Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Pain

Pain Clinical Trial

— PaSO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02706769
• Other study ID #: AC15006
• Status: Terminated
• Phase: N/A
• Start date: November 25, 2016
• Est. completion date: May 2019

Study information

• Verified date: September 2019
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: May 2019
• Est. primary completion date: September 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Placebo
Study medication contains blinded placebo
• Paracetamol
Study medication contains blinded paracetamol

Locations

Country	Name	City	State
United Kingdom	Western General Hospital	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		14 days