Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-05 @ 11:32 AM
Study NCT ID:
NCT02706769
Status:
TERMINATED
Last Update Posted:
2019-09-27
First Post:
2016-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'whyStopped': 'Funding was terminated early due to slow recruitment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-25', 'studyFirstSubmitDate': '2016-01-25', 'studyFirstSubmitQcDate': '2016-03-07', 'lastUpdatePostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 16 years and over\n2. Under palliative care/oncology service review\n3. Diagnosis of incurable cancer\n4. Clinician-predicted life expectancy \\>2 months\n5. Anticipated to be clinically stable for duration of study involvement\n6. Receiving daily regular strong opioids\n7. Able to take study drug/placebo in its current form\n8. Prescribed and taking paracetamol 1g four times a day\n9. Average pain \\>3 and \\<9 in past 24 hours\n10. Able to provide written informed consent\n11. Able to complete necessary assessments required as part of the trial\n12. Average NRS pain score stable (ie. maximum range of 1 point) for the three consecutive days prior to randomisation\n\nExclusion Criteria:\n\n1. Pain which the clinician deems to be unstable\n2. Clinically significant renal or liver disease\n3. Weight less than 50kg\n4. Those whose pain is expected to change during the course of the study as a result of oncological or other treatments\n5. Co-enrolment in other drug trials\n6. Known to be pregnant or breast-feeding at the time of recruitment\n7. Previously enrolled in this study'}, 'identificationModule': {'nctId': 'NCT02706769', 'acronym': 'PaSO', 'briefTitle': 'Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'A Double-blind Randomised Parallel Group Trial of Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Related Pain', 'orgStudyIdInfo': {'id': 'AC15006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Paracetamol', 'description': 'Participants will take blinded Paracetamol (as they were taking before entering the study)', 'interventionNames': ['Drug: Paracetamol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will take blinded Paracetamol', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Study medication contains blinded placebo', 'armGroupLabels': ['Placebo']}, {'name': 'Paracetamol', 'type': 'DRUG', 'description': 'Study medication contains blinded paracetamol', 'armGroupLabels': ['Paracetamol']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH4 2XR', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Lothian', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}