A Randomized, Double Blind, Placebo-Controlled, Single Dose Study to Assess The Safety and Efficacy of Intramuscular Sebacoyl Dinalbuphine Ester (SDE) for Post-Hemorrhoidectomy Pain Management
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 8
- 主要终点
- Pain Assessment Calculated as the Area Under the Curve of VAS Pain Intensity Scores Through 48 Hours After Surgery
研究概览
简要总结
This is a randomized, double blind, placebo-controlled, single dose study to assess the safety and efficacy of intramuscular sebacoyl dinalbuphine ester (SDE) for post-hemorrhoidectomy pain management.
详细描述
This study was a multicenter, double-blind, randomized, placebo-controlled, parallel, pretreatment study, sponsored by Lumosa therapeutics Co., Ltd (Taiwan). All subjects received training of visual analog scores (VAS) before surgery using the 10-mm horizontal version. VAS was taken by study subjects themselves before the first dose of PCA ketorolac, and at 1, 2, 3, 4, 8, 12, 16, 24, 28, 32, 36, 40, 44, 48 hours after surgery. After discharge, VAS was taken, also by the study subjects, twice a day, in the morning and evening of Dayday 3 through Dayday 7. Subjects were asked to complete a short form questionnaire, Brief Pain Inventory, on day 1, day 2, and final visit (day 7-10) after surgery. Patient satisfaction of postsurgical analgesia was assessed at the final visit using a 5-grade categorical scale. The primary objective of the study was to evaluate the efficacy and safety of single intramuscular injection of SDE in an extended-release formulation, against placebo control, administrated pre-operatively in subjects scheduled to undergo elective hemorrhoidectomies.
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female >= 20 years of age at Screening
- •Scheduled to electively undergo 2 or 3-column excisional hemorrhoidectomy
- •American Society of Anesthesiology Physical Class 1 - 3
- •Adequate clinical lab values (values of potential clinical concern are detailed in Appendix) or, if abnormal, deemed not clinically significant per the Investigator.
- •Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires
排除标准
- •Body weight less than 40 kg.
- •Concurrent fissurectomy.
- •Subject is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at Baseline.
- •Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.
- •History of hypersensitivity or allergy to amide-type local anesthetics, opioid, or any ingredient of the medications administered in this study.
- •Subject has a resting respiratory rate less than 8 per minute and blood oxygen saturation less than 90 mmHg.
- •Use of any NSAIDs, selective COX-2 inhibitors, opioid, acetaminophen, selective serotonin reuptake inhibitors (SSRI), tricyclic antidepressants (TCA), gabapentin, or pregabalin within three days of surgery.
- •Chronic use of opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week before screening visit.
- •Use of any long-acting opioid medication within 3 days of surgery or any opioid medication within 24 hours of surgery.
- •Current painful physical condition or concurrent surgery requires analgesic treatment in the postoperative period.
- •Contraindication to epinephrine or any of the pain-control agents planned for postoperative use.
- •Administration of an investigational drug within the longer of 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration.
- •Any psychiatric disorder, psychological, medical, or laboratory condition that may interfere with study assessments or compliance.
- •Significant medical conditions or laboratory results that may indicate an increased vulnerability to study drugs and procedures, and thus expose the subject to an unreasonable risk as a result of participating in this clinical trial.
- •Any clinically significant event or condition may be uncovered during surgery.
- •History of abuse illicit drugs, prescription medicines or alcohol within the past 2 years.
- •Known history of anti-HIV antibody positive
- •Failure to pass drug and alcohol screen.
研究组 & 干预措施
SDE 150mg
Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml)
干预措施: Sebacoyl Dinalbuphine Ester (Drug)
placebo
Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL)
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Assessment Calculated as the Area Under the Curve of VAS Pain Intensity Scores Through 48 Hours After Surgery
时间窗: 1±0.1, 2±0.1, 3±0.1, 4±0.25, 8±0.5, 12±0.5, 16±0.5, 20±0.5, 24±1, 28±1, 32±2, 36±2, 40±2, 44±2, 48±2 h after the surgery
The primary outcome measure of this study is pain assessment (time-specific pain intensity) calculated as the area under the curve (AUC) of VAS pain intensity scores through 48 hours after surgery (AUC0-48). Pain intensity was measured with visual analog scale (VAS) and the assessment began right before the first use of analgesics, and at 1±0.1, 2±0.1, 3±0.1, 4±0.25, 8±0.5, 12±0.5, 16±0.5, 20±0.5, 24±1, 28±1, 32±2, 36±2, 40±2, 44±2, 48±2 hours after the operation.
次要结局
- Pain Assessment Measured With VAS During Day 3-7 in the Morning and Evening, as Well as During Special Events Such as Bowel Movements.(Day 3-7)
- Consumption of Ketorolac Via Intravenous Patient- Controlled Analgesia (IV PCA)(Day 1-2)
- Time From the End of Operation to the First PCA Ketorolac Dose(From the end of operation until the first PCA ketorolac dose used, assessed up to 48 hrs)
- Brief Pain Inventory (BPI)(Day 1, 2 and Day 7)
- Consumption of Oral Ketorolac (Day 3-7)(Day 3-7)
- Subject Satisfaction With Post-Surgical Analgesic Between Treatment Groups(Day 7)