Paracetamol for Cancer Pain

March 10, 2011 updated by: Haraldsplass Deaconess Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5009
        • Haraldsplass Deaconess Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Acetaminophen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Last day in each 3 days study period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall satisfaction with the pain treatment
Time Frame: End of each 3 days study period
Total ESAS score Sweating during nighttime general wellbeing
End of each 3 days study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haraldsplass Deaconess Hospital

Investigators

  • Principal Investigator: Jan Henrik Rosland, MD, PhD, Haraldsplass Deaconess Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

March 10, 2011

First Submitted That Met QC Criteria

March 10, 2011

First Posted (Estimate)

March 11, 2011

Study Record Updates

Last Update Posted (Estimate)

March 11, 2011

Last Update Submitted That Met QC Criteria

March 10, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Par 06-0045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Cancer

Clinical Trials on placebo tablets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe