Health Condition 1: M255- Pain in joint
Conditions
Interventions
Intervention1: Diclofenac Sodium 75 gm/ml Injection: Diclofenac Sodium BP........... 75 mg
Benzyl Alcohol BP????2% v/v
Water for Injections BP???..Q.S.
Intervention2: Diclofenac 75mg/ml Injection (1 m
Sponsors
Themis Medicare Ltd.
Clinical Research Network India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients of greater than or equal to 18 years of age 2. Patients requiring diclofenac injection for management of painful conditions in post-operative condition 3. Patients/LAR who agree to give informed consent
Exclusion criteria
Exclusion criteria: 1. 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). i. 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 ?mol/L) m. Hypovolemia or dehydration from any cause 2. A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of adverse events during the study periodTimepoint: 1. Number of adverse events from baseline (Day 1) to End of study (Day 3). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of SAEs during the study period. 2. Incidence of all SAEs unrelated/related to study drug during the study. 3. Incidence of all Adverse Drug Reactions (AEs related to study drug) during the study. 4. Incidence of Injection Site Reaction (ISR) during the study. 5. Incidence of any Adverse Drug Reactions referring to renal toxicity during the study. 6. Overall Efficacy of study drug (Change in Pain from baseline to end of study as assessed on 100mm VAS scale.) 7. Overall Tolerability reported by physician at the end of the study.Timepoint: Safety will be assessed from baseline (Day 1) to End of study (Day 3). | — |
Countries
India
Contacts
Public ContactDr Balaji More
Themis Medicare Ltd.
Outcome results
None listed