CTRI/2023/07/055428已完成4 期
An Open-label, Single-arm, Multi-centric Phase IV ClinicalStudy to Evaluate the Safety & Effectiveness ofTriamcinolone Hexacetonide Injectable Suspension 20 mg/mlin Symptomatic Treatment of Subacute or Chronic JointInflammation in Indian Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Number & proportion of patients with treatment-emergent adverse events (TEAEs) from baseline to end of the study Week 12.
研究概览
简要总结
Its An Open-label, Single-arm, Multi-centric Phase IV Clinical Study to Evaluate the Safety and Effectiveness of Triamcinolone Hexacetonide Injectable Suspension 20 mg/ml in Symptomatic Treatment of Subacute or Chronic Joint Inflammation in approximately 200 Indian Patients from approximately 10 clinical sites. There are six visits in the study and study duration is of 336 days (48 weeks)
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 13.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •A patient must fulfill all the following criteria for inclusion in this study:
- •Adolescent and adult patients aged ≥ 13 years.
- •Patients with subacute and chronic inflammation of a joint requiring treatment with the use of intraarticular/intra-synovial/periarticularsteroids based on investigator’s discretion.
- •Patients willing to comply with the study procedures and requirements
- •Patients/parents/legal guardians or representatives/caregivers who are able to read,understand, and are willing to sign and date the informed consent form.
- •Patients/parents/legal guardians or representatives/caregivers are willing to fill the patient diary and comply with the study procedure and requirements.
排除标准
- •A patient will not be included in the study if they meet any of the exclusion criteria listed below:
- •Significant (requiring surgical correction) deformity of the target joint.
- •Concomitant inflammatory or any other disease/condition which may affect joints (e.g. metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis, etc.).
- •History of sepsis in the target joint or any clinical concern for acute or subacute infectious process in the target joint e.g. active tuberculosis, herpes simplex keratitis,systemic mycoses, and parasitoses (strongyloid infections).
- •Clinically apparent tense effusion at the target joint
- •Skin disease or infection in the area of the injection site.
- •Arthrocentesis in the past 3 months.
- •Allergic to the study drug or any of the other ingredients.
- •Participation in any other clinical study in the past 30 days.
- •Patients who had received intraarticular and/or periarticular systemic steroids in the previous 3 months.
- •Any contra-indication to intraarticular and/or periarticular injection.
- •Females with child-bearing potential who are pregnant or planning to become pregnant or are not ready to use contraceptive measures or are lactating
- •Patients with any other disease/comorbidities which may be exacerbated with THA administration as per Investigators discretion.
结局指标
主要结局
Number & proportion of patients with treatment-emergent adverse events (TEAEs) from baseline to end of the study Week 12.
时间窗: Baseline to weeks 1 4 8 12
次要结局
- 1. To evaluate the effectiveness of THA 20 mg/ml from administration to end of the study i.e. 12 weeks. in terms of:(a. reduction in pain intensity)
研究者
研究点 (7)
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