Paracetamol for Cancer Pain
|ClinicalTrials.gov Identifier: NCT01313247|
Recruitment Status : Unknown
Verified March 2011 by Haraldsplass Deaconess Hospital.
Recruitment status was: Not yet recruiting
First Posted : March 11, 2011
Last Update Posted : March 11, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer Opioid Use, Unspecified||Drug: paracetamol Drug: placebo tablets||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
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
- Pain reduction caused by paracetamol 4g/d [ Time Frame: Last day in each 3 days study period ]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 ]Total ESAS score Sweating during nighttime general wellbeing
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|