Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Pain (PaSO)

September 25, 2019 updated by: University of Edinburgh

A Double-blind Randomised Parallel Group Trial of Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Related Pain

National guidelines advocate the use of paracetamol in conjunction with strong opioids for cancer pain, despite a lack of evidence for its efficacy. Work is needed to examine the analgesic benefit of paracetamol in this large patient group. The investigators aim to establish if paracetamol in combination with strong opioids provides superior analgesia for cancer related pain over strong opioids alone.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

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

  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XR
        • Western General 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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 16 years and over
  2. Under palliative care/oncology service review
  3. Diagnosis of incurable cancer
  4. Clinician-predicted life expectancy >2 months
  5. Anticipated to be clinically stable for duration of study involvement
  6. Receiving daily regular strong opioids
  7. Able to take study drug/placebo in its current form
  8. Prescribed and taking paracetamol 1g four times a day
  9. Average pain >3 and <9 in past 24 hours
  10. Able to provide written informed consent
  11. Able to complete necessary assessments required as part of the trial
  12. Average NRS pain score stable (ie. maximum range of 1 point) for the three consecutive days prior to randomisation

Exclusion Criteria:

  1. Pain which the clinician deems to be unstable
  2. Clinically significant renal or liver disease
  3. Weight less than 50kg
  4. Those whose pain is expected to change during the course of the study as a result of oncological or other treatments
  5. Co-enrolment in other drug trials
  6. Known to be pregnant or breast-feeding at the time of recruitment
  7. Previously enrolled in this study

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Paracetamol
Participants will take blinded Paracetamol (as they were taking before entering the study)
Drug: Paracetamol
Study medication contains blinded paracetamol
Placebo Comparator: Placebo
Participants will take blinded Paracetamol
Drug: Placebo
Study medication contains blinded placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants with a 30% increase in total Brief Pain Inventory between day 0 and day 14 in the active drug group versus the placebo group.
Time Frame: 14 days
14 days

Collaborators and Investigators

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

Sponsor

University of Edinburgh

Collaborators

NHS Lothian

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 (Actual)

November 25, 2016

Primary Completion (Actual)

September 4, 2018

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

March 7, 2016

First Posted (Estimate)

March 11, 2016

Study Record Updates

Last Update Posted (Actual)

September 27, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC15006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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 Pain

Clinical Trials on Paracetamol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe