Health Condition 1: R52- Pain, unspecified
Conditions
Interventions
Intervention1: Injection Etoricoxib: 90mg/ml intramuscular injection once daily (single dose)
Control Intervention1: Injection Diclofenac sodium: 75mg/ml intramuscular injection once daily (single dos
Sponsors
Zydus Healthcare Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult subjects (Males & Females) 18-65 years (both inclusive) 2. Adult subjects with Acute Musculoskeletal pain VAS score >= 5 at baseline. 3. Subject willing to comply study procedure. 4. Subject willing to sign ICF
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug. 2. Patients already on any NSAIDs. 3. History or presence of any disease or disorder known to influence bone metabolism, compromise the haematopoietic system, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, musculoskeletal or any other body system. 4. Pregnant & Lactating patients. 5. Patients with History of High Cardio vascular risk- (CAD, Heart failure, Unstable Angina). 6. High Hepatic risk patients (Cirrhosis & Liver failure). 7. High Renal risk patients (ARF,CRF, Dialysis). 8. Patients with history of high GI risks-( Bleeding, Perforation, Ulcers) 9. Patients with history of Bronchial Asthma, ARDS, COPD 10. Patients with diagnosed coagulation defects or patients on aspirin, anti-coagulants. 11. Mentally Retarded patients. 12. Participation in another clinical trial in the past 3 months 13. Patients with history of alcohol and/or drug abuse in past one year. 14. History of Positive HIV, VDRL/RPR, Hepatitis B and C tests. 15. Covid 19 patients. 16. Any other reason for which the investigator feels that the patient should not participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in pain intensity score at 1 hourTimepoint: 1 hr | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in pain intensity score at other timepoints Time to onset of analgesia Clinically meaningful pain relief Use of rescue analgesic Number of Patients requiring additional analgesic at the end of 12 hours. Patientâ??s and investigatorâ??s global assessment of overall treatment efficacyTimepoint: 5 mins, 15mins, 30 mins, 45 mins, 4 hr, 8 hr, 12 hr | — |
Countries
India
Contacts
Public ContactDr Yatin Desai
Zydus Hospital
Outcome results
None listed