A Phase 2, Randomized, Controlled Evaluation of the Efficacy and Safety of HTX-011 or HTX-002 for Post-Operative Analgesia Following Abdominoplasty Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 277
- 主要终点
- Summed Pain Intensity Scores Collected Over 24 Hours
研究概览
简要总结
A Phase 2, Randomized, Controlled Evaluation of the Efficacy and Safety of HTX-011 or HTX-002 for Post-Operative Analgesia Following Abdominoplasty Surgery
详细描述
This study includes multiple formulations for formulation selection of the fixed-combination product and for the factorial design assessment of the contribution of the bupivacaine component. HTX-011A is the second formulation studied (HTX-011-49). HTX-011B is the final formulation studied (HTX-011-56), which was also included in subsequent Phase 2b and Phase 3 studies. For the factorial design assessment, HTX-002, a bupivacaine-only formulation in the same HTX-011 proprietary polymer was evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet all of the following criteria to be considered eligible to participate in the study:
- •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:
- •Not pregnant (female subject of child bearing potential must have a negative serum pregnancy tests at screening and negative urine pregnancy test before surgery)
- •Not lactating
- •Not planning to become pregnant during the study
- •Be surgically sterile; or at least two years post-menopausal; or have a monogamous partner who is surgically sterile; or is practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening visits and commits to the use of an acceptable form of birth control for the duration of the study
- •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
- •Must be able to understand study procedures and be willing to comply and give informed consent for the conduct of all study procedures, using an IRB approved consent
排除标准
- •Subjects who meet any of the following criteria will be excluded from participating in the study:
- •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
- •Subjects taking the following medications; anticonvulsants, sedatives (including benzodiazepines) corticosteroids (by any means of administration), nonsteroidal anti-inflammatory drugs (NSAIDS) within 24 hours of study drug dosing, morphine, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin-norepinephrine reuptake inhibitors (SNRIs). Gabapentin and pregabalin are not permitted
- •Have a known or suspected history of alcohol or drug abuse
- •Have positive results on the alcohol breath test indicative of alcohol abuse or urine drug screen indicative of illicit drug use (unless results can be explained by a current prescription or acceptable over-the-counter medication at screening as determined by the investigator). The urine drug screen prior to surgery must be negative
- •Have evidence of a clinically significant 12-lead ECG abnormality according to the judgment of the investigator
- •Have received any investigational product within 30 days before start of study
- •Have previously received HTX-011 in clinical trials
- •Experiences a clinically significant event during surgery prior to the administration of the investigational product (e.g., excessive bleeding, hemodynamic instability) that would render the subject medically unstable, complicate their post-surgical course, or significantly increase the risk of study drug administration as per the judgment of the investigator. This will result in the subject being reported as randomized, not treated.
- •Subjects with sleep apnea or are on home continuous positive airway pressure (CPAP)
- •Subjects who are receiving oxygen therapy at the time of screening
研究组 & 干预措施
Part A, Cohort C: HTX-011B
HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection
干预措施: HTX-011B (Drug)
Part A, Cohort A: HTX-011A
HTX- 011A (bupivacaine/meloxicam), 200 mg/6 mg via injection
干预措施: HTX-011A (Drug)
Parts A and B, Cohort B: Saline Placebo
Saline placebo via injection
干预措施: Placebo (Drug)
Part A, Cohort D: HTX-011B
HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via injection
干预措施: HTX-011B (Drug)
Part A, Cohort E: HTX-011B
HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via combination
干预措施: HTX-011B (Drug)
Part A, Cohort F: HTX-011B
HTX- 011B (bupivacaine/meloxicam), 600 mg/18 mg via injection
干预措施: HTX-011B (Drug)
Part B, Cohort A: HTX-002
HTX-002, 400 mg via combination
干预措施: HTX-002 (Drug)
Part C, Cohort A: HTX-011B
HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via instillation
干预措施: HTX-011B (Drug)
Part C, Cohort B: HTX-011B
HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via combination
干预措施: HTX-011B (Drug)
Part C, Cohort C: HTX-011B
HTX-011B (bupivacaine/meloxicam), 300 mg/9 mg via combination
干预措施: HTX-011B (Drug)
Part C, Cohort D: Bupivacaine HCI
Bupivacaine HCl, 100 mg via injection
干预措施: Bupivicaine HCl (Drug)
Part C, Cohort E: Saline Placebo
Saline placebo via injection
干预措施: Placebo (Drug)
结局指标
主要结局
Summed Pain Intensity Scores Collected Over 24 Hours
时间窗: 24 hours
The SPI is derived by summing the pain intensity score weighted by the scheduled time duration. SPI0-24 will be calculated by summing the Pain intensity (PI) score at the relevant time points weighted by the scheduled time duration since the prior PI assessment as follows: SPI0-24= PI1+PI2+2\*PI4+2\*PI6+2\*PI8+2\*PI10+2\*PI12+2\*PI14+4\*PI18+6\*PI24. Min = 0 (if PI=0 at every time) and Max = 240 (if PI=10 at every time).
次要结局
未报告次要终点