Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:47 AM
Study NCT ID:
NCT05100160
Status:
WITHDRAWN
Last Update Posted:
2023-04-13
First Post:
2021-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': '0 patient accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2021-09-22', 'studyFirstSubmitQcDate': '2021-10-27', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo', 'timeFrame': 'through study completion, up to 8 days', 'description': 'The sum of the daily average morphine equivalent dose of opioids recorded from day of surgery (day 0) through 7 days after surgery, for a total of 8 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thoracic', 'Pulmonary Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. We have defined clinically meaningful as a reduction by 30 Morphine equivalent doses (MED)', 'detailedDescription': 'Study Objectives:\n\nThe aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. We have defined clinically meaningful as a reduction by 25% Morphine equivalent doses (MED) Secondary objectives are to evaluate the utility of gabapentin in reducing postoperative pain, reducing hospital length of stay, promoting faster return to baseline function (to be assessed by MDASI), preventing post thoracotomy pain syndrome (to be assessed by BPI), and reducing the rate of chronic opiate use among patients undergoing thoracic procedures.\n\n1. Primary Endpoint\n\n The primary outcome will be the sum of the daily average morphine equivalent dose of opioids recorded from day of surgery (day 0) through 7 days after surgery, for a total of 8 days.\n2. Secondary Endpoints\n\n * Time to resuming normal activities\n * Presence/absence of chronic pain at 3 and 6 months, measured by BPI\n * 30, 90, 180 day opiate use (Y/N)\n * MDASI on post-operative days 7, 30, 90, 180\n * Basic Pain Inventory (BPI) on post-operative days 1,2, 7, 30, 90, 180\n * Daily pain score during hospitalization\n * Length of hospital stay\n * Need for opioids at discharge\n * Whether medication is stopped prior to day 25, and if so when and for what reason.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18+\n* Undergoing pulmonary resection (includes metastasectomy as well as anatomic resections)\n* Must have device with email capabilities for follow up survey\n\nExclusion Criteria:\n\n* Requiring narcotic pain medication or Gabapentin at the time of preoperative appointment or within 30 days of surgery\n* Renal impairment requiring dialysis\n* Allergy to Gabapentin'}, 'identificationModule': {'nctId': 'NCT05100160', 'briefTitle': 'Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)', 'orgStudyIdInfo': {'id': '2021-0653'}, 'secondaryIdInfos': [{'id': 'NCI-2021-10727', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Trials Reporting Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gabapentin', 'description': 'used as part of a multimodal pain regimen (combination of drugs used to control pain', 'interventionNames': ['Drug: Gabapentin']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'designed to be compared with a study drug to learn if the study drug has any real effect', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Gabapentin', 'type': 'DRUG', 'description': 'Given by PO', 'armGroupLabels': ['Gabapentin']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Given by PO', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'David Rice', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}