CTRI/2025/01/079095Active, not recruitingUnknown
A Prospective, Open-label, Non-Comparative, Non-interventional, Multi-center, Active Post Marketing Surveillance (PMS) study to Assess the safety and tolerability of Diclofenac sodium 75mg/ml Injection manufactured by Themis Medicare Ltd, in patients with acute painful conditions
Themis Medicare Ltd.5 sites in 1 country200 target enrollmentStarted: February 1, 2025Last updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 5
- Primary Endpoint
- 1. Number of adverse events during the study period
Study Overview
Brief Summary
This is a prospective, Open-label, Non-Comparative, Non-interventional, Multi-center, Active Post Marketing Surveillance (PMS) study under a structured protocol to monitor and assess safety of Diclofenac sodium 75mg/ml Injection during the real-world usage. All treatment and monitoring of the patients will be done at the discretion of the treating physician (Investigator). The study will include 200 subjects including male & female patients of greater than or equal to 18 years of age with acute painful conditions in post operative conditions.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male and female patients of greater than or equal to 18 years of age
- •Patients requiring diclofenac injection for management of painful conditions in post-operative condition
- •Patients/LAR who agree to give informed consent.
Exclusion Criteria
- •Any of the contraindications to use of the study investigational product, as per the Prescribing Information a.
- •Known hypersensitivity to the active substance or to any of the excipients b.
- •Active gastric or intestinal ulcer, bleeding or perforation c.
- •Last trimester of pregnancy d.
- •History of severe hepatic, renal or cardiac failure e.
- •Patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs f.
- •Haemostasias disorders or current anticoagulant treatment (for intramuscular route of administration only) g.
- •Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease Specifically, for I.V. use h.
- •Concomitant NSAID or anticoagulant use (including low dose heparin).
- •History of hemorrhagic diathesis, a history of confirmed or suspected cerebrovascular bleeding j.
- •Operations associated with a high risk of hemorrhage k.
- •A history of asthma l.
- •Moderate or severe renal impairment (serum creatinine greater than 160 µmol/L) m.
- •Hypovolemia or dehydration from any cause
- •A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.
Outcomes
Primary Outcomes
1. Number of adverse events during the study period
Time Frame: 1. Number of adverse events from baseline (Day 1) to End of study (Day 3).
Secondary Outcomes
- 1. Number of SAEs during the study period.(2. Incidence of all SAEs unrelated/related to study drug during the study.)
Investigators
Dr Ambanna Gowda
Citizen Hospital
Study Sites (5)
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