Dose-Escalation Study of HTX-034 Following Bunionectomy
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
1 other identifier
interventional
73
1 country
4
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 additional subjects treated with the HTX-034 dose selected based on Phase 1b compared with bupivacaine HCl.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2020
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2020
CompletedStudy Start
First participant enrolled
May 18, 2020
CompletedFirst Posted
Study publicly available on registry
May 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2021
CompletedFebruary 15, 2022
January 1, 2022
1.1 years
May 18, 2020
January 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Treatment-emergent adverse events (TEAE's) (Phase 1B)
42 days
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 Outcomes (9)
Maximum plasma concentration (Cmax) of HTX-034
29 days
Time of maximum plasma concentration (Tmax) of HTX-034
29 days
Area under the concentration-time curve from Time 0 to the time of the last quantitative concentration (AUClast) of HTX-034
29 days
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of HTX-034 (Phase 1B)
22 days
Apparent terminal half-life (t½) of HTX-034 (Phase 1B)
22 days
- +4 more secondary outcomes
Study Arms (5)
Phase 1b (Cohort 1)
EXPERIMENTALFixed dose of HTX-034.
Phase 1b (Cohort 2)
EXPERIMENTALIndividualized dose of HTX-034.
Phase 2 (Expansion): Low Dose
EXPERIMENTALFixed dose of HTX-034.
Phase 2 (Expansion): High Dose
EXPERIMENTALIndividualized dose of HTX-034.
Phase 1b and Phase 2
ACTIVE COMPARATORBupivacaine HCl.
Interventions
Applicator for instillation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Arizona Research Center
Phoenix, Arizona, 85053, United States
First Surgical Hospital
Bellaire, Texas, 77401, United States
Endeavor Clinical Trials, LLC
San Antonio, Texas, 78229, United States
JBR Clinical Research
Salt Lake City, Utah, 84017, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2020
First Posted
May 21, 2020
Study Start
May 18, 2020
Primary Completion
July 1, 2021
Study Completion
August 3, 2021
Last Updated
February 15, 2022
Record last verified: 2022-01