Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PARASTOP - Paracetamol With Strong Opioids (PARASTOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05051735
Recruitment Status : Recruiting
First Posted : September 21, 2021
Last Update Posted : October 22, 2021
Sponsor:
Collaborator:
Sykehuset Telemark
Information provided by (Responsible Party):
Ørnulf Paulsen, Oslo University Hospital

Brief Summary:

Current guidelines recommend all people with cancer-related pain should be prescribed paracetamol, even those receiving high doses of strong pain killers (opioids) such as morphine. Although this has been shown in studies to be beneficial in other conditions, for instance dental work and after surgery, it has not been shown to further improve pain in people with cancer-related pain. Taking tablets is burdensome to patients and the study aims to determine whether the inconvenience of taking eight extra paracetamol tablets per day can be justified.

The study plans to show whether or not pain control is changed (non-inferior) when stopping paracetamol compared to continued use of paracetamol in people already taking strong pain killers for cancer-related pain. Voluntary participants who are taking a combination of paracetamol and a strong opioid are recruited to the study.


Condition or disease Intervention/treatment Phase
Cancer Pain Cancer Drug: Paracetamol Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PARASTOP - Paracetamol With Strong Opioids. A Randomized, Double-blind, Parallel-group Non-inferiority Phase III Withdrawal Trial of Paracetamol Versus Placebo in Conjunction With Opioids for Moderate to Severe Cancer-related Pain
Actual Study Start Date : October 20, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Paracetamol
Paracetamol P.O. 500 mg 2 tablets four times a day for 7 days
Drug: Paracetamol
Paracetamol 500 mg
Other Name: Acetaminophen

Placebo Comparator: Placebo
Placebo P.O. 2 tablets four times a day for 7 days
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. To establish whether placebo with strong opioids compared to paracetamol together with strong opioids provides non-inferior analgesia for cancer-related pain. [ Time Frame: 7 days ]
    Numeric Rating Scale 0-10: Average pain intensity past 24 hours


Secondary Outcome Measures :
  1. To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes opioid related side effects. [ Time Frame: 7 days ]
    Opioid Side Effects Questionnaire

  2. To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes global rating of improvement. [ Time Frame: 7 days ]
    Patient Global Impression of Change

  3. To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes opioid requirements. [ Time Frame: 7 days ]
    Opioid consumption



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must be ≥ 18 years of age inclusive, at the time of signing the informed consent.
  • ≥50 kg (due to paracetamol dosage)
  • Participants who are under palliative care or oncology service review
  • Diagnosis of metastatic cancer
  • Clinician-predicted life expectancy >2 months
  • Receiving daily regular strong opioids for cancer pain
  • Receiving stable scheduled opioid dose last 48 hours*
  • Receiving paracetamol 1 gram x three or four times a day for at least five days
  • Average pain intensity past 24 hours ≥ 2 and ≤ 7 (NRS 0-10)*
  • Able to take study drug/placebo as tablets
  • Able to comply with all study procedures
  • Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

    • It is allowed to repeat procedure within the screening period without considering the participant being a rescreen

Exclusion Criteria:

  • History of allergy or hypersensitivity to any of the active substances or excipients in the study drug
  • Known severe liver or renal failure equivalent with CTCAE Grade 3 or 4* precluding continuation of paracetamol. (*Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0)
  • Participants receiving subcutaneous, intravenous, intrathecal, or epidural opioid therapy
  • Participants receiving systemic anticancer treatment during the intervention period if they are anticipated to have increasing pain or other symptoms related to the treatment
  • Co-enrolment in other drug trials. Participants will not be enrolled in any other on-going interventional clinical trial. Study participants may be enrolled in non-interventional research (e.g. questionnaire, tissue collection studies)
  • Previously enrolled in this study
  • Pregnant or lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05051735


Contacts
Layout table for location contacts
Contact: Lise Torpen +4790864581 linyto@ous-hf.no

Locations
Layout table for location information
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Not yet recruiting
Milano, Italy
Contact: Augusto Caraceni         
Principal Investigator: Augusto Caraceni         
Sub-Investigator: Alessandra Pigni         
Norway
Akershus University Hospital Not yet recruiting
Lørenskog, Norway, 1478
Contact: Olav Fredheim         
Principal Investigator: Olav Fredheim         
OsloUH Not yet recruiting
Oslo, Norway, 0424
Contact: Lise Torpen         
Principal Investigator: Katarina Rønning Hagen         
Telemark Hospital Trust Recruiting
Skien, Norway
Contact: Ørnulf Paulsen         
Principal Investigator: Ørnulf Paulsen         
Universitetssykehuset Nord-Norge Not yet recruiting
Tromsø, Norway, 9019
Contact: Sigve Andersen         
Principal Investigator: Sigve Andersen         
St. Olavs Hospital Not yet recruiting
Trondheim, Norway, 7030
Contact: Erik Torbjørn Løhre         
Principal Investigator: Erik Torbjørn Løhre         
Vestfold Hospital trust Not yet recruiting
Tønsberg, Norway, 3103
Contact: Arve Nordbø         
Principal Investigator: Arve Nordbø         
Helse Møre og Romsdal Not yet recruiting
Ålesund, Norway, 6026
Contact: Jo Åsmund Lund         
Principal Investigator: Jo Åsmund Lund         
United Kingdom
Edinburgh Cancer Research Not yet recruiting
Edinburgh, United Kingdom
Contact: Marie Fallon         
Principal Investigator: Marie Fallon         
Sponsors and Collaborators
Oslo University Hospital
Sykehuset Telemark
Investigators
Layout table for investigator information
Principal Investigator: Ørnulf Paulsen Telemark Hospital Trust
Layout table for additonal information
Responsible Party: Ørnulf Paulsen, Senior Consultant, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT05051735    
Other Study ID Numbers: 180946
First Posted: September 21, 2021    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ørnulf Paulsen, Oslo University Hospital:
Cancer Pain
Pain
Analgesics
Sensory System Agents
Physiological Effects of Drugs
Additional relevant MeSH terms:
Layout table for MeSH terms
Cancer Pain
Pain
Neurologic Manifestations
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics