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.)

A multicentric, open labelled, non-comparative, single dose observational study to assess the local tolerability of Diclofenac AQ Injection(DiclofenacSodium 75 mg/ml injection manufactured by Akums Drugs and Pharmaceuticals Ltd., India.) upon Intramuscular administration in patients having severe inflammatory or spasmodic pain

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/01/030262

Enrollment

500

Registered

2021-01-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M968- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified

Interventions

None listed

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To monitor the adverse events. Global assessment by patient at the end of study Global assessment by physician at the end of study Timepoint: 24 hrs	—

Countries

India

Contacts

Public ContactMamta Sharma

CRO PHARMATRENDZ PRIVATE LIMITED

drsai@pharmatrendz.com9861252518

Outcome results