Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-01-02 @ 2:40 AM
Study NCT ID:
NCT01084161
Status:
COMPLETED
Last Update Posted:
2011-12-02
First Post:
2010-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Efficacy, Safety and Tolerability of N1539
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 486}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'dispFirstSubmitDate': '2011-06-24', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-28', 'studyFirstSubmitDate': '2010-03-05', 'dispFirstSubmitQcDate': '2011-11-28', 'studyFirstSubmitQcDate': '2010-03-09', 'dispFirstPostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the analgesic efficacy, duration of effect and safety of single doses of IV N1539 as measured by the SPID (summary of pain intensity) and TOPAR (summary of the time-weighted pain relief scores) from 0-24 hours.', 'timeFrame': 'at 60 minutes post dose and at 24 hours', 'description': 'Additionally, to determine the efficacy seen within the first hour after study drug administration, as measured by the SPID 0-60 minutes post-dose.'}], 'secondaryOutcomes': [{'measure': 'To assess the safety and tolerability of IV N1539 by laboratory data, vital signs, wound site evaluation and Adverse Events', 'timeFrame': '5-7 days post initial dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hysterectomy']}, 'referencesModule': {'references': [{'pmid': '31094806', 'type': 'DERIVED', 'citation': 'Rechberger T, Mack RJ, McCallum SW, Du W, Freyer A. Analgesic Efficacy and Safety of Intravenous Meloxicam in Subjects With Moderate-to-Severe Pain After Open Abdominal Hysterectomy: A Phase 2 Randomized Clinical Trial. Anesth Analg. 2019 Jun;128(6):1309-1318. doi: 10.1213/ANE.0000000000003920.'}, {'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': 'To determine the analgesic efficacy, duration of effect, and safety of single doses of N1539 in subjects undergoing open abdominal hysterectomy'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* moderate to severe pain with VAS of \\>/= 45 mm\n* undergo open abdominal hysterectomy\n* ASA I or II\n* signed ICF\n* BMI \\>18.5 and \\< 31.5 kg/m\\^2\n\nExclusion Criteria:\n\n* suspected metastatic cervical or endometrial cancer\n* prior abdominal surgery with postoperative complications\n* active pancreatitis, obstruction of biliary tree or total bilirubin\\> 2.5 mg/dL\n* active GI bleeding, or peptic ulcer disease\n* unstable medical condition\n* HbA1c \\>9.5 or uncontrolled diabetes\n* SBP \\>150 mmHg or DBP \\> 95 mmHg\n* personal or familial contraindication to undergoing general anesthesia\n* Antihypertensive agents or diabetic regimen that is not stable (4 weeks prior to surgery)\n* taking CNS agents for pain\n* acetaminophen or NSAIDs not discontinued for at least 5 half-lives prior to planned surgery\n* currently taking an opioid or has taken an opioid chronically for pain in past 2 years\n* corticosteroid or systemic corticosteroids within 6 weeks of planned surgery\n* has a known bleeding disorder or taking agents affecting coagulation\n* history of intolerance or allergic reactions to NSAIDs, COX-2 inhibitors, aspirin and other salicylates\n* receiving lithium or a combination of furosemide with an ACE inhibitor or angiotensin receptor blocker\n* Known to have sleep apnea\n* History of hepatitis B or C\n* AST or ALT \\> 2 times the upper limit of normal\n* Known or suspected COPD with retention of carbon dioxide\n* psychiatric condition that impairs the capability of the subject to report pain'}, 'identificationModule': {'nctId': 'NCT01084161', 'briefTitle': 'Study to Evaluate the Efficacy, Safety and Tolerability of N1539', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Randomized Double-Blind, Placebo- and Active-Controlled, Dose-Ranging Study to Evaluate the Analgesic, Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Open Abdominal Hysterectomy', 'orgStudyIdInfo': {'id': 'N1539-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'N1539 5 mg', 'interventionNames': ['Drug: N1539']}, {'type': 'EXPERIMENTAL', 'label': 'N1539 7.5 mg', 'interventionNames': ['Drug: N1539']}, {'type': 'EXPERIMENTAL', 'label': 'N1539 15 mg', 'interventionNames': ['Drug: N1539']}, {'type': 'EXPERIMENTAL', 'label': 'N1539 30 mg', 'interventionNames': ['Drug: N1539']}, {'type': 'EXPERIMENTAL', 'label': 'N1539 60 mg', 'interventionNames': ['Drug: N1539']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'morphine', 'interventionNames': ['Drug: Morphine']}], 'interventions': [{'name': 'N1539', 'type': 'DRUG', 'description': '5 mg IV once per day', 'armGroupLabels': ['N1539 5 mg']}, {'name': 'N1539', 'type': 'DRUG', 'description': '7.5 mg IV once per day', 'armGroupLabels': ['N1539 7.5 mg']}, {'name': 'N1539', 'type': 'DRUG', 'description': '15 mg IV once per day', 'armGroupLabels': ['N1539 15 mg']}, {'name': 'N1539', 'type': 'DRUG', 'description': '30 mg IV once per day', 'armGroupLabels': ['N1539 30 mg']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'IV placebo once per day', 'armGroupLabels': ['Placebo']}, {'name': 'Morphine', 'type': 'DRUG', 'description': 'morphine 10-15 mg IV once per day', 'armGroupLabels': ['morphine']}, {'name': 'N1539', 'type': 'DRUG', 'description': '60 mg IV once per day', 'armGroupLabels': ['N1539 60 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0159', 'city': 'Tbilisi', 'country': 'Georgia', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0186', 'city': 'Tbilisi', 'country': 'Georgia', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '15-276', 'city': 'Bialystok', 'country': 'Poland', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '80-402', 'city': 'Gdansk', 'country': 'Poland', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '94-029', 'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20-081', 'city': 'Lublin', 'country': 'Poland', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '60-535', 'city': 'Poznan', 'country': 'Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '41-703', 'city': 'Ruda Śląska', 'country': 'Poland', 'geoPoint': {'lat': 50.2584, 'lon': 18.85632}}, {'zip': '70-111', 'city': 'Szczecin', 'country': 'Poland', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '34000', 'city': 'Kragujevac', 'country': 'Serbia', 'geoPoint': {'lat': 44.01667, 'lon': 20.91667}}, {'zip': '21000', 'city': 'Novi Sad', 'country': 'Serbia', 'geoPoint': {'lat': 45.25167, 'lon': 19.83694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkermes, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}