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

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ClinicalTrials.gov Identifier: NCT02706769
Recruitment Status : Recruiting
First Posted : March 11, 2016
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Placebo Drug: Paracetamol Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Double-blind Randomised Parallel Group Trial of Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Related Pain
Actual Study Start Date : November 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02706769


Contacts
Contact: Lucy Norris 0131 651 8601 lucy.norris@ed.ac.uk
Contact: Marie Fallon 0131 651 8600 marie.fallon@ed.ac.uk

Locations
United Kingdom
Western General Hospital Recruiting
Edinburgh, United Kingdom, EH4 2XR
Contact: Marie Fallon    0131 651 8611    marie.fallon@ed.ac.uk   
Contact: Lucy Norris    0131 651 8601    lucy.norris@ed.ac.uk   
Sponsors and Collaborators
University of Edinburgh
NHS Lothian

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02706769     History of Changes
Other Study ID Numbers: AC15006
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics