Health Condition 1: M254- Effusion of joint
Conditions
Interventions
Intervention1: Triamcinolone Hexacetonide: Injectable Suspension 20 mg/ml will be administered on day 0 i.e. on enrollment visit of the study intraarticularly/periarticular in the target joint.
Pati
Sponsors
Abbott Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 investigatorâ??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
Exclusion criteria
Exclusion criteria: 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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number & proportion of patients with treatment-emergent adverse events (TEAEs) from baseline to end of the study Week 12.Timepoint: Baseline to weeks 1 4 8 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 b. reduction in severity & duration (minutes) of stiffness c. patient & investigator global assessment of disease activity 2. To evaluate the proportion of patients who take rescue medication tablets (Paracetamol 500 mg) for target local pain & mean number of rescue medication tablets (Paracetamol 500 mg) takenwhere THA was administered, from baselines to 12 th week i.e. end of the study.Timepoint: Baseline to weeks 1 4 8 12 | — |
Countries
India
Contacts
Public ContactDr Shivani Acharya
Abbott Healthcare Private Limited
Outcome results
None listed