NCT01406561已完成3 期
A Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- KOOS Symptoms Subscale
研究概览
简要总结
The purpose of this study is to assess the effect of OMS103HP solution for Injection (OMS103HP-S) and function as measured by the Knee Osteoarthritis Outcome Survey (KOOS) Symptoms subscale through Day 30 compared with vehicle irrigation solution for knee symptoms in subjects undergoing meniscectomy.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily provide written informed consent in accordance with governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements, local regulations, and Health Insurance Portability and Accountability Act (HIPAA) Authorization (or equivalent if locally applicable)
- •In the opinion of the Investigator are able to comply with study-required visits and procedures
- •18 to 75 years of age, inclusive at the time of screening
- •Have a traumatic or degenerative meniscal cartilage injury (full thickness tear) that occurred at least 14 days prior to the day of arthroscopic surgery that is demonstrated on MRI
- •Planning to undergo unilateral arthroscopic meniscectomy
- •If female and of childbearing potential (i.e., not surgically sterilized or post-menopausal for longer than one year), agree to use a medically accepted method of birth control for the duration of her study involvement
- •At minimal risk from anesthesia and classified according to the American Society of Anesthesiologists Physical Status Classification as either PS-1 (a normal healthy patient) or PS-2 (a patient with mild systemic disease that results in no functional limitation) as determined by the Investigator.
排除标准
- •Significant arthritis in the surgical knee (Grade 3 or 4 on the Kellgren- Lawrence Grading Scale).
- •History of reactive synovial disease
- •History of a complex regional pain syndrome (Type I, i.e., reflex sympathetic dystrophy, or Type II, i.e., causalgia), chronic pain, attendance at a chronic pain clinic, or neurologic disorder associated with sensory deficit of the lower extremities
- •History of fibromyalgia
- •Expected to undergo any of the following procedures concurrent with the meniscectomy:
- •Meniscal repair procedure
- •Patellar tendon debridement
- •Patellar realignment
- •Lateral or retinacular release
- •Excision synovectomy (minor synovectomy to improve arthroscopic visualization is allowed)
- •Concurrent ligamentous procedure
- •Abrasion chondroplasty involving bone
- •Microfracture
- •Chondral transplantation
- •Use of more than three portals
- •Known allergies to any of the individual ingredients in OMS103HP-S, other NSAIDs, aspirin, tricyclic antidepressants, or opioid analgesics
- •Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
- •Have a job-related claim(s) under dispute or mediation
- •History of drug or alcohol abuse
- •Treatment with an investigational drug or device within 30 days prior to the day of surgery
- •A clinically significant medical condition that in the opinion of the Investigator would put the subject at increased risk, impair the subject's ability to comply with the requirements of the protocol, or confound the interpretation of the data
- •Expected to receive a regional block for analgesia for this procedure
- •Considered by the Investigator for any reason to be an unsuitable candidate for receipt of an investigational drug
- •The Investigator, employee of the investigative site, and/or part of the Investigator/employee's immediate families (defined as current spouse or partner, parent, natural or legally adopted child, stepchild living in the household, grandparent, or grandchild).
研究组 & 干预措施
OMS103HP-S
Experimental
OMS103HP-S injected into vehicle irrigation solution for administration during meniscectomy surgery
干预措施: OMS103HP-S (Drug)
Vehicle Irrigation Solution
Placebo Comparator
Vehicle Irrigation Solution
干预措施: Vehicle (Drug)
结局指标
主要结局
KOOS Symptoms Subscale
时间窗: 30 days
To evaluate the effect of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on knee symptoms as measured by the KOOS Symptoms subscale through Day 30.
Safety
时间窗: 90 days
To evaluate the safety of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on safety as measured by adverse events.
次要结局
- Knee Function in Sport Active patients(30 Days)
- Knee Pain(30 days)
- Knee Function(30 days)
- Quality of Life(30 days)
- Postoperative Knee Pain(Day of Surgery (day 1))
- Passive Flexion(7 Days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Double-Blind, Multicenter, Study Comparing the Efficacy and Safety of OMS103HP With Vehicle Irrigation Solution in Subjects Undergoing MeniscectomyPostoperative PainNCT00624845Omeros Corporation200
进行中（未招募）
3 期
A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)Diabetic Macular EdemaNCT06172257Oculis401
已完成
1 期
Exploratory Study of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction by Phacoemulsification.Cataract ExtractionNCT00721695Omeros Corporation60
已完成
2 期
A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)Diabetic Macular EdemaNCT05066997Oculis552
已完成
3 期
An Effectiveness, Safety and Quality of Life Measures With Hydromorphone HCL, Dilaudid CR (Controlled Release)Osteoarthritis, HipOsteoarthritis, KneeNCT00399048Alza Corporation, DE, USA140