A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011, HTX-002, or HTX-009 for Postoperative Analgesia Following Bunionectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 430
- 试验地点
- 5
- 主要终点
- Mean Summed Pain Intensity (SPI) Score Over 24 Hours
研究概览
简要总结
A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
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 each 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, and HTX-009, a meloxicam-only formulation in the same HTX-011 proprietary polymer, were evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Be male or female 18 years of age or older
- •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 test at screening and negative urine pregnancy test before surgery)
- •Not lactating
- •Not planning to become pregnant while participating in the study
- •Be surgically sterile; or be at least two years post-menopausal; or have a monogamous partner who is surgically sterile; or be 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 and for 30 days from completion 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 until at least 1 week after the administration of study medication
- •Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia
- •Subject has not had a contralateral bunionectomy in the non-study foot in the past 3 months
- •Have the ability and be willing to comply with the study procedures.
- •Must be able to understand study procedures and give informed consent for the conduct for all study procedures, using an IRB approved consent form
排除标准
- •Unwilling to sign informed consent or not willing or able to complete all study procedures
- •Have a contraindication or be allergic to any medication to be used during the trial period
- •Have clinically significant cardiac abnormalities that, in the opinion of the investigator, would pose a health risk to the subject
- •Have American Society of Anesthesiologists (ASA) Physical Status classification system category ≥4
- •Have clinically significant renal or hepatic abnormalities: for example, AST or ALT > 3x ULN, creatinine > 2x ULN
- •Have another pre-existing painful condition that may confound pain assessments
- •Have another surgery planned within 30 days of procedure
- •Have a known or suspected history of alcohol or drug abuse, or a positive drug screen
- •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 scheduled surgery for this study
- •Subjects with documented sleep apnea or are on home continuous positive airway pressure (CPAP)
- •Subjects who are receiving oxygen therapy at the time of screening
- •Have participated in a clinical trial within 30 days of planned surgery
研究组 & 干预措施
HTX-011A: 200 mg
HTX-011A (bupivacaine/meloxicam), 200 mg/6 mg via injection.
干预措施: HTX-011A (Drug)
HTX-011B: 30 mg
HTX 011B (bupivacaine/meloxicam), 30 mg/0.9 mg via injection.
干预措施: HTX-011B (Drug)
HTX-011B : 60 mg
HTX-011B (bupivacaine/meloxicam) 60 mg/1.8 mg via injection or instillation.
干预措施: HTX-011B (Drug)
HTX-011B: 120 mg
HTX- 011B (bupivacaine/meloxicam), 120 mg/3.6 mg via injection or instillation.
干预措施: HTX-011B (Drug)
HTX-011B: 200 mg
HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection.
干预措施: HTX-011B (Drug)
Bupivacaine HCI
Bupivacaine HCI, 50 mg via injection.
干预措施: Bupivacaine HCl (Drug)
Saline Placebo
Saline placebo via injection.
干预措施: Saline Placebo (Biological)
HTX-002, 60 mg
HTX- 002, 60 mg via injection.
干预措施: HTX-002 (Drug)
HTX-002, 120 mg
HTX-002, 120 mg via injection.
干预措施: HTX-002 (Drug)
HTX-002, 200 mg
HTX-002, 200 mg via injection.
干预措施: HTX-002 (Drug)
HTX-009
HTX-009, 3.6 mg via injection.
干预措施: HTX-009 (Drug)
结局指标
主要结局
Mean Summed Pain Intensity (SPI) Score Over 24 Hours
时间窗: 0-24 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