Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-03-28 @ 8:11 PM
Study NCT ID:
NCT00728832
Status:
COMPLETED
Last Update Posted:
2008-08-14
First Post:
2008-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'lastUpdateSubmitDate': '2008-08-12', 'studyFirstSubmitDate': '2008-08-01', 'studyFirstSubmitQcDate': '2008-08-05', 'lastUpdatePostDateStruct': {'date': '2008-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the serum pharmacokinetic profile of a single 15-mg dose of DepoDur administered at the lower thoracic epidural space with or without a prior lidocaine-epinephrine test dose'}], 'secondaryOutcomes': [{'measure': 'efficacy and safety profiles'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['extended release epidural morphine', 'morphine', 'thoracic epidural', 'pharmacokinetics', 'pharmacodynamics', 'postoperative pain', 'upper abdominal surgery'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '19840530', 'type': 'DERIVED', 'citation': 'Viscusi ER, Manvelian GZ. A randomized study of the serum pharmacokinetics of lower thoracic extended-release epidural morphine (DepoDur) after lidocaine-epinephrine test dose administration in patients undergoing upper abdominal surgery. Int J Clin Pharmacol Ther. 2009 Nov;47(11):659-70. doi: 10.5414/cpp47659.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the effects of lidocaine/epinephrine test dose administration on the PK profile of a single epidural dose of DepoDur (extended-release epidural morphine) in patients undergoing major upper abdominal surgery. A secondary objective was to evaluate the safety and efficacy profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females ≥ 18 years of age at Screening\n* Negative pregnancy test in females of childbearing potential\n* Scheduled for major upper abdominal surgery via an upper midline incision under general anesthesia\n* American Society of Anesthesiology (ASA) Physical Class 1, 2, or 3\n* Willing and able to use a PCA pump\n* Willing to receive only IV fentanyl for 72 hours post-dose to control post-operative pain\n* Capable of providing written informed consent and responses to pain assessment scales and neurological assessment questionnaires\n\nExclusion Criteria:\n\n* Morbid obesity, defined as a body mass index (BMI) ≥ 40\n* Scheduled to undergo surgery under regional anesthesia\n* Usage of analgesic medications containing morphine or codeine within three days prior to study drug administration\n* Chronic opioid medication usage (defined as daily opioids for more than 7 days prior to enrollment)\n* Suspected or documented history of sleep apnea, narcolepsy, or excessive daytime sleepiness\n* Female who was pregnant or lactating\n* History of hypersensitivity or idiosyncratic reaction to opioid medications, local anesthetics, or epinephrine\n* Any contraindication for the epidural administration of study drug (e.g., coagulopathy, local infection)\n* Administration of an investigational drug within 30 days prior to Screening\n* Suspected or documented history of substance abuse and/or alcoholism\n* Any contraindication to frequent blood PK sampling (such as significant anemia) or other barrier to obtaining timely PK samples'}, 'identificationModule': {'nctId': 'NCT00728832', 'briefTitle': 'A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'EKR Therapeutics, Inc'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Effects of Lidocaine/Epinephrine Test Dose Administration on the Pharmacokinetic Profile of a Single Dose of Thoracic Extended-Release Epidural Morphine in Patients Undergoing Major Upper Abdominal Surgery', 'orgStudyIdInfo': {'id': 'SKY0401-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'No test dose + DepoDur + flush with 1 mL normal saline', 'interventionNames': ['Drug: DepoDur (extended-release epidural morphine)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Test dose + flush with 1 mL normal saline + 3-minute wait + DepoDur + flush with 1 mL normal saline', 'interventionNames': ['Drug: DepoDur (extended-release epidural morphine)']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Test dose + flush with 1 mL normal saline + 10-minute wait + DepoDur + flush with 1 mL normal saline', 'interventionNames': ['Drug: DepoDur (extended-release epidural morphine)']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Test dose + flush with 1 mL normal saline + 15-minute wait + DepoDur + flush with 1 mL normal saline', 'interventionNames': ['Drug: DepoDur (extended-release epidural morphine)']}, {'type': 'EXPERIMENTAL', 'label': '5', 'description': 'Test dose + No flush + 3-minute wait + DepoDur + flush with 1 mL normal saline', 'interventionNames': ['Drug: DepoDur (extended-release epidural morphine)']}], 'interventions': [{'name': 'DepoDur (extended-release epidural morphine)', 'type': 'DRUG', 'description': 'DepoDur with on demand boluses of IV fentanyl PCA', 'armGroupLabels': ['1', '2', '3', '4', '5']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Eugene R Viscusi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EKR Therapeutics, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pacira Pharmaceuticals, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Eugene R. Viscusi, MD', 'oldOrganization': 'Thomas Jefferson University'}}}}