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 - NA

Abbott Healthcare Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年12月19日

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•A patient must fulfill all the following criteria for inclusion in this study:
•1. Adolescent and adult patients aged = 13 years.
•2. Patients with subacute and chronic inflammation of a joint requiring treatment with the use of intraarticular/intra-synovial/periarticularsteroids based on investigator’s discretion.
•3. Patients with pain intensity with a VAS score = 45 mm at screening and baseline.
•4. Patients willing to comply with the study procedures and requirements
•5. Patients/parents/legal guardians or representatives/caregivers who are able to read,understand, and are willing to sign and date the informed consent form.
•6. Patients/parents/legal guardians or representatives/caregivers are willing to fill the
•patient diary and comply with the study procedure and requirements

•A patient will not be included in the study if they meet any of the exclusion criteria listed
•1. Significant (requiring surgical correction) deformity of the target joint.
•2. Concomitant inflammatory or any other disease/condition which may affect joints (e.g. metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis, etc.).
•3. 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).
•4. Clinically apparent tense effusion at the target joint
•5. Skin disease or infection in the area of the injection site.
•6. Arthrocentesis in the past 3 months.
•7. Allergic to the study drug or any of the other ingredients.
•8. Participation in any other clinical study in the past 30 days.
•9. Patients who had received intraarticular and/or periarticular systemic steroids in the previous 3 months.
•10. Any contra-indication to intraarticular and/or periarticular injection.
•11. Females with child-bearing potential who are pregnant or planning to become pregnant or are not ready to use contraceptive measures or are lactating
•12. Patients with any other disease/comorbidities which may be exacerbated with THA administration as per Investigators discretion

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