Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-01-08 @ 9:56 PM
Study NCT ID:
NCT03838133
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2019-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety, PK, Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-12-23', 'mcpReleaseN': 6, 'releaseDate': '2021-11-24'}], 'estimatedResultsFirstSubmitDate': '2021-11-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006215', 'term': 'Hallux Valgus'}], 'ancestors': [{'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-06', 'studyFirstSubmitDate': '2019-02-11', 'studyFirstSubmitQcDate': '2019-02-11', 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC of numerical pain rating scale', 'timeFrame': '0-24 hours, 0-72 hours', 'description': 'AUC of numerical pain rating scale (NPRS-R) following bunionectomy surgery'}], 'secondaryOutcomes': [{'measure': 'PK Cmax', 'timeFrame': '0-168 hours', 'description': 'Maximum blood concentration (Cmax)'}, {'measure': 'PK Tmax', 'timeFrame': '0-168 hours', 'description': 'Time to reach maximum blood concentration (Tmax)'}, {'measure': 'PK t½', 'timeFrame': '0-168 hours', 'description': 'Terminal elimination half-life (t½)'}, {'measure': 'PK AUC', 'timeFrame': '0-24, 0-48 , 0-72, 0-96 hours', 'description': 'Area under the blood concentration-time curve (AUC)'}, {'measure': 'Number of treatment emergent adverse event (TEAE)', 'timeFrame': 'Screening through Day 43', 'description': 'Number of treatment emergent adverse event (TEAE) occurred in the study'}, {'measure': 'Electrocardiogram (RR interval, QRS duration, QT duration, PR duration, QTcF interval)', 'timeFrame': 'Screening through Day 43', 'description': 'The 12-lead electrocardiogram (ECG) result will be assessed including RR interval, QRS duration, QT duration, PR duration, and QTcF interval'}, {'measure': 'Wound assessment by Numerical Pain Rating Scale (NPRS)', 'timeFrame': 'Day 1 through Day 43', 'description': 'The surgical site will be examined by the investigator using a 5-point numerical pain rating scale as follows:\n\n1. Normal healing\n2. Bruising, erythema, edema\n3. Clear or hemoserous drainage\n4. Evidence of cellulitis such as heat, spreading erythema, purulent discharge\n5. Tissue breakdown, wound dehiscence, hematoma requiring aspiration'}, {'measure': 'AUC of NPRS-R (0-10)', 'timeFrame': '0-36, 0-48, 0-72, 0-96, 0-120,24-48, 48-72, 72-96, 96-120, and 120-168 hours', 'description': 'AUC of NPRS-R (0-10)'}, {'measure': 'Proportion of pain-free (NPRS-R of 0 or 1) subjects', 'timeFrame': 'at 12, 24, 36, 48, 72, 96, 120, and 168 hours', 'description': 'Proportion of pain-free (NPRS-R of 0 or 1) subjects'}, {'measure': 'Proportion of subjects who used no rescue opioid analgesic', 'timeFrame': 'through 12, 24, 36, 48, 72, 96, 120, and 168 hours', 'description': 'Proportion of subjects who used no rescue opioid analgesic'}, {'measure': 'Time to the first postoperative use of rescue opioid analgesics', 'timeFrame': 'Day 1 to Day 43', 'description': 'Time to the first postoperative use of rescue opioid analgesics'}, {'measure': 'Total postoperative consumption of rescue opioid analgesics used', 'timeFrame': 'through 24, 36, 48, 60, 72, 96, 120, and 168 hours', 'description': 'Total postoperative consumption of rescue opioid analgesics used'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hallux Valgus']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2, randomized, double-blind, 2-part comparator- and placebo-controlled study to evaluate the safety, PK, and efficacy of TLC590 via a single infiltrative local administration in adult subjects following bunionectomy.', 'detailedDescription': 'This is a Phase 2, randomized, double-blind, 2-part comparator- and placebo-controlled study to evaluate the safety, PK, and efficacy of TLC590 via a single infiltrative local administration in adult subjects following bunionectomy.\n\nThe primary objective of this study is to evaluate the analgesic efficacy of TLC590 for post-surgical pain management in subjects following bunionectomy.\n\nThe secondary objectives of this study are:\n\n* To evaluate the pharmacokinetic (PK) profile and dose-exposure relationship of TLC590, as well as the bioavailability as compared with Naropin®.\n* To evaluate the safety and tolerability of TLC590 for post-surgical pain management in subjects following bunionectomy.\n* To evaluate the exposure-response relationship between PK parameters and pain intensity.\n\nThe study will be divided into two parts:\n\nPart 1: Blinded Pharmacokinetics of TLC590 and Naropin®. Approximately 48 subjects will be randomized to treatments.\n\nPart 2: Efficacy and Safety of TLC590 versus bupivacaine and Placebo. Part 2 of the study will randomize approximately 150 evaluable subjects who meet all entry criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent.\n2. Male or female between 18 and 65 years of age.\n3. Body mass index ≤ 35 kg/m2.\n4. Mild to moderate hallux valgus deformity.\n5. Scheduled to undergo a primary, unilateral first metatarsal bunionectomy repair under local anesthesia.\n6. American Society of Anesthesiology Physical Status Classification of 1 or 2 at screening.\n7. Female subjects are eligible only if all of the following apply:\n\n * Not pregnant;\n * Not lactating;\n * Not planning to become pregnant during the study;\n * Commits to the use of an acceptable form of birth control for the duration of the study and for 42 days from administration of study drug.