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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 4
18 Years
N/A
Not Enrolling
Both
Advanced Cancer, Opioid Use, Unspecified

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Pain reduction caused by paracetamol 4g/d

Outcome Description:

Pain reduction in the active paracetamol arm, compared to placebo, corrected for difference in rescue medication intake.

Outcome Time Frame:

Last day in each 3 days study period

Safety Issue:

Yes

Principal Investigator

Jan Henrik Rosland, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Haraldsplass Deaconess Hospital

Authority:

Norway: Norwegian Medicines Agency

Study ID:

Par 06-0045

NCT ID:

NCT01313247

Start Date:

April 2011

Completion Date:

December 2012

Related Keywords:

  • Advanced Cancer
  • Opioid Use, Unspecified
  • Paracetamol
  • opioids
  • cancer pain
  • Neoplasms

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