Status:
COMPLETED
Dose-Escalation Study of HTX-034 Following Bunionectomy
Lead Sponsor:
Heron Therapeutics
Conditions:
Bunions
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b will evaluate escalating doses of HTX-034 compared with bupivacaine HCl. Phase 2 will be a dose-expansion phase to evaluate...
Eligibility Criteria
Inclusion
- Is medically fit to undergo an elective unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia; no neuraxial technique (eg, no spinal, epidural, or general anesthesia).
- 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
- Had contralateral foot bunionectomy in the past 3 months.
- 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.
Key Trial Info
Start Date :
May 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2021
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04398329
Start Date
May 18 2020
End Date
August 3 2021
Last Update
February 15 2022
Active Locations (4)
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1
Arizona Research Center
Phoenix, Arizona, United States, 85053
2
First Surgical Hospital
Bellaire, Texas, United States, 77401
3
Endeavor Clinical Trials, LLC
San Antonio, Texas, United States, 78229
4
JBR Clinical Research
Salt Lake City, Utah, United States, 84017