Dose-Escalation Study of HTX-034 Following Bunionectomy

Bunions Clinical Trial

Official title:

A Phase 1b/2, Randomized, Blinded, Active-Controlled Study of Escalating Doses of HTX-034 for Postoperative Analgesia in Subjects Undergoing Unilateral, First Metatarsal Bunionectomy With Osteotomy and Internal Fixation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04398329
• Other study ID #: HTX-034-101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 18, 2020
• Est. completion date: August 3, 2021

Study information

• Verified date: January 2022
• Source: Heron Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 additional subjects treated with the HTX-034 dose selected based on Phase 1b compared with bupivacaine HCl.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 3, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Bunion
• Bunions

Intervention

Drug:
• HTX-034
HTX-034, low dose
• HTX-034
HTX-034, high dose

Device:
• Luer lock applicator
Applicator for instillation

Drug:
• Bupivacaine HCl
Bupivacaine HCl, 50 mg

Locations

Country	Name	City	State
United States	First Surgical Hospital	Bellaire	Texas
United States	Arizona Research Center	Phoenix	Arizona
United States	JBR Clinical Research	Salt Lake City	Utah
United States	Endeavor Clinical Trials, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Heron Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-emergent adverse events (TEAE's) (Phase 1B)		42 days
Primary	Mean area under the curve (AUC) of the NRS scores through 72 hours (AUC0-72) for the pooled Phase 1b and Phase 2		7 days
Secondary	Maximum plasma concentration (Cmax) of HTX-034		29 days
Secondary	Time of maximum plasma concentration (Tmax) of HTX-034		29 days
Secondary	Area under the concentration-time curve from Time 0 to the time of the last quantitative concentration (AUClast) of HTX-034		29 days
Secondary	Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of HTX-034 (Phase 1B)		22 days
Secondary	Apparent terminal half-life (t½) of HTX-034 (Phase 1B)		22 days
Secondary	Mean AUC of the NRS pain intensity scores		7 days
Secondary	Total postoperative opioid consumption (in IV Morphine Milligram Equivalents)		7 days
Secondary	Proportion of subjects who are opioid-free		14 days
Secondary	Incidence of serious adverse Events (SAE's)		42 days