Paracetamol for Cancer Pain
Recruitment status was Not yet recruiting
Randomised, double-blind placebo controlled cross-over trial
Optimize the medical pain treatment for patients with advanced cancer disease
Measure paracetamol's additional analgesic effect in a situation where the patient is concomitantly treated with oral opioids eqv. morphine > 100 mg/d.
Opioid Use, Unspecified
Drug: placebo tablets
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Pain reduction caused by paracetamol 4g/d [ Time Frame: Last day in each 3 days study period ] [ Designated as safety issue: Yes ]Pain reduction in the active paracetamol arm, compared to placebo, corrected for difference in rescue medication intake.
- Overall satisfaction with the pain treatment [ Time Frame: End of each 3 days study period ] [ Designated as safety issue: No ]Total ESAS score Sweating during nighttime general wellbeing
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo pills
Placebo tablets resembling paracetamol 500 mg are given as alternative 2 tablets 4 times daily
Drug: placebo tablets
Placebo pills eqv paracetamol are given 2 tablets 4 times daily instead of paracetamol
Other Name: Suger pills
Active Comparator: oral paracetamol 4 g daily
Patients are given 2 tablets of 500 mg paracetamol on a regular basis 4 times daily
1000 mg 4 times daily
Other Name: Acetaminophen
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313247
|Contact: Jan Henrik Rosland, MD, PhD||+4755979400 ext firstname.lastname@example.org|
|Contact: Sindre Hoel, MDemail@example.com|
|Haraldsplass Deaconess Hospital||Not yet recruiting|
|Bergen, Norway, 5009|
|Principal Investigator: Sindre Hoel, MD|
|Principal Investigator:||Jan Henrik Rosland, MD, PhD||Haraldsplass Deaconess Hospital|