NCT03874247
Unknown
Phase 3
A Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury
ConditionsAcute Traumatic Injury
Overview
- Phase
- Phase 3
- Intervention
- pelubiprofen 45mg
- Conditions
- Acute Traumatic Injury
- Sponsor
- Daewon Pharmaceutical Co., Ltd.
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- SPID-D3
- Last Updated
- 7 years ago
Overview
Brief Summary
A randomized, double-blind, placebo-controlled, parallel, multi-center phase III clinical trial
Investigators
Eligibility Criteria
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
Arms & Interventions
Pelubiprofen
Intervention: pelubiprofen 45mg
Pelubiprofen placebo
Intervention: pelubiprofen placebo
Outcomes
Primary Outcomes
SPID-D3
Time Frame: Day 3
Sum of Pain Intensity Differences(100 mm pain VAS)
Study Sites (1)
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