Advanced CancerPhase 4NCT01313247
Paracetamol for Cancer Pain
A Phase 4 study testing paracetamol in people with Advanced Cancer and Opioid Use, Unspecified, run by Haraldsplass Deaconess Hospital at 1 site in Norway.
Trial summary
Randomised, double-blind placebo controlled cross-over trial Main goal: Optimize the medical pain treatment for patients with advanced cancer disease Study goal: Measure paracetamol's additional analgesic effect in a situation where the patient is concomitantly treated with oral opioids eqv. morphine > 100 mg/d. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Opioid Use, Unspecified
- What is being tested?
- paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2011to Dec 2012
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (> 18 years) of both sexes
- Diagnosed with advanced cancer disease
- Ongoing medicinal pain relief treatment in stable dosing with oral opiates equivalent to > 100 mg oral morphine daily
- NRS median pain score last 24 hrs > 4
- Able to take tablets (paracetamol) orally
Who cannot join
- Mental or physical deficiency precluding data collection.
- Reduced liver function judged with bilirubin, INR and transaminases
- Anticoagulation with warfarin
- Ongoing use of NSAIDs or 5-HT3 antagonists, or use of such drugs last week
- Ongoing palliative radiation treatment or radiation treatment during the last 4 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Medication for Cancer Pain. The Effect of Paracetamol. A Clinical and Pharmacological Trial to Research Whether Paracetamol Gives an Additional Effect on Pain Relief When the Patient is Treated With High Doses of Opioids
Randomised, double-blind placebo controlled cross-over trial
Main goal:
Optimize the medical pain treatment for patients with advanced cancer disease
Study goal:
Measure paracetamol's additional analgesic effect in a situation where the patient is concomitantly treated with oral opioids eqv. morphine > 100 mg/d.
Read the detailed description
National multicenter study with an intention to include 50 patients. 6 days treatment, 3d in each arm. Mean pain score last 24 h: NRS =/> 4 All drug treatment constant during the study period. The participants are allowed to take as much rescue opioids as necessary to have adequate relief.
Paracetamol/ placebo given orally 1000 mg x 4 daily, three days in each arm, direct crossover.
Daily scoring of pain relief, ESAS, overall satisfaction and rescue medication.
- Conditions
- Advanced Cancer, Opioid Use, Unspecified
- Being tested
- paracetamol, placebo tablets
- Keywords
- Paracetamol, opioids, cancer pain
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamolDrug
Also called Acetaminophen
1000 mg 4 times daily
placebo tabletsDrug
Also called Suger pills
Placebo pills eqv paracetamol are given 2 tablets 4 times daily instead of paracetamol
| Study group | Role | What they receive |
|---|---|---|
| Placebo pills | Placebo comparator | Placebo tablets resembling paracetamol 500 mg are given as alternative 2 tablets 4 times daily Receives: Drug: placebo tablets |
| oral paracetamol 4 g daily | Active comparator | Patients are given 2 tablets of 500 mg paracetamol on a regular basis 4 times daily Receives: Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction caused by paracetamol 4g/d
Pain reduction in the active paracetamol arm, compared to placebo, corrected for difference in rescue medication intake.
Measured: Last day in each 3 days study period
Secondary outcomes (1)
Overall satisfaction with the pain treatment
Total ESAS score Sweating during nighttime general wellbeing
Measured: End of each 3 days study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haraldsplass Deaconess Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jan Henrik Rosland, MD, PhD, Principal investigator, Haraldsplass Deaconess Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313247
- Sponsor's protocol ID
- Par 06-0045
- Status last verified
- Mar 2011
- First submitted
- 10 Mar 2011
- Last updated
- 11 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Medication for Cancer Pain. The Effect of Paracetamol. A Clinical and Pharmacological Trial to Research Whether Paracetamol Gives an Additional Effect on Pain Relief When the Patient is Treated With High Doses of Opioids
- ClinicalTrials.gov ID
- NCT01313247
- Acronym / sponsor ID
- Par 06-0045
- Conditions
- Advanced Cancer, Opioid Use, Unspecified
- Keywords
- Paracetamol, opioids, cancer pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Haraldsplass Deaconess HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 11 Mar 2011 (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.
Randomised, double-blind placebo controlled cross-over trial
Main goal:
Optimize the medical pain treatment for patients with advanced cancer disease
Study goal:
Measure paracetamol's additional analgesic effect in a situation where the patient is concomitantly treated with oral opioids eqv. morphine > 100 mg/d.
Detailed description
National multicenter study with an intention to include 50 patients. 6 days treatment, 3d in each arm. Mean pain score last 24 h: NRS =/> 4 All drug treatment constant during the study period. The participants are allowed to take as much rescue opioids as necessary to have adequate relief.
Paracetamol/ placebo given orally 1000 mg x 4 daily, three days in each arm, direct crossover.
Daily scoring of pain relief, ESAS, overall satisfaction and rescue medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo pills | Placebo comparator | Drug: placebo tabletsPlacebo tablets resembling paracetamol 500 mg are given as alternative 2 tablets 4 times daily |
| oral paracetamol 4 g daily | Active comparator | Drug: paracetamolPatients are given 2 tablets of 500 mg paracetamol on a regular basis 4 times daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (> 18 years) of both sexes
- Diagnosed with advanced cancer disease
- Ongoing medicinal pain relief treatment in stable dosing with oral opiates equivalent to > 100 mg oral morphine daily
- NRS median pain score last 24 hrs > 4
- Able to take tablets (paracetamol) orally
Key exclusion criteria (5 listed)
- Mental or physical deficiency precluding data collection.
- Reduced liver function judged with bilirubin, INR and transaminases
- Anticoagulation with warfarin
- Ongoing use of NSAIDs or 5-HT3 antagonists, or use of such drugs last week
- Ongoing palliative radiation treatment or radiation treatment during the last 4 weeks.
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 |
|---|---|---|
| paracetamolAlso: Acetaminophen1000 mg 4 times daily | Drug | oral paracetamol 4 g daily |
| placebo tabletsAlso: Suger pillsPlacebo pills eqv paracetamol are given 2 tablets 4 times daily instead of paracetamol | Drug | Placebo pills |
Primary outcome
Pain reduction caused by paracetamol 4g/d
Time frame: Last day in each 3 days study period
Pain reduction in the active paracetamol arm, compared to placebo, corrected for difference in rescue medication intake.
1 secondary outcome
Overall satisfaction with the pain treatment
Time frame: End of each 3 days study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2011.
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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.
Jan Henrik Rosland, MD, PhD principal investigator
Haraldsplass Deaconess Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing paracetamol in people with Advanced Cancer and Opioid Use, Unspecified, run by Haraldsplass Deaconess Hospital at 1 site in Norway.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Mar 2011. 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 Norway. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Henrik Rosland, MD, PhD (+4755979400 ext. 79387, jhro@haraldsplass.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction caused by paracetamol 4g/d (time frame: Last day in each 3 days study period). 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 11 Mar 2011.