A double-blind, randomised parallel group trial of paracetamol versus placebo in conjunction with strong opioids for cancer related pain.
- Conditions
- Cancer related pain.MedDRA version: 20.0Level: LLTClassification code 10069398Term: Breakthrough cancer painSystem Organ Class: 100000004867MedDRA version: 20.0Level: PTClassification code 10058019Term: Cancer painSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-000197-38-GB
- Lead Sponsor
- niversity of Edinburgh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 280
1.Age 16 years and over
2.Diagnosis of incurable cancer
3.Clinician-predicted life expectancy > 2 months
4.Anticipated to be clinically stable for duration study involvement
5.Receiving daily regular strong opioids
6.Able to take study drug/placebo in its current form
7. Prescribed and taking paracetamol 1g four times a day
8.Average pain >=2 and <=8 in past 24 hours
9.Able to provide written informed consent
10.Able to complete necessary assessments required as part of the trial
11.Average pain score stable (ie maximum range 1 point) for 3 consecutive days prior to randomisation
Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 119
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160
1.Pain which the clinician deems to be unstable
2.Clinically significant renal or liver disease
3.Weight less than 50kg
4.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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish whether paracetamol in combination with strong opioids provides superior analgesia for cancer related pain over strong opioids alone. ;Secondary Objective: To establish whether paracetamol in combination with strong opioids changes opioid requirements, opioid side effects or distress levels compared to strong opioids alone.;Primary end point(s): The proportion of participants with a clinically relevant change in average pain score (defined as a minimum 2 point difference) between baseline and end of study, in the active drug group versus placebo.;Timepoint(s) of evaluation of this end point: Day 8.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change in opioid requirements - day 8<br>Change in opioid side effect score - day 8<br>Change in global distress score - day 8<br>Medication additions for uncontrolled pain during the study - day 8<br><br>Change in BPI scores - day 8<br><br>Withdrawal from study<br>Serious adverse events<br>;Timepoint(s) of evaluation of this end point: 8 days as indicated