A Phase 2 Study to Evaluate Safety and Efficacy of EB-001 Intramuscular (IM) Injections in Reducing Musculoskeletal Pain in Subjects Undergoing Elective Abdominoplasty Surgery
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Area Under the Curve (AUC) of Participant's Assessment of Pain Using the Numerical Pain Rating Scale (NPRS) at Rest Between 12 and 96 Hours Postsurgery (AUC12-96)
研究概览
简要总结
To determine the safety and efficacy of single intra-operative treatment of Botulinum Neurotoxin Serotype E (EB-001) intramuscular (IM) injections into the Rectus Abdominus (RA) in participants undergoing abdominoplasty.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 23 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women 23 to 55 years of age, inclusive
- •Scheduled to undergo elective abdominoplasty surgery with full length plication from xyphoid to pubis, and removal of skin/fat flap under general anesthesia (endotracheal or otherwise) without liposuction
- •American Society of Anesthesiologist (ASA) Physical Class 1-2.
排除标准
- •History of prior major abdominal surgery as judged by the investigator
- •Pre-existing lung disease that could impact participant safety in the opinion of the investigator
- •Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton- Lambert syndrome, or amyotrophic lateral Sclerosis)
- •At high risk of deep vein thrombosis as judged by the investigators determined by a Caprini score of 3 or higher
- •Slow vital capacity that is below 80% of normal value for respective race, age, height, and gender or below 2.5 Liters (L) of absolute volume
- •Pulse oximetry below 95%
- •Body weight less than 50 kg (110 pounds) or a Body Mass Index (BMI) of ≥ 32
- •Reported use of any botulinum toxin within 3 months prior to the date of surgery
- •Use of long acting opioids within 3 days or any opioid medication within 24 hours prior to surgery
- •Aminoglycoside intake within 48 hours prior to or during surgery
- •Participants on anti-depressant or anti-psychotic medications
- •Reported pain score of 2 or more at screening on the 11-point scale numerical pain rating scale-administered after an activity (NPRS-A) following an activity after and walking approximately 10 feet.
研究组 & 干预措施
Placebo
Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.
干预措施: Placebo (Drug)
Botulinum Neurotoxin Serotype E Dose 1
Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
干预措施: Botulinum Neurotoxin Serotype E (Biological)
Botulinum Neurotoxin Serotype E Dose 2
Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.
干预措施: Botulinum Neurotoxin Serotype E (Biological)
Botulinum Neurotoxin Serotype E Dose 3
Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
干预措施: Botulinum Neurotoxin Serotype E (Biological)
结局指标
主要结局
Area Under the Curve (AUC) of Participant's Assessment of Pain Using the Numerical Pain Rating Scale (NPRS) at Rest Between 12 and 96 Hours Postsurgery (AUC12-96)
时间窗: Every 2 hours from 12 to 96 hours postsurgery
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
次要结局
- AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 72 Hours Postsurgery (AUC0-72)(Every 2 hours from 0 to 72 hours postsurgery)
- AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 12 and 24 Hours Postsurgery (AUC12-24)(Every 2 hours from 12 to 24 hours postsurgery)
- AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 48 Hours Postsurgery (AUC0-48)(Every 2 hours from 0 to 48 hours postsurgery)
- AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 96 Hours Postsurgery(Every 2 hours from 0 to 96 hours postsurgery)
- AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 24 Hours Postsurgery (AUC0-24)(Every 2 hours from 0 to 24 hours postsurgery)
- Participants Overall Assessment of Pain Using the NPRS After Discharge(Days 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24 and 26)
- Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A)(8, 16, 24, 30, 36, 42, 48, 54, 60, 66, 72.78.84, and 96 hours after surgery; Days 8, 15 and 29 after discharge)
- Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories(Days 5, 8, 15 and 29)
- Number of Doses of Rescue Medications Used(Up to 96 hours postsurgery)