Nctid:
NCT06235320
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000000082", "term"=>"Acetaminophen"}, {"id"=>"D000007052", "term"=>"Ibuprofen"}], "ancestors"=>[{"id"=>"D000000894", "term"=>"Anti-Inflammatory Agents, Non-Steroidal"}, {"id"=>"D000018712", "term"=>"Analgesics, Non-Narcotic"}, {"id"=>"D000000700", "term"=>"Analgesics"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000000893", "term"=>"Anti-Inflammatory Agents"}, {"id"=>"D000018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D000016861", "term"=>"Cyclooxygenase Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000058633", "term"=>"Antipyretics"}], "browseLeaves"=>[{"id"=>"M10102", "name"=>"Ibuprofen", "asFound"=>"Autologous", "relevance"=>"HIGH"}, {"id"=>"M2340", "name"=>"Acetaminophen", "asFound"=>"Pill", "relevance"=>"HIGH"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}, {"id"=>"M4218", "name"=>"Anti-Inflammatory Agents, Non-Steroidal", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M20786", "name"=>"Analgesics, Non-Narcotic", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M19209", "name"=>"Cyclooxygenase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M29176", "name"=>"Antipyretics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antipyretics", "abbrev"=>"Antipy"}]}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITHOUT_DNA", "description"=>"blood and urine"}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>72}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-03-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-02", "completionDateStruct"=>{"date"=>"2026-03-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-02-07", "studyFirstSubmitDate"=>"2024-01-18", "studyFirstSubmitQcDate"=>"2024-01-30", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-08", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-09-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Prostanoid levels", "timeFrame"=>"just before treatment and 24 hours after treatment with paracetamol or ibuprofen", "description"=>"A comprehensive lipidomic analysis measuring the levels of prostanoids in plasma and spot urine samples using liquid chromatography tandem mass spectrometry (LC/ESI-MS/MS) technology in all participants."}], "secondaryOutcomes"=>[{"measure"=>"Blood pressure", "timeFrame"=>"just before treatment and 24 hours after treatment with paracetamol or ibuprofen", "description"=>"Automated office and ambulatory blood pressure measurement"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Pain"]}, "descriptionModule"=>{"briefSummary"=>"This research program aims to investigate the influence of paracetamol on blood pressure and the cyclooxygenase (COX) - prostaglandine (PG) pathway in patients with pain. Through an observational pilot study, we will use advanced LC/ESI-MS/MS methodology to analyze the COX-OG pathway in plasma and urine. The study will assess the effects of paracetamol compared to ibuprofen, considering different types of pain. The primary focus is to understand the changes in blood pressure and the COX-PG pathway upon initiation or discontinuation of paracetamol, with safety analysis as a secondary consideration."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"The first cohort consists of patients of the headache consultation at Charité Campus Mitte, where data is collected both within and outside of clinical routine, whereby the medical care of the respective patients takes place in the usual routine.\n\nThe second cohort consists of patients attending oral surgery consultations at the Institute of Dentistry, Oral and Maxillofacial Surgery, for whom data is also collected both within and outside of clinical routine, whereby the medical care of the respective patients takes place in the usual routine.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Headache and orosurgical patients treated at the respective charite outpatient clinic.\n* Age 18 years or older\n* Able to consent\n* Patients with migraine type headache treated with paracetamol or ibuprofen within the last 12 hours or not treated with paracetamol or ibuprofen within the last 48 hours\n* Patients treated with with paracetamol or ibuprofen undergoing orosurgery for wisedome tooth extraction\n\nExclusion Criteria:\n\n* Pregnancy\n* Arterial hypertension\n* Use of beta blockers\n* Use of COX inhibitors other than paracetamol or ibuprofen, including low-dose acetylsalicylic acid\n* Stable prophylactic therapy of migraine for less than 3 weeks\n* Use of tryptans in the last two days (Frovatriptane in the last 6 days)\n* Oral surgery patients using paracetamol or ibuprofen in the last 24 hours\n* Known allergy to paracetamol or ibuprofen"}, "identificationModule"=>{"nctId"=>"NCT06235320", "acronym"=>"PIS-PaB", "briefTitle"=>"Paracetamol Effect on Prostaglandins and Blood Pressure", "organization"=>{"class"=>"OTHER", "fullName"=>"Charite University, Berlin, Germany"}, "officialTitle"=>"Paracetamol Impact Study: Prostaglandin Synthesis and Blood Pressure Effects (PIS-PaB)", "orgStudyIdInfo"=>{"id"=>"PIS-PaB"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Paracetamol group", "interventionNames"=>["Other: routine clinical treatment of pain with paracetamol or ibuprofen"]}, {"label"=>"Ibuprofen group", "interventionNames"=>["Other: routine clinical treatment of pain with paracetamol or ibuprofen"]}], "interventions"=>[{"name"=>"routine clinical treatment of pain with paracetamol or ibuprofen", "type"=>"OTHER", "description"=>"No intervention beside clinical routine management", "armGroupLabels"=>["Ibuprofen group", "Paracetamol group"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Engi Algharably, PhD", "role"=>"CONTACT", "email"=>"engi.algharably@charite.de", "phone"=>"030/ 450 525 221"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"No plan to share individual patient data"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Charite University, Berlin, Germany", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Dr.", "investigatorFullName"=>"Engi Algharably", "investigatorAffiliation"=>"Charite University, Berlin, Germany"}}}}
