PainPaSONCT02706769
Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Pain
A study testing Paracetamol in people with Pain, run by University of Edinburgh at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Paracetamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Nov 2016to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 16 years and over
- Under palliative care/oncology service review
- Diagnosis of incurable cancer
- Clinician-predicted life expectancy >2 months
- Anticipated to be clinically stable for duration of study involvement
- Receiving daily regular strong opioids
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- Able to take study drug/placebo in its current form
- Prescribed and taking paracetamol 1g four times a day
- Average pain >3 and <9 in past 24 hours
- Able to provide written informed consent
- Able to complete necessary assessments required as part of the trial
- Average NRS pain score stable (ie. maximum range of 1 point) for the three consecutive days prior to randomisation
Who cannot join
- Pain which the clinician deems to be unstable
- Clinically significant renal or liver disease
- Weight less than 50kg
- Those whose pain is expected to change during the course of the study as a result of oncological or other treatments
- Co-enrolment in other drug trials
- Known to be pregnant or breast-feeding at the time of recruitment
- Previously enrolled in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pain
- Being tested
- Placebo, Paracetamol
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Study medication contains blinded placebo
ParacetamolDrug
Study medication contains blinded paracetamol
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Active comparator | Participants will take blinded Paracetamol (as they were taking before entering the study) Receives: Drug: Paracetamol |
| Placebo | Placebo comparator | Participants will take blinded Paracetamol Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study start25 Nov 2016
- Primary completion4 Sep 2018
- Study completionMay 2019
Why it stopped: Funding was terminated early due to slow recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706769
- Sponsor's protocol ID
- AC15006
- Acronym
- PaSO
- Status last verified
- Sep 2019
- First submitted
- 25 Jan 2016
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomised Parallel Group Trial of Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Related Pain
- ClinicalTrials.gov ID
- NCT02706769
- Acronym / sponsor ID
- PaSO / AC15006
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding was terminated early due to slow recruitment.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 25 Nov 2016 (actual)
- Primary completion
- 4 Sep 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 11 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Active comparator | Drug: ParacetamolParticipants will take blinded Paracetamol (as they were taking before entering the study) |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will take blinded Paracetamol |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Age 16 years and over
- Under palliative care/oncology service review
- Diagnosis of incurable cancer
- Clinician-predicted life expectancy >2 months
- Anticipated to be clinically stable for duration of study involvement
Key exclusion criteria (7 listed)
- Pain which the clinician deems to be unstable
- Clinically significant renal or liver disease
- Weight less than 50kg
- Those whose pain is expected to change during the course of the study as a result of oncological or other treatments
- Co-enrolment in other drug trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboStudy medication contains blinded placebo | Drug | Placebo |
| ParacetamolStudy medication contains blinded paracetamol | Drug | Paracetamol |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Funding was terminated early due to slow recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol in people with Pain, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding was terminated early due to slow recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.