NCT03421054已完成不适用
Pilot, Open Non-controled Trial to Assess the Feasibility of Implementing Objective Parameters as Primary Endpoints in a Clinical Trial With Patients Affected by Knee Osteoarthritis
River Pharma S.r.l.1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2018年3月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- synovial effusion reduction
研究概览
简要总结
Pilot, open non-controlled trial to assess the feasibility of implementing objective parameters as primary endpoints in a clinical trial with patients affected by knee osteoarthritis.
详细描述
• to assess the feasibility of implementing ultrasonography and Range of motion (ROM) as objective measurements to correlate the improvement of the knee mobility with the pain reduction of the affected knee in the patients assuming nutraceutical containing HA.
The secondary objectives of the trial are:
- to assess the feasibility of implementing Actigraphy as objective measurements to correlate the improvement of the knee mobility with the pain reduction (optional).
- to evaluate the enrollment range in one month.
The explorative objectives of the trial are:
• Preliminary data on efficacy of the tested product
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender and age from 50 to 70 years
- •Symptomatic osteoarthritis (OA) of the knee with mild joint discomfort for at least 6 months prior to enrollment, following ACR criteria with history and physical examination (1). Subjects diagnosed with bilateral knee OA will be asked to specify the most affected knee at baseline, and this knee will be evaluated throughout the study period.
- •Available confirmatory X-ray (performed within the previous 6 months) diagnosis (Kellgren/Lawrence score 2) at the evaluated knee joint (2).
- •Subjects experienced pain for at least 15 of the 30 days prior to the start of the study.
排除标准
- •Subjects who have any inflammatory arthritic condition (different from the OA of the knee), fibromyalgia, multiple sclerosis or autoimmune disorder.
- •Treatment with oral corticosteroids within 4 weeks before screening.
- •Intra-articular injections of HA or corticosteroids in the target joint within 3 months before screening.
- •Treatment with anti-inflammatory or chondroprotective drugs (chondroitin sulfate, glucosamine, methylsulfonylmethane, HA, diacerein) 2 weeks before the selection.
- •HA-containing nutritional supplements or cosmetics during the month before the study.
- •Previous surgical treatment of knee joint(s) or its necessity; complication(s) necessary for hospitalization and surgical treatment.
- •Significant injury to the target joint within the past 6 months prior to screening (identified from medical history).
- •Subjects following an energy-restricted diet for weight loss.
- •Pregnant women, nursing mothers, or women (only if childbearing potential) not using adequate methods of contraception.
- •Subjects with cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
- •Participation in an interventional clinical study in the previous 30 days.
- •Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study.
研究组 & 干预措施
nutraceutical containing HA
Other
pain reduction of the affected knee in the patients assuming nutraceutical containing HA
干预措施: patients assuming nutraceutical containing HA (Dietary Supplement)
结局指标
主要结局
synovial effusion reduction
时间窗: week 4 and 8
Correlation between reduction in VAS (at rest) and ultrasonography parameters
次要结局
- pain reduction(week 4 and 8)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Allogenic Adipose-derived Mesenchymal Stem Cells(AMSCs) for Epilepsy During Deep Brain Stimulation(DBS) SurgeryEpilepsyNCT06280092Mayo Clinic1
已完成
1 期
Safety and Pharmacokinetics of KBPA-101 in Hospital Acquired Pneumonia Caused by O11 Pseudomonas AeruginosaVentilator Associated PneumoniaPneumoniaNCT00851435Kenta Biotech Ltd15
招募中
不适用
Examining the efficacy of a sleep-wake management tool for shift workersshift work disordersleep disorderdepressionstressanxietypoor cognitive performanceMental Health - Studies of normal psychology, cognitive function and behaviourinsomniaACTRN12622000836730Defence, Science and Technology Group (DSTG)40
已完成
3 期
A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG)Myasthenia GravisNCT02774239University of Alberta26
已完成
不适用
A Pilot Study of patients with Oligometastases from Prostate cancer treated with Stereotactic Ablative Body RadiosurgeryMetastatic Prostate Cancer (oligometastatic 1-3 metastases)Cancer - ProstateACTRN12613000436774Peter MacCallum Cancer Centre30