Pain, ChronicPARADISENCT04523740
Paracetamol Discontinuation in the Elderly After Long-term Consumption
A study testing Paracetamol in people with Pain, Chronic and Pain, Medication, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial summary
To investigate if long-term treatment of paracetamol can be discontinued without no worsening on pain, health-related quality-of-life and level of function compared to continuing paracetamol treatment in patients aged 65 years or more. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pain, Chronic, Pain, Medication, Pain, Discontinuation
- 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
- 98 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2020to Dec 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years or more
- Regular daily users of 3 to 4 grams of paracetamol for at least 6 months prior to enrollment
Who cannot join
- Malignant pain cf. their medical records
- Patients using other regular analgesics cf. indication on prescription
- Patients receiving paracetamol tablets with modified release or sustained release
- Patients in warfarin treatment
- Patients with terminal illnesses, cf. their medical records.
- Patients receiving dosages dispensed by their pharmacy
- Mini-Mental State Examination (MMSE) score less than 25
- Patients with or suspected to have COVID-19.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of clinical pharmacology
Copenhagen, Bispebjerg, 2400
About this study
To investigate if long-term treatment of paracetamol can be discontinued without no worsening on pain, health-related quality-of-life and level of function compared to continuing paracetamol treatment in patients aged 65 years or more.
Read the detailed description
Aim: To investigate if long-term treatment of paracetamol can be discontinued without worsening on pain, health-related quality-of-life and level of function compared to continuing paracetamol treatment in patients aged 65 years or more.
Trial design: Patients are randomized to either arm 1: standard care (paracetamol continuation) or arm 2: experimental treatment (placebo).
The investigation is double-blinded.
Patients are screened and recruited from Department of respiratory medicine at Copenhagen University Hospital Bispebjerg. Patients with a daily consumption of 3 grams or more of prescribed paracetamol and who comply with the other eligibility criteria will be invited to participate in the trial and asked for written, informed consent. If given we collect data regarding the patient's medications, any medication changes during the intervention and followup, frailty (FRAIL Scale), self-reported history of falls, recent admissions, self-reported health-related quality of life (EQ-5D-5L), level of function tested by hand grib strength and sitting-rising test, and death.
Data is collected at baseline and after 2 weeks when ending treatment intervention, and a 26 week follow-up.
- Conditions
- Pain, Chronic, Pain, Medication, Pain, Discontinuation
- Being tested
- Placebo, Paracetamol
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Patients who use regular paracetamol will now receive 6 to 8 tablets of placebo per day for 2 weeks
ParacetamolDrug
Also called Acetaminophen
Patients who use regular paracetamol will now receive 6 to 8 tablets of 500 mg paracetamol per day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo replacement | Experimental | Participants will discontinue the paracetamol treatment, and be administered 6 to 8 tablets of placebo per day Receives: Drug: Placebo |
| Usual care with paracetamol | Active comparator | Participants will continue the paracetamol treatment, and be administered 6 to 8 tablets of 500mg paracetamol per day Receives: Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) pain during til last 24 hours
Comparison of changes in visual analog scale (VAS) pain intensity during the last 24 hours, from baseline value at week 2 between the control and intervention group. VAS is a 0-100 mm scale where 0 is "no pain" and 100 is "worst pain"
Measured: Change from baseline value at week 2
Secondary outcomes (9)
EQ5D-5L index
Comparison of changes in EQ5D-5L index from baseline values at week 2 between the control and intervention group. EQ-5D is an abbreviation for "European Quality of life - 5 Dimensions" and measures Quality of Life. The scale has five subcomponents with scores from 1 (best) to 5 (worst). The five subcomponents constitute a health state that is translated into an index value using the Danish Crosswalk Index Value Calculator from Euroqol's website. The index value is anchored at 0 = death and 1 = full health and the range in the Danish population is from -0.624 (worse than death) to 1.0 (full health). Higher values / increases in index value is better than lower values / decreases in index value.
Measured: Change from baseline value at week 2
Treatment failure.
Number of participants that initiate other regular analgesics or withdraw from the trial
Measured: Week 2
Grip strength
Functional level is measured by grib strength with a Hand Dynamometer
Measured: Change from baseline value at week 2
Sitting-rising test
Functional level is measured by a sitting-rising test
Measured: Change from baseline value at week 2
Sum of daily visual analog scale (VAS) pain
Collected from a trial diary. Visual analog scale (VAS) is a 0-100 mm scale where 0 is "no pain" and 100 is "worst pain"
Measured: Sum from baseline to week 2
Followup: Number of regular users (3 grams of paracetamol or more per day) since ending treatment period.
Did the intervention change the participants' paracetamol consumption after ending the treatment period.
