Health Condition 1: T799- Unspecified early complication oftrauma
Conditions
Interventions
None listed
Sponsors
Abbott India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged >=18 years 2. Inpatients or outpatients presenting with acute traumatic pain of moderate intensity defined as VAS score >=6 cm 3. Patients who have been prescribed nefopam hydrochloride tablets as per local label 4. Patients willing to comply with study procedure and able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients taking any other analgesics within the period of up to 7 days prior to baseline 2. Pregnant and lactating women 3. Patients with cognitive impairment, alcohol abuse, or psychiatric illness that would affect the ability of the patient to complete patient diary and other assessments 4. Any other illness or conditions that does not justify patientâ??s participation in the study as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in pain intensity from baseline at 24 hours using a 10-cm VAS scaleTimepoint: Mean change in pain intensity from baseline at 24 hours using a 10-cm VAS scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and percentage of patients with treatment-emergent and treatment-related ADRs by system organ class and preferred term, and further classified by severity using the Common Terminology Criteria for Adverse Events (CTCAE)Timepoint: end of study | — |
Countries
India
Contacts
Public ContactSneha Nair
Abbott India Ltd
Outcome results
None listed