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

U

University of Edinburgh

Status

Terminated

Conditions

Pain

Treatments

Drug: Paracetamol
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02706769
AC15006

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

34 participants in 2 patient groups, including a placebo group

Paracetamol
Active Comparator group
Description:
Participants will take blinded Paracetamol (as they were taking before entering the study)
Treatment:
Drug: Paracetamol
Placebo
Placebo Comparator group
Description:
Participants will take blinded Paracetamol
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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