Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT00508495
Status:
COMPLETED
Last Update Posted:
2011-08-11
First Post:
2007-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-10', 'studyFirstSubmitDate': '2007-07-26', 'studyFirstSubmitQcDate': '2007-07-26', 'lastUpdatePostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of PCA-administered morphine consumed during first six hours of study drug treatment', 'timeFrame': '6 hours from first (of four) study drug doses'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pain, postoperative', 'replacement, total hip', 'total hip replacement', 'arthroplasty, replacement, hip'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the therapeutic efficacy, safety and local tolerability of two different paracetamol-containing solutions in postoperative total hip replacement. They will be compared to placebo (a dummy treatment which contains no active ingredient).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I, II or III and scheduled for elective total hip replacement, using a standard approach and a cemented implant.\n* Moderate or severe pain within 4 hours after stopping the PCA in the morning of the first post-operative day.\n\nExclusion Criteria:\n\n* Another acute or chronic painful physical condition\n* Use of any other analgesics (within 24 hours), sedatives, or narcotic drugs as well as microsomal enzyme inducers\n* Inability to use and understand Visual Analog Scale and Verbal Rating Score'}, 'identificationModule': {'nctId': 'NCT00508495', 'briefTitle': 'Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Baxter Healthcare Corporation'}, 'officialTitle': 'Single-Dose Comparison of the Analgesic Efficacy, Safety and Tolerability of Two Paracetamol 1%-Containing Solutions and Placebo in a Post-Surgical Total Hip Replacement Model', 'orgStudyIdInfo': {'id': 'R-01270-A016'}, 'secondaryIdInfos': [{'id': 'EudraCT 2006-004075-36'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test drug', 'interventionNames': ['Drug: Paracetamol 1% solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference drug', 'interventionNames': ['Drug: Paracetamol (acetaminophen)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: 0.9% sodium chloride solution']}], 'interventions': [{'name': 'Paracetamol (acetaminophen)', 'type': 'DRUG', 'otherNames': ['Perfalgan'], 'description': 'Four 100 mL, 15 min IV infusions at six hour intervals', 'armGroupLabels': ['Reference drug']}, {'name': 'Paracetamol 1% solution', 'type': 'DRUG', 'description': 'Four 100 mL, 15 min IV infusions at six hour intervals', 'armGroupLabels': ['Test drug']}, {'name': '0.9% sodium chloride solution', 'type': 'DRUG', 'otherNames': ['Normal saline solution'], 'description': 'Four 100 mL, 15 min IV infusions at six hour intervals', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Békéscsaba', 'country': 'Hungary', 'facility': 'Réthy Pál Kórház-Rendelőintézet', 'geoPoint': {'lat': 46.68333, 'lon': 21.1}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis Egyetem Ortopédiai Klinika', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Esztergom', 'country': 'Hungary', 'facility': 'Esztergom Város Önkormányzat Vaszary Kolos Kórháza', 'geoPoint': {'lat': 47.7928, 'lon': 18.74148}}, {'city': 'Győr', 'country': 'Hungary', 'facility': 'Petz Aladár Megyei Oktató Kórház', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'city': 'Kecskemét', 'country': 'Hungary', 'facility': 'Bács-Kiskun Megyei Önkormányzat Kórháza', 'geoPoint': {'lat': 46.90618, 'lon': 19.69128}}, {'city': 'Szeged', 'country': 'Hungary', 'facility': 'SZTE ÁOK Ortopédiai Klinika', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'city': 'Szekszárd', 'country': 'Hungary', 'facility': 'Tolna Megyei Önkormányzat Balassa János Kórháza', 'geoPoint': {'lat': 46.34723, 'lon': 18.71189}}, {'city': 'Székesfehérvár', 'country': 'Hungary', 'facility': 'Fejér Megyei Szent György Kórház', 'geoPoint': {'lat': 47.18995, 'lon': 18.41034}}], 'overallOfficials': [{'name': 'Keyvan Tadjalli Mehr, MD, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Baxter Deutschland GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'MDS Pharma Services', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Keyvan Tadjalli Mehr, MD, MSc/Medical Director', 'oldOrganization': 'Baxter Deutschland GmbH'}}}}