\n8. Male subjects must be surgically sterile (biologically or surgically) or commit to the use of a reliable method of birth control, for the duration of the study until at least 1 week after the administration of study medication.\n\nExclusion Criteria:\n\n1. Clinically significant abnormal clinical laboratory test value.\n2. Evidence of a clinically significant 12-lead ECG abnormality.\n3. History or evidence of orthostatic hypotension, syncope or other syncopal attacks.\n4. History or clinical manifestations of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.\n5. A history of seizure disorder or currently taking anticonvulsants.\n6. History of hypersensitivity to ropivacaine, any other amide-type local anesthetic, propofol, lidocaine, midazolam, acetaminophen, naproxen, morphine or oxycodone (or other opioids).\n7. Concurrent painful physical condition that may confound post-operative pain assessments.\n8. Persistent or recurrent nausea and/or vomiting due to other etiologies.\n9. History of severe or refractory post-operative nausea or vomiting (PONV) deemed clinically significant.\n10. History of alcohol abuse or prescription/illicit drug abuse within 2 years.\n11. Current evidence of alcohol abuse within 6 months.\n12. Received opioid therapy for longer than 4 days per week within 2 months or opioid use within 2 weeks.\n13. Use of concurrent therapy that could interfere with the evaluation of efficacy or safety.\n14. Unable to discontinue medications that have not been at a stable dose for at least 14 days prior to the study surgical procedure, within 5 half-lives of the specific prior medication.\n15. Use of any of the following medications within 5 half-lives or as specified prior to the study surgical procedure:\n\n * Low-dose aspirin therapy for cardiovascular protection\n * Class III antiarrhythmic drugs\n * Strong CYP1A2 inhibitors\n * CYP1A2 substrates\n * Strong CYP3A4 inhibitors\n * Corticosteroids, either systemically, inhaled either intranasally or orally, or by intra-articular injection, or NSAIDs within 14 days\n * Any investigational product within 30 days.\n16. Positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.\n17. History or positive test results for HIV; active Hepatitis B or C.\n18. Contralateral foot bunionectomy in the last 3 months or have collateral procedures.\n19. Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.\n20. History of rheumatoid disease, Type 1 or Type 2 diabetes or peripheral circulatory disorders.\n21. Documented sleep apnea or are on home continuous positive airway pressure.'}, 'identificationModule': {'nctId': 'NCT03838133', 'briefTitle': 'A Study to Evaluate Safety, PK, Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiwan Liposome Company'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy', 'orgStudyIdInfo': {'id': 'TLC590A1002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TLC590 dose 1 (152 mg)', 'description': 'TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.', 'interventionNames': ['Drug: TLC590']}, {'type': 'EXPERIMENTAL', 'label': 'TLC590 dose 2 (190 mg)', 'description': 'TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.', 'interventionNames': ['Drug: TLC590']}, {'type': 'EXPERIMENTAL', 'label': 'TLC590 dose 3 (228 mg)', 'description': 'TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.', 'interventionNames': ['Drug: TLC590']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Naropin®', 'description': 'Naronpin injection contains ropivacaine HCl 50 mg (0.5%, 10 mL)', 'interventionNames': ['Drug: Naropin®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Normal Saline (0.9% sodium chloride, 10 mL)', 'interventionNames': ['Drug: Normal Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine', 'description': 'Bupivacaine HCl 50 mg (0.5%, 10 mL)', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'TLC590', 'type': 'DRUG', 'otherNames': ['TLC590 (Ropivacaine Liposome Injectable Suspension)'], 'description': 'TLC590, a sustained-release formulation of the local anesthetics with lipid-based excipients', 'armGroupLabels': ['TLC590 dose 1 (152 mg)', 'TLC590 dose 2 (190 mg)', 'TLC590 dose 3 (228 mg)']}, {'name': 'Naropin®', 'type': 'DRUG', 'otherNames': ['Naropin, 0.5% Injectable Solution'], 'description': 'Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. 50 mg (0.5%, 10 mL)', 'armGroupLabels': ['Naropin®']}, {'name': 'Normal Saline', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'Normal Saline (0.9% sodium chloride, 10ml)', 'armGroupLabels': ['Placebo']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'Bupivacaine 50 mg (0.5%, 10 mL)', 'armGroupLabels': ['Bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials, LLC', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '21122-1020', 'city': 'Pasadena', 'state': 'Maryland', 'country': 'United States', 'facility': 'Chesapeake Research Group', 'geoPoint': {'lat': 39.119, 'lon': -76.57108}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Endeavor Clinical Trials', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84020', 'city': 'Draper', 'state': 'Utah', 'country': 'United States', 'facility': 'JBR clinical research', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}], 'overallOfficials': [{'name': 'Carl Brown, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taiwan Liposome Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiwan Liposome Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}