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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05088876
Other study ID # BASEC-ID: 2021-01518
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 30, 2024
Est. completion date December 1, 2024

Study information

Verified date June 2024
Source Insel Gruppe AG, University Hospital Bern
Contact Evangelia Liakoni
Phone 0041316325461
Email evangelia.liakoni@insel.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Blinded withdrawal of regular co-medication with paracetamol in chronic pain patients under strong opioids on pain control.


Description:

Chronic pain cancer patients receiving a strong opioid in combination with paracetamol in a minimum dose of 1.5 g/day will be randomized to receive either paracetamol in the dose already prescribed (group "paracetamol") or an identically looking placebo (group "placebo") using the same schedule during the first study phase (days 1-7). In the second study phase (days 8-14) paracetamol or placebo will be stopped in both arms to assess the effect of pill withdrawal on pain control. Next to baseline the patients will be instructed to use a pain diary to rate their pain during the study and also document the required opioid rescue doses. Further assessments will include adverse events, subjective ratings of quality of sleep, overall feeling of functioning and quality of life. At the screening visit, patients will also be asked to rate their expected changes in pain relief as a result of co-treatment with paracetamol. At the completion of the study, patients will be asked about their preference and whether, overall, they felt their pain was more poorly controlled during the study. Between the on-site visits, patients will be followed up by phone calls on day 3 (±1d) and day 10 (±1d). Adherence will be checked by pill count and measurement of paracetamol blood concentrations. Genotyping of OPRM1, COMT and relevant CYP enzymes and opioid blood concentrations will be assessed as co-variates for pain control.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date December 1, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male and female cancer patients receiving a WHO step III opioid (i.e. morphine, oxycodone, methadone, fentanyl, hydromorphone, or buprenorphine) in combination with paracetamol (minimum dose 1.5 g/day) - Age = 18 at screening - Ability to understand the study procedures and to provide written informed consent - Stable analgesia before randomisation, defined as no required changes in the analgesic treatment during the previous 7 days Exclusion Criteria: - Participation in another interventional trial within 30 days prior to randomisation, with the exception of cancer treatment trials - Changes of the dosage or start of other (co-)analgesics (e.g. tricyclic antidepressants, neuroleptics, nonsteroidal anti-inflammatory drugs (NSAIDs), dipyrone), within the last 7 days preceding randomisation - Surgery within the 14 days preceding randomisation or surgery planned within the duration of the study - Any circumstances, comorbidities or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the study protocol

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Blinded withdrawal of regular co-medication with paracetamol
Paracetamol
Paracetamol in the dose already used

Locations

Country Name City State
Switzerland Kantonsspital Baden Baden
Switzerland Inselspital, Bern University Hospital Bern

Sponsors (2)

Lead Sponsor Collaborator
Insel Gruppe AG, University Hospital Bern Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary VAS score (average pain intensity) Study day 7
Secondary Average pain using the Brief Pain Inventory (BPI) On each study day, up to 14 days
Secondary Minimum pain using the Brief Pain Inventory (BPI) On each study day, up to 14 days
Secondary Worst pain using the Brief Pain Inventory (BPI) On each study day, up to 14 days
Secondary Current pain using the Brief Pain Inventory (BPI) On each study day, up to 14 days
Secondary Average pain using the Brief Pain Inventory (BPI) During the last four days of each study phase (days 4-7 und 11-14)
Secondary Minimum pain using the Brief Pain Inventory (BPI) During the last four days of each study phase(days 4-7 und 11-14)
Secondary Worst pain using the Brief Pain Inventory (BPI) During the last four days of each study phase (days 4-7 und 11-14)
Secondary Current pain using the Brief Pain Inventory (BPI) During the last four days of each study phase (days 4-7 und 11-14)
Secondary Cumulative dose of rescue medication used On each study day, up to 14 days
Secondary Cumulative dose of rescue medication used During the last four days of each study phase (days 4-7 und 11-14)
Secondary Number of rescue medication used On each study day, up to 14 days
Secondary Number of rescue medication used During the last four days of each study phase (days 4-7 und 11-14)
Secondary Percentage increase in pain compared to baseline During each study phase (days 1-7 and days 8-14)
Secondary Percentage of patients meeting the predefined pain threshold During each study phase (days 1-7 and days 8-14)
Secondary Subjective ratings of quality of sleep using the Brief Pain Inventory (BPI) At baseline and during each study phase (days 1-7 and days 8-14)
Secondary Subjective ratings of quality of life using the EQ-5D-5L questionnaire At baseline and during each study phase (days 1-7 and days 8-14)
Secondary Subjective ratings of functioning using the Brief Pain Inventory (BPI) and the EQ-5D-5L questionnaire At baseline and during each study phase (days 1-7 and days 8-14)
Secondary Patients' expectation regarding pain relief from paracetamol prior to study treatment paracetamol using the Expectation for Treatment Scale (ETS) Five-item ETS with each item rated on a 4-point scale ranging from 1 to 4 (partially disagree, partially agree, agree and definitely agree) Prior to study treatment
Secondary Question about participant's preference Study vs. baseline At day 7 and 14
Secondary Participant's impression of change 11-point scale tool between -5 ="very much worse" and +5 ="completely recovered" At day 7 and 14
Secondary Participants' guess regarding their assigned group (verum or placebo) At day 7 and 14
Secondary Assessment of serious adverse events During each study phase (days 1-7 and days 8-14)
Secondary Assessment of specific adverse events: nausea/vomiting During each study phase (days 1-7 and days 8-14)
Secondary Assessment of specific adverse events: drowsiness During whole study (days 1-14)
Secondary Assessment of specific adverse events: appetite During each study phase (days 1-7 and days 8-14)
Secondary Assessment of specific adverse events: constipation During each study phase (days 1-7 and days 8-14)
Secondary Assessment of other adverse events During each study phase (days 1-7 and days 8-14)
Secondary Number of withdrawals from study or treatment During each study phase (days 1-7 and days 8-14)
Secondary Time (days) of stable pain control During whole study (days 1-14)
Secondary Patients' potential to develop hepatotoxicity (investigation of risk factors) During whole study (days 1-14)
Secondary % hours with pain/24h On each study day, up to 14 days
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