Dose-Escalation Study of HTX-034 Following Bunionectomy
NCT ID: NCT04398329
Last Updated: 2022-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
73 participants
INTERVENTIONAL
2020-05-18
2021-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Phase 1b (Cohort 1)
Fixed dose of HTX-034.
HTX-034
HTX-034, low dose
Luer lock applicator
Applicator for instillation
Phase 1b (Cohort 2)
Individualized dose of HTX-034.
HTX-034
HTX-034, high dose
Luer lock applicator
Applicator for instillation
Phase 2 (Expansion): Low Dose
Fixed dose of HTX-034.
HTX-034
HTX-034, low dose
Luer lock applicator
Applicator for instillation
Phase 2 (Expansion): High Dose
Individualized dose of HTX-034.
HTX-034
HTX-034, high dose
Luer lock applicator
Applicator for instillation
Phase 1b and Phase 2
Bupivacaine HCl.
Bupivacaine HCl
Bupivacaine HCl, 50 mg
Interventions
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HTX-034
HTX-034, low dose
HTX-034
HTX-034, high dose
Luer lock applicator
Applicator for instillation
Bupivacaine HCl
Bupivacaine HCl, 50 mg
Eligibility Criteria
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Inclusion Criteria
* Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
* Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study; sterile, or using acceptable contraceptives.
Exclusion Criteria
* Has a planned concurrent surgical procedure.
* Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
* Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
* Has received or is taking a contraindicated or prohibited medications.
* Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
* Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.
* Has a history of clinically significant cardiac abnormality such as myocardial infarction within 6 months.
* Has a history of coronary artery bypass graft surgery within 12 months.
* Has a history of known or suspected coagulopathy.
* As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).
* Has uncontrolled anxiety, psychiatric, or neurological disorder.
* Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
* Has undergone 3 or more surgeries within 12 months.
* Has a known history of glucose-6-phosphate dehydrogenase deficiency.
* Has any of the following laboratory abnormalities during Screening (1 retest permitted):
* Severe liver function impairment.
* Severe kidney function impairment.
* Platelet count \<100,000/μL, hemoglobin \<12 g/dL, or hematocrit \<35%.
* Has a body mass index (BMI) \>39 kg/m2.
18 Years
ALL
No
Sponsors
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Heron Therapeutics
INDUSTRY
Responsible Party
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Locations
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Arizona Research Center
Phoenix, Arizona, United States
First Surgical Hospital
Bellaire, Texas, United States
Endeavor Clinical Trials, LLC
San Antonio, Texas, United States
JBR Clinical Research
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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HTX-034-101
Identifier Type: -
Identifier Source: org_study_id
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