HTX-011 for Post-bunionectomy Analgesia (NCT02471898) | Clinical Trial Compass
CompletedPhase 2
HTX-011 for Post-bunionectomy Analgesia
United States71 participantsStarted 2015-06
Plain-language summary
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Two-Part Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily provide written informed consent.
. Male or female between 18 and 65 years of age, inclusive.
. Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia
. Be American Society of Anesthesiology (ASA) physical Class 1 or 2.
. Female subjects are eligible only if all of the following apply:
. Male patients 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.
. Have a body mass index ≤ 35 kg/m2.
. Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program.
Exclusion criteria
. Have a known allergy to Bupivacaine/Meloxicam or any HTX-011/placebo excipient or to any peri- or postoperative medications used in this study including oxycodone lidocaine, propofol, fentanyl, and midazolam.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Have a clinically significant abnormal clinical laboratory test value according to the judgment of the investigator.
. Have history of or positive test results for HIV or hepatitis B or C at screening.
. Have, as determined by the investigator or the study's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
. Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
. Have another painful physical condition that, in the opinion of the investigator, may confound the assessments of postoperative pain.
. Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of study treatment initiation.
. Use concurrent therapy that could interfere with the evaluation of efficacy or safety, such as any drugs which in the investigator's opinion may exert significant analgesic properties or act synergistically with HTX-011-19.