Measured: week 26
Followup: Visual analog scale (VAS) pain during til last 24 hours
Comparison of changes from baseline and week 2 values at week 26 (post treatment period). Visual analog scale (VAS) is a 0-100 mm scale where 0 is "no pain" and 100 is "worst pain"
Measured: Week 26
Followup: EQ5D-5L index
Comparison of changes in EQ5D-5L index from baseline and week 2 values at week 26 (post treatment period) between the control and intervention group. EQ-5D is an abbreviation for "European Quality of life - 5 Dimensions" and measures Quality of Life. The scale has five subcomponents with scores from 1 (best) to 5 (worst). The five subcomponents constitute a health state that is translated into an index value using the Danish Crosswalk Index Value Calculator from Euroqol's website. The index value is anchored at 0 = death and 1 = full health and the range in the Danish population is from -0.624 (worse than death) to 1.0 (full health). Higher values / increases in index value is better than lower values / decreases in index value.
Measured: Week 26
Trial failure
Number of participants who initiated regular use of other analgesics and comparison of changes between the control and intervention group (post treatment period)
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study startAug 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lykke Ida Kaas Oldenburg, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Jon T Andersen, MD, PhD, Principal investigator, Department of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523740
- Sponsor's protocol ID
- 2019-000203-33
- Other IDs
- 2019
- Acronym
- PARADISE
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracetamol Discontinuation in the Elderly After Long-term Consumption
- ClinicalTrials.gov ID
- NCT04523740
- Acronym / sponsor ID
- PARADISE / 2019-000203-33
- Conditions
- Pain, Chronic, Pain, Medication, Pain, Discontinuation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 24 Aug 2020 (actual)
- 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.
To investigate if long-term treatment of paracetamol can be discontinued without no worsening on pain, health-related quality-of-life and level of function compared to continuing paracetamol treatment in patients aged 65 years or more.
Detailed description
Aim: To investigate if long-term treatment of paracetamol can be discontinued without worsening on pain, health-related quality-of-life and level of function compared to continuing paracetamol treatment in patients aged 65 years or more.
Trial design: Patients are randomized to either arm 1: standard care (paracetamol continuation) or arm 2: experimental treatment (placebo).
The investigation is double-blinded.
Patients are screened and recruited from Department of respiratory medicine at Copenhagen University Hospital Bispebjerg. Patients with a daily consumption of 3 grams or more of prescribed paracetamol and who comply with the other eligibility criteria will be invited to participate in the trial and asked for written, informed consent. If given we collect data regarding the patient's medications, any medication changes during the intervention and followup, frailty (FRAIL Scale), self-reported history of falls, recent admissions, self-reported health-related quality of life (EQ-5D-5L), level of function tested by hand grib strength and sitting-rising test, and death.
Data is collected at baseline and after 2 weeks when ending treatment intervention, and a 26 week follow-up.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo replacement | Experimental | Drug: PlaceboParticipants will discontinue the paracetamol treatment, and be administered 6 to 8 tablets of placebo per day |
| Usual care with paracetamol | Active comparator | Drug: ParacetamolParticipants will continue the paracetamol treatment, and be administered 6 to 8 tablets of 500mg paracetamol per day |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65 years or more
- Regular daily users of 3 to 4 grams of paracetamol for at least 6 months prior to enrollment
Key exclusion criteria (8 listed)
- Malignant pain cf. their medical records
- Patients using other regular analgesics cf. indication on prescription
- Patients receiving paracetamol tablets with modified release or sustained release
- Patients in warfarin treatment
- Patients with terminal illnesses, cf. their medical records.
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 |
|---|---|---|
| PlaceboPatients who use regular paracetamol will now receive 6 to 8 tablets of placebo per day for 2 weeks | Drug | Placebo replacement |
| ParacetamolAlso: AcetaminophenPatients who use regular paracetamol will now receive 6 to 8 tablets of 500 mg paracetamol per day for 2 weeks | Drug | Usual care with paracetamol |
Primary outcome
Visual analog scale (VAS) pain during til last 24 hours
Time frame: Change from baseline value at week 2
Comparison of changes in visual analog scale (VAS) pain intensity during the last 24 hours, from baseline value at week 2 between the control and intervention group. VAS is a 0-100 mm scale where 0 is "no pain" and 100 is "worst pain"
9 secondary outcomes
EQ5D-5L index
Time frame: Change from baseline value at week 2
Treatment failure.
Time frame: Week 2
Grip strength
Time frame: Change from baseline value at week 2
Sitting-rising test
Time frame: Change from baseline value at week 2
Sum of daily visual analog scale (VAS) pain
Time frame: Sum from baseline to week 2
Followup: Number of regular users (3 grams of paracetamol or more per day) since ending treatment period.
Time frame: week 26
Followup: Visual analog scale (VAS) pain during til last 24 hours
Time frame: Week 26
Followup: EQ5D-5L index
Time frame: Week 26
Trial failure
Time frame: Week 26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Jon T Andersen, MD, PhD principal investigator
Department of Clinical Pharmacology
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, Chronic and Pain, Medication, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
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 2 inclusion and 8 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 25 Aug 2020. 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 Denmark. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Vermehren, PhD (+45 3863 5209, Charlotte.Vermehren@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) pain during til last 24 hours (time frame: Change from baseline value at week 2). 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 25 Aug 2020.