Effect of etoricoxib injection in acute pai

Phase 4

• Conditions: Health Condition 1: R52- Pain, unspecified

• Registration Number: CTRI/2022/12/048441
• Lead Sponsor: Zydus Healthcare Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in pain intensity score at 1 hourTimepoint: 1 hr

Secondary Outcome Measures

Name	Time	Method
Change from baseline in pain intensity score at other timepoints <br/ ><br>Time to onset of analgesia <br/ ><br>Clinically meaningful pain relief <br/ ><br>Use of rescue analgesic <br/ ><br>Number of Patients requiring additional analgesic at the end of 12 hours. <br/ ><br>Patientâ??s and investigatorâ??s global assessment of overall treatment efficacyTimepoint: 5 mins, 15mins, 30 mins, 45 mins, 4 hr, 8 hr, 12 hr