Paracetamol for Cancer Pain
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|