Paracetamol for Cancer Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Haraldsplass Deaconess Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Haraldsplass Deaconess Hospital
ClinicalTrials.gov Identifier:
NCT01313247
First received: March 10, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Advanced Cancer
Opioid Use, Unspecified
Drug: paracetamol
Drug: placebo tablets
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Haraldsplass Deaconess Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 50
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)
Arms Assigned Interventions
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
Drug: paracetamol
1000 mg 4 times daily
Other Name: Acetaminophen

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313247

Contacts
Contact: Jan Henrik Rosland, MD, PhD +4755979400 ext 79387 jhro@haraldsplass.no
Contact: Sindre Hoel, MD +4755975000 sindre.hoel@gmail.com

Locations
Norway
Haraldsplass Deaconess Hospital Not yet recruiting
Bergen, Norway, 5009
Principal Investigator: Sindre Hoel, MD         
Sponsors and Collaborators
Haraldsplass Deaconess Hospital
Investigators
Principal Investigator: Jan Henrik Rosland, MD, PhD Haraldsplass Deaconess Hospital
  More Information

No publications provided

Responsible Party: Jan Henrik Rosland, professor, Haraldsplass Deaconess Hospital
ClinicalTrials.gov Identifier: NCT01313247     History of Changes
Other Study ID Numbers: Par 06-0045
Study First Received: March 10, 2011
Last Updated: March 10, 2011
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Haraldsplass Deaconess Hospital:
Paracetamol
opioids
cancer pain

Additional relevant MeSH terms:
Neoplasms
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014