A single dose observational study to assess the local tolerability of Diclofenac AQ Injection (Diclofenac Sodium 75 mg/ml injection manufactured by Akums Drugs and Pharmaceuticals Ltd., India.)
Phase 4
Recruiting
- Conditions
- Health Condition 1: M968- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified
- Registration Number
- CTRI/2021/01/030262
- Lead Sponsor
- Akums Drugs and Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients having severe inflammatory or spasmodic pain with VAS score up to 7 (mild to moderate pain) and requiring immediate relief.
2. Patients who are able to and willing to provide written informed consent
Exclusion Criteria
1. Hypersensitivity to the drug components or other drug from same class
2. Patient unable to refrain from alcohol, psychoactive drugs, and sedatives including sleeping preparations (eg benzodiazepines) for the duration of their participation in the study
3. Patient with history of drug of abuse
4. Patients recently diagnosed any viral or bacterial infection
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the local tolerability of Diclofenac AQ Injection (Diclofenac Sodium 75 mg/ml injection manufactured by Akums Drugs and Pharmaceuticals Ltd., India) upon intramuscular administration in patients having severe inflammatory or spasmodic painTimepoint: 24 hours post injection
- Secondary Outcome Measures
Name Time Method To monitor the adverse events. <br/ ><br>Global assessment by patient at the end of study <br/ ><br>Global assessment by physician at the end of study <br/ ><br>Timepoint: 24 hrs