Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-27 @ 1:30 AM
Study NCT ID:
NCT05412992
Status:
TERMINATED
Last Update Posted:
2025-12-24
First Post:
2022-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The sponsor, the investigator, personnel at the clinical study unit who are directly involved with monitoring and/or performing study procedures and assessments, and the subjects will be blinded to treatment assignment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomized in 1:1 ratio to receive DMTS or matching placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'whyStopped': 'The SMC recommended stopping the trial. hemodynamic effects.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2022-06-01', 'studyFirstSubmitQcDate': '2022-06-07', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-interval weighted summed pain intensity (SPI) at designated time points', 'timeFrame': '5 to 96 hours following surgery', 'description': 'The SPI measured using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain'}], 'secondaryOutcomes': [{'measure': 'Time-interval weighted summed pain intensity (SPI) over various time intervals', 'timeFrame': '5 to 96 hours following surgery', 'description': 'The SPI measured using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain, measured at rest over various time intervals'}, {'measure': 'Rescue Medication', 'timeFrame': 'Up to 96 hours post surgery', 'description': 'The proportion of subjects using rescue analgesic medication'}, {'measure': 'Rescue Medication units', 'timeFrame': 'Up to 96 hours post surgery', 'description': 'Total dose of rescue analgesic medication (in morphine-equivalent units)'}, {'measure': 'Integrated Pain score and Rescue Medication', 'timeFrame': 'Up to 96 hours post surgery', 'description': 'Integrated assessment of summed pain intensity (SPI) using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain, at the time Rescue Medication was administered'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abdominoplasty', 'Pain', 'Transdermal', 'DMTS'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the analgesic efficacy of DMTS, compared with placebo, in subjects following abdominoplasty.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled, one-time application study of DMTS or matching placebo over a 4-day treatment period (Day 1 Time 0 occurs when the DMTS or matching placebo systems have been applied). Subjects scheduled for an abdominoplasty will be screened up to 28 days prior to surgery. Eligible subjects will be randomized equally to treatment with DMTS or matching placebo. An independent safety monitoring committee will periodically review unblinded safety data to confirm the safety/tolerability of the dose or recommend a dose reduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, ≥ 18 years of age.\n* Scheduled to undergo a full abdominoplasty (including repair of small incidental abdominal hernias, but not including liposuction).\n* Have a physical status classification of 1 or 2 per the American Society of Anesthesiology.\n* Have a body weight \\> 58 kg, and body mass index of 20 to 38 kg/m2, inclusive.\n\nExclusion Criteria:\n\n* Known sensitivity to dexmedetomidine or any excipient in the DMTS/placebo or to any peri- or postoperative medication whose use is required in this study.\n* Skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS/matching placebo application site, according to examination by the investigator at screening or admission to the clinic prior to surgery.\n* History of deep vein thrombosis or factor V Leiden deficiency.\n* History of syncope or other syncopal attacks.\n* Present and/or significant history of postural hypotension (determined through examination by the investigator or designee), or history of severe dizziness or fainting on standing in the opinion of the investigator.\n* Evidence of a clinically significant 12-lead ECG abnormality.'}, 'identificationModule': {'nctId': 'NCT05412992', 'acronym': 'DMT2111', 'briefTitle': 'Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teikoku Pharma USA, Inc.'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty', 'orgStudyIdInfo': {'id': 'TPU-DMT-02-2111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DMTS Patch', 'description': 'DMTS applied to upper outer arm', 'interventionNames': ['Drug: DMTS Patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Patch', 'description': 'Placebo system (with no drug) to match DMTS applied to the upper arm', 'interventionNames': ['Drug: Placebo Patch']}], 'interventions': [{'name': 'DMTS Patch', 'type': 'DRUG', 'otherNames': ['DMTS'], 'description': 'DMTS applied before surgery and worn for 96 hours', 'armGroupLabels': ['DMTS Patch']}, {'name': 'Placebo Patch', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Matching patches that have no active drug applied before surgery and worn for 96 hours', 'armGroupLabels': ['Placebo Patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials, LLC', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'JBR Clinical Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'James Song, MS, MA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teikoku Pharma USA, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan is in place to share individual participant data at this time.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teikoku Pharma USA, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}