NCT02193620已完成2 期
A Randomized, Double Blind, Placebo-controlled, Multiple Dose Study to Assess the Efficacy, Safety and Pharmacokinetics of Oral Nalbuphine, an Oral Soft Capsule, for Post-hemorrhoidectomy Pain Management
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- the area under the curve of VAS pain intensity scores
研究概览
简要总结
The purpose of this study is to assess the effectiveness, safety and pharmacokinetics of Oral Nalbuphine in the treatment of postoperative pain following hemorrhoidectomy.
详细描述
• Primary Efficacy Endpoint: Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours.
• Secondary Efficacy Endpoints:
- Consumption of diclofenac (Day 1-2) via Intramuscular Injection (IM injection).
- Time from the end of operation to the first IM injection diclofenac dose
- Brief Pain Inventory (BPI).
- Patient satisfaction.
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
- •Clinical lab values twice the upper limit of normal (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, Intrauterine Device (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 Cyclooxygenase-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.
- •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 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
Study group
Experimental
PHN131 soft capsule with Nalbuphine Hydrogen chloride (HCl) 60 mg/cap
干预措施: PHN131 soft capsule with Nalbuphine HCl 60 mg/cap (Drug)
Placebo group
Placebo Comparator
Placebo soft capsules
干预措施: Placebo soft capsules (Drug)
结局指标
主要结局
the area under the curve of VAS pain intensity scores
时间窗: at 1, 2, 3, 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, and 48±2 h after the surgery
Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours
次要结局
- Brief Pain Inventory (BPI)(at 24h and 48h after surgery)
- Consumption of diclofenac dose(in 48 hours after surgery)
- Time of operation to diclofenac dose(in 48 hours after surgery)
- Patient satisfaction(at 48h after surgery)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
早期 1 期
Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating DisorderSleep-Related Eating DisorderNCT00606411Massachusetts General Hospital34
已完成
2 期
A Study Evaluating Effects of Intranasal JNJ-17166864 on Symptoms of Allergic Rhinitis in AdultsAllergic RhinitisNCT00604123Johnson & Johnson Pharmaceutical Research & Development, L.L.C.74
已完成
1 期
A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of JNJ-28431754 in Patients With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT01177163Johnson & Johnson Pharmaceutical Research & Development, L.L.C.29
终止
4 期
A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic DisorderPanic DisorderNCT00635531Pfizer's Upjohn has merged with Mylan to form Viatris Inc.16
已完成
2 期
Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic PruritusUremic PruritusPruritusNCT02143648Trevi Therapeutics373