Clinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury

Daewon Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Acute Traumatic Injury

Treatments: Drug: pelubiprofen placebo; Drug: pelubiprofen 45mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03874247

DW9801-302

Details and patient eligibility

About

A randomized, double-blind, placebo-controlled, parallel, multi-center phase III clinical trial

Enrollment: 94 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient, ages over 19 years
• Patients with post traumatic acute pain within 48 hr(sprain/strain)
• Patient whose pain scale is over 50 mm(VAS score)

Exclusion criteria

• Patients with chronic pain
• Presence of a fracture or more than one injury
• Previous adverse reaction or known allergy to NSAIDs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups, including a placebo group

Pelubiprofen

Experimental group

Treatment:

Drug: pelubiprofen 45mg

Pelubiprofen placebo

Placebo Comparator group

Treatment:

Drug: pelubiprofen placebo