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 range18 Years

SexALL

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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
✕. 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

What they're measuring

Summed Pain Intensity Scores Collected Over 24 Hours

Timeframe: 24 hours

Trial details

NCT IDNCT02689258

SponsorHeron Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-03

Results submitted2021-06-11

View on ClinicalTrials.gov More Postoperative Pain trials