Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT01015235
Status:
COMPLETED
Last Update Posted:
2011-09-02
First Post:
2009-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative 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': 'C584124', 'term': 'KAI-1678'}, {'id': 'D000095485', 'term': 'Bulk Drugs'}, {'id': 'D020911', 'term': 'Ketorolac Tromethamine'}, {'id': 'D020910', 'term': 'Ketorolac'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-31', 'studyFirstSubmitDate': '2009-11-16', 'studyFirstSubmitQcDate': '2009-11-17', 'lastUpdatePostDateStruct': {'date': '2011-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4).', 'timeFrame': 'Post operative Day 1'}], 'secondaryOutcomes': [{'measure': 'The effect of KAI-1678 on total pain relief over 4 hours (TOTPAR 4)', 'timeFrame': 'Post operative Day 1'}, {'measure': 'The effect of KAI-1678 on pain intensity difference (PID) at 4 hours', 'timeFrame': 'Post-operative Day 1'}, {'measure': 'The effect of KAI-1678 on total quality analgesia', 'timeFrame': 'Post-operative Day 1'}, {'measure': 'The effect of KAI-1678 on time to meaningful pain relief', 'timeFrame': 'Post-operative Day 1'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ketorolac / therapeutic use', 'Analgesics. Non-narcotic / therapeutic use', 'Arthroplasty, replacement hip', 'Arthroplasty, replacement knee', 'Pain measurement / drug effect', 'Pain postoperative / drug therapy'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postoperative pain following total hip or total knee replacement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologist (ASA) classification 1, 2, or 3\n* total hip or total knee replacement\n* pain on postoperative Day 1 at least 40 mm on 0-100 mm visual analog scale (VAS)\n\nExclusion Criteria:\n\n* presence of contraindications to nonsteroidal anti-inflammatory (NSAID) treatment\n* recent history of angina or myocardial infarction (MI)\n* clinically significant abnormality on laboratory tests or electrocardiogram (ECG)'}, 'identificationModule': {'nctId': 'NCT01015235', 'briefTitle': 'Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'KAI Pharmaceuticals'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo- and Active-Comparator-Controlled, Single-Dose Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion for the Treatment of Postoperative Pain', 'orgStudyIdInfo': {'id': 'KAI-1678-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 1: Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A2: KAI-1678', 'description': 'Test Drug', 'interventionNames': ['Drug: KAI-1678']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A3: Ketorolac', 'description': 'Active Comparator', 'interventionNames': ['Drug: Ketorolac Tromethamine']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Subcutaneous infusion-once over 4 hours', 'armGroupLabels': ['Arm 1: Placebo']}, {'name': 'KAI-1678', 'type': 'DRUG', 'otherNames': ['Active drug'], 'description': 'Subcutaneous infusion-once over 4 hours', 'armGroupLabels': ['A2: KAI-1678']}, {'name': 'Ketorolac Tromethamine', 'type': 'DRUG', 'otherNames': ['Ketorolac'], 'description': 'Active comparator, IV infusion, once', 'armGroupLabels': ['A3: Ketorolac']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamilton', 'country': 'New Zealand', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}], 'overallOfficials': [{'name': 'Gregory Bell, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'KAI Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KAI Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Trident Clinical Research Pty Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}