Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-02-22 @ 4:13 PM
Study NCT ID:
NCT02381132
Status:
TERMINATED
Last Update Posted:
2016-03-25
First Post:
2015-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Open Label, Prospective Study to Explore the Clinical Characteristics of Oral MNK155 and Norco 7.5mg/325 When Used for the Treatment of Moderate to Severe Post Operative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-08-31', 'releaseDate': '2020-08-14'}, {'resetDate': '2021-03-31', 'releaseDate': '2021-03-05'}], 'estimatedResultsFirstSubmitDate': '2020-08-14'}}, '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': 'C514822', 'term': 'oxycodone-acetaminophen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-23', 'studyFirstSubmitDate': '2015-01-20', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative Pain Control', 'timeFrame': '48 hours', 'description': 'Patient Global Assessment'}], 'secondaryOutcomes': [{'measure': 'Post-operative Pain Control', 'timeFrame': '120 hours', 'description': 'Patient Global Assessment'}, {'measure': 'Post-operative Pain Control as Assessed by the Healthcare Professional', 'timeFrame': '48 and 120 hours', 'description': 'Healthcare Professional Global Assessments'}, {'measure': 'Subject Satisfaction Regarding Ease of Use and Pill Burden', 'timeFrame': '48 hours and 120 hours after treatment initation', 'description': 'Patient Satisfaction/Ease of Use and Pill Burden Assessment'}, {'measure': 'Subject Reported Worst Pain (Secondary to Analgesic Gaps)', 'timeFrame': '24 hours after treatment initiation', 'description': 'Assessment of Worst Pain- Numerical Rating Scale (NRS)'}, {'measure': 'Total Daily Acetaminophen Exposure', 'timeFrame': '24 hours, 48 hours, 72 hours, 96 hours and 120 hours after treatment initation', 'description': 'Number of Dosed of Acetaminophen'}, {'measure': 'Sleep Disturbance', 'timeFrame': '24 hours, 48 hours and 72 hours after treatment initiation', 'description': 'Assessment of Sleep Disturbance/Pain Interference with Sleep'}, {'measure': 'Opioid Related Symptoms', 'timeFrame': '48 hours after treatment initiation', 'description': 'Opioid Related Symptom Distress Scale (ORSDS)'}, {'measure': 'Pill Diversion', 'timeFrame': 'Day 5', 'description': 'Number of Pills Remaining and Accountability'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the clinical characteristics oral MNK155 and Norco® 7.5mg/325mg when used for the treatment of moderate to severe post operative pain.', 'detailedDescription': 'This is a single center, open label, prospective, randomized study on adult post operative subjects who are expected to require oral opioid analgesia for at least 48 hours after surgery. The main study drug of interest in this study is MNK 155. Norco® 7.5mg/325mg is being utilized only as active comparator.\n\nSubjects will be at least 18 years of age and will be scheduled to undergo elective surgery. The following surgical types will be allowed, although the list is not all inclusive:\n\n* Abdominal surgery\n* Soft tissue surgery\n* Orthopedic surgery\n* Spine surgery\n* Genitourinary surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects who provide written informed consent prior to enrollment.\n2. Male or female and 18 years of age or older.\n3. Subjects who are scheduled to undergo elective general surgery including, but not limited to the following surgical types:\n\n * Abdominal surgery\n * Orthopedic surgery\n * Spine surgery\n * Genitourinary surgery\n4. Subjects classified as American Society of Anesthesiologists (ASA class I-III).\n5. Female subjects are eligible only if all of the following apply:\n\n * Not pregnant (subjects of child bearing potential must have a negative beta human chorionic gonadotropin (β-hCG) pregnancy test before surgery);\n * Not lactating;\n * Not planning to become pregnant within the duration of the study;\n6. Subjects who are expected to have acute pain requiring oral opioid analgesics for at least 48 hours during the post operative period (either inpatient or outpatient).\n7. Subjects who are willing and capable of understanding and cooperating with the requirements of the study.\n8. Subjects able to understand and communicate in English.\n\nExclusion Criteria:\n\n1\\. Subjects with a medical condition that, in the Investigator's opinion, could adversely impact the subject's participation, safety, or conduct of the study such as but not limited to a history of severe renal or hepatic impairment, severe active hepatic disease, or any other clinically significant medical condition that may preclude safe study participation."}, 'identificationModule': {'nctId': 'NCT02381132', 'briefTitle': 'A Randomized, Open Label, Prospective Study to Explore the Clinical Characteristics of Oral MNK155 and Norco 7.5mg/325 When Used for the Treatment of Moderate to Severe Post Operative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Lotus Clinical Research, LLC'}, 'officialTitle': 'A Randomized, Open Label, Prospective Study to Explore the Clinical Characteristics of Oral MNK155 and Norco 7.5mg/325 When Used for the Treatment of Moderate to Severe Post Operative Pain', 'orgStudyIdInfo': {'id': 'LCR-MNK-155-01C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MNK155', 'description': 'Hydrocodone Bitartrate/Acetaminophen Extended-Release Tablets', 'interventionNames': ['Drug: MNK155']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Norco 7.5mg/325mg', 'description': 'Norco 7.5mg/325mg', 'interventionNames': ['Drug: Norco 7.5mg/325']}], 'interventions': [{'name': 'Norco 7.5mg/325', 'type': 'DRUG', 'armGroupLabels': ['Norco 7.5mg/325mg']}, {'name': 'MNK155', 'type': 'DRUG', 'armGroupLabels': ['MNK155']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Lotus Clinical Research, LLC', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neil Singla', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mallinckrodt', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Coordinating Investigator', 'investigatorFullName': 'Neil Singla', 'investigatorAffiliation': 'Lotus Clinical Research, LLC'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-08-14', 'type': 'RELEASE'}, {'date': '2020-08-31', 'type': 'RESET'}, {'date': '2021-03-05', 'type': 'RELEASE'}, {'date': '2021-03-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mallinckrodt'}}}}