
March 1, 2011
1.7 years
March 10, 2011
March 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain reduction caused by paracetamol 4g/d
Pain reduction in the active paracetamol arm, compared to placebo, corrected for difference in rescue medication intake.
Last day in each 3 days study period
Secondary Outcomes (1)
Overall satisfaction with the pain treatment
End of each 3 days study period
Study Arms (2)
Placebo pills
PLACEBO COMPARATORPlacebo tablets resembling paracetamol 500 mg are given as alternative 2 tablets 4 times daily
oral paracetamol 4 g daily
ACTIVE COMPARATORPatients are given 2 tablets of 500 mg paracetamol on a regular basis 4 times daily
Interventions
Placebo pills eqv paracetamol are given 2 tablets 4 times daily instead of paracetamol
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Haraldsplass Deaconess Hospital
Bergen, 5009, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Henrik Rosland, MD, PhD
Haraldsplass Deaconess Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 10, 2011
First Posted
March 11, 2011
Study Start
April 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
March 11, 2011
Record last verified: 2011-03