EUCTR2017-001028-23-FR进行中（未招募）1 期
Validation Study to Investigate the Effect of T4P1010 treatment in Patients with Osteoarthritic Pain of Knee or Hip.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 73
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Men or women of at least 18 years of age.
- •OA of knee or hip diagnosed since at least 6 months.
- •Pain scores reported during the baseline period preceding randomization
- •with a mean APS on the last 14 reported values before Visit 2 between 3.6 and 8.4 inclusive and to have completed at least 2/3 of each pain score in their diary between Visit 1 and Visit 2.
- •Patient with a unilateral or bilateral OA of the knee or hip diagnosed according to the American College of Rheumatology (ACR) criteria based on clinical and radiographic evidence (Altman et al., 1986) (in case of bilateral OA or OA of both knee and hip, the joint to consider should be the most affected one). The clinical diagnosis of OA will be confirmed by the ACR clinical criteria and medical imaging criteria for classification of OA of the knee or hip based upon the following criteria:
- •a. Knee or hip pain as an average at least half of the time for the last 3 months before screening visit.
- •b. OA of the knee, at least 1 of the following 3 conditions:
- •i. age > 50,
- •ii. morning stiffness <30 minutes,
- •iii. crepitus on active motion and osteophytes.
- •OA of the hip, at least 2 of the following 3 conditions:
- •i. erythrocyte sedimentation rate (ESR) < 20mm/hour,
- •ii. femoral and/or acetabular osteophytes,
- •iii. joint space narrowing (superior, axial, and/or medial).
- •c. Kellgren and Lawrence grade > 1 as assessed by a recent medical imaging of the referred joint to confirm the diagnosis. If no imaging available, a new anterior- posterior view will be obtained and reviewed by Investigator or his/her delegate(s) to verify that the patient meets the disease diagnostic criteria.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 38
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Change in the « regular analgesic therapy » or introduction of a « regular analgesic therapy » (if none beforehand) for OA in the last 4 weeks prior to Visit 1 or during the study.
- •Invariable pain scores reported between Visit 1 and Visit 2.
- •Pregnant, breastfeeding, or willing to be pregnant during the study.
- •Patients with a current or recent history, as determined by the Investigator, of
- •a. severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease;
- •b. any known hypersensitivity to corn and/or corn-derived products;
- •which would interfere with the patient's participation in the study.
- •Any other relevant medical disorder/acute disease state/pain condition like fibromyalgia, lombalgia, generalized OA judged by the Investigator as likely to interfere with the trial or represent a risk for the patient.
- •Having completed or withdrawn from this study or any study investigating T4P1001.
- •Have planned total knee or hip replacement intervention of the referred joint.
- •Reduced mobility due to OA (use of lower extremity assistive devices other than a cane or a knee sleeve such as crutches or walker or a knee brace or a shoe lift” in relation to OA is not allowed).
- •Use or plan to use systemic corticosteroids 4 weeks prior to Visit 1 or during the study; Intra-muscular corticosteroid injections or Intra-articular injection of steroids into the referred knee/hip within 3 months before Visit 1 or during the study; Intra-articular injection of corticosteroids into any other sites than the referred knee/hip within 4 weeks prior to Visit 1 or during the study (corticosteroids in topical use are allowed).
- •Have used viscosupplementation or intra articular injection of hyaluronic acid in the referred joint within 3 months prior to Visit 1 or plan to use during the study.
研究者
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