Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT01436032
Status:
TERMINATED
Last Update Posted:
2012-03-14
First Post:
2011-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020911', 'term': 'Ketorolac Tromethamine'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'dispFirstSubmitDate': '2012-03-12', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-12', 'studyFirstSubmitDate': '2011-09-15', 'dispFirstSubmitQcDate': '2012-03-12', 'studyFirstSubmitQcDate': '2011-09-16', 'dispFirstPostDateStruct': {'date': '2012-03-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sum of the time-weighted pain intensity differences (SPID) as recorded on the Visual Analog Scale (VAS) from baseline (time 0) to 24 hours following the first dose of study medication (SPID 24)', 'timeFrame': '0 to 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Laparoscopic Surgery']}, 'referencesModule': {'references': [{'pmid': '30737315', 'type': 'DERIVED', 'citation': 'Viscusi ER, Gan TJ, Bergese S, Singla N, Mack RJ, McCallum SW, Du W, Hobson S. Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects. Reg Anesth Pain Med. 2019 Mar;44(3):360-368. doi: 10.1136/rapm-2018-100184. Epub 2019 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the analgesic efficacy and safety of N1539 in subjects undergoing abdominal laparoscopic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planning to undergo elective abdominal laparoscopic surgery involving a single site/organ and does not have intraperitoneal metastases suspected or identified\n\nExclusion Criteria:\n\n* Use of ketorolac is contraindicated\n* Use of general anesthesia is contraindicated\n* Has a medical condition that could adversely impact subject participation\n* Has diabetes mellitus and glycosylated hemoglobin (HbA1c) \\>9.5 or history of prolonged uncontrolled diabetes\n* Body mass index (BMI) less than 18 or greater than 35\n* Has a history of intolerance or allergic reactions to non-steroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors, aspirin or other salicylates\n* Known or suspected sleep apnea\n* History of Hepatitis B or C\n* Has a psychiatric disorder that impairs capability of subject to report pain\n* Known to have chronic obstructive pulmonary disease (COPD) with carbon dioxide retention or chronic hypoxemia'}, 'identificationModule': {'nctId': 'NCT01436032', 'briefTitle': 'Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Abdominal Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'N1539-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'N1539 15 mg', 'interventionNames': ['Drug: N1539']}, {'type': 'EXPERIMENTAL', 'label': 'N1539 30 mg', 'interventionNames': ['Drug: N1539']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketorolac', 'description': 'IV', 'interventionNames': ['Drug: Ketorolac Tromethamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'IV', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'N1539 7.5mg', 'interventionNames': ['Drug: N1539']}], 'interventions': [{'name': 'N1539', 'type': 'DRUG', 'description': 'IV', 'armGroupLabels': ['N1539 7.5mg']}, {'name': 'N1539', 'type': 'DRUG', 'description': 'IV', 'armGroupLabels': ['N1539 15 mg']}, {'name': 'N1539', 'type': 'DRUG', 'description': 'IV', 'armGroupLabels': ['N1539 30 mg']}, {'name': 'Ketorolac Tromethamine', 'type': 'DRUG', 'description': 'IV', 'armGroupLabels': ['Ketorolac']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'IV', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Lotus Clinical Research LLC', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}], 'overallOfficials': [{'name': 'Neil Singla, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lotus Clinical Research, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkermes, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}