Evaluation of the Efficacy and Safety of HTX-011 for Postoperative Analgesia Following Abdominopl… (NCT02689258) | Clinical Trial Compass
CompletedPhase 2
Evaluation of the Efficacy and Safety of HTX-011 for Postoperative Analgesia Following Abdominoplasty Surgery
United States277 participantsStarted 2016-02-23
Plain-language summary
A Phase 2, Randomized, Controlled Evaluation of the Efficacy and Safety of HTX-011 or HTX-002 for Post-Operative Analgesia Following Abdominoplasty Surgery
Who can participate
Age range
18 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
. Be scheduled to undergo abdominoplasty surgery that is amenable to treatment with a long acting local anesthetic as per the anesthesia protocol
. Be American Society of Anesthesiology (ASA) physical Class I or II
. Subjects 18 years of age or older
. Have clinical laboratory values that are within normal limits (WNL); subjects with AST/ALT \< 3 x ULN, and/or creatinine \< 2 x ULN are acceptable.
. Have a body mass index ≤ 30 kg/m2
. Female subjects are eligible only if all of the following apply:
. Male subjects 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
. Does NOT 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
Exclusion criteria
. Have a contraindication or be allergic to any medication to be used during the trial period
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.
What they're measuring
1
Summed Pain Intensity Scores Collected Over 24 Hours
. Have another painful physical condition that, in the opinion of the investigator, may confound the assessments of post-operative pain
. Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants
. Currently taking analgesics for a chronically painful condition, or has taken long acting opioids within 3 days of surgery, or taken any opioids within 24 hours of surgery
. Previous abdominal surgery, as determined by the investigator, that would preclude participation in the study
. Subjects that require liposuction as part of the abdominoplasty procedure in Part A of the protocol
. Subjects that are to have ancillary procedures performed during the abdominoplasty surgery that are unrelated to the abdominal area (breast reduction, breast augmentation, etc.)
. Subjects unable to discontinue medications that have not been at a stable dose for at least 14 days prior to the scheduled abdominoplasty procedure and before dosing with investigational product