This ClinicalStudy will be conducted to Evaluate the Safety & Effectiveness ofTriamcinolone Hexacetonide Injectable Suspension 20 mg/mlin Symptomatic Treatment of Subacute or Chronic JointInflammation in Indian Patients
- Conditions
- Effusion of joint,
- Registration Number
- CTRI/2023/07/055428
- Lead Sponsor
- Abbott Healthcare Private Limited
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
- A patient must fulfill all the following criteria for inclusion in this study: 1.
- 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 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.
- 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 below: 1.
- 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 5.
- 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 12.
- Patients with any other disease/comorbidities which may be exacerbated with THA administration as per Investigators discretion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number & proportion of patients with treatment-emergent adverse events (TEAEs) from baseline to end of the study Week 12. Baseline to weeks 1 4 8 12
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (7)
Aartham Multispeciality Hospital
🇮🇳Ahmadabad, GUJARAT, India
BGS Global Institute of Medical Sciences
🇮🇳Bangalore, KARNATAKA, India
GMERS medical college & civil hospital
🇮🇳Ahmadabad, GUJARAT, India
Government medical college & Government general hospital
🇮🇳Srikakulam, ANDHRA PRADESH, India
GSVM Medical college
🇮🇳Nagar, UTTAR PRADESH, India
Medical College Kolkata
🇮🇳Kolkata, WEST BENGAL, India
SRM Hospital
🇮🇳Chennai, TAMIL NADU, India
Aartham Multispeciality Hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Saurabh ShahPrincipal investigator9825243947drsnshah_13@yahoo.co.in