NCT06977568终止2 期
A Phase 2, Randomized, Open-Label, Two-Arm Study to Evaluate a Procedure for Intra-Articular Injection of ZILRETTA Versus Triamcinolone Acetonide, Immediate Release (TCA-IR) in Subjects With Osteoarthritis of the Hip
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Assessment of Successful Hip injection Rate
研究概览
简要总结
The goal of this clinical trial is to evaluate an injection procedure for the investigational drug in people with Osteoarthritis of the Hip. The Sponsor is conducting this research to evaluate successful injections in the hip by using two different needle sizes.
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
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1A: ZILRETTA and 20G Needle
Experimental
32mg ZILRETTA and 20-G Spinal Needle
干预措施: Zilretta (Drug)
2A TCA-IR and 20G Needle
Active Comparator
40mg TCA-IR and 20G Spinal Needle
干预措施: Triamcinolone Acetonide (Drug)
2B TCA-IR and 22G Needle
Active Comparator
40mg TCA-IR and 22G Needle
干预措施: Triamcinolone Acetonide (Drug)
1B ZILRETTA and 22G Needle
Experimental
32mg ZILRETTA and 22-G Spinal Needle
干预措施: Zilretta (Drug)
结局指标
主要结局
Assessment of Successful Hip injection Rate
时间窗: Day 1
The assessment of successful hip injection rate (injection of the full dose) for ZILRETTA and TCA-IR based on the 2 different needle-gauges
次要结局
- TEAE, AESIs, SAEs(From Day 1 through Week 12)
- Change in 24-hour average pain score(Change from Baseline to Week 1, Week 4, Week 8, and Week 12)
- Change in HOOS Survey(Change from Baseline to Week 1, Week 4, Week 8, and Week 12)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Phase 2, Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian (Study 38826)(P06055)(COMPLETED)FertilizationNCT00598208Organon and Co325
招募中
2 期
Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line TherapyMetastatic Colorectal CancerNCT05962502Sun Yat-sen University54
撤回
2 期
A Study to Assess Efficacy and Safety of Oral Tazemetostat in Adult Participants With Relapsed/Refractory Follicular Lymphoma That Does Not Have an "EZH2 Gain-of-function" Genetic MutationRefractory Follicular LymphomaFollicular LymphomaNCT06068881Epizyme, Inc.55
已完成
2 期
A Phase 2 Study to Evaluate Pharmacokinetics, Safety and Efficacy of TMC114/Ritonavir (Rtv) in Human Immunodeficiency Virus (HIV)-1 Infected Children and AdolescentsHIV-1HIV InfectionsNCT00355524Tibotec Pharmaceuticals, Ireland80
已完成
2 期
Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank AdipositySubcutaneous Fat DisorderNCT0576024810xBio, LLC13