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

Phase 3

• Conditions: Acute Traumatic Injury
• Interventions: Drug: pelubiprofen 45mg; Drug: pelubiprofen placebo

• Registration Number: NCT03874247
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-25
• Status Verified: 2019-03
• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-14
• Last Update Submitted: 2019-03-17
• Last Update Posted: 2019-03-19
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelubiprofen	pelubiprofen 45mg	-
Pelubiprofen placebo	pelubiprofen placebo	-

Primary Outcome Measures

Name	Time	Method
SPID-D3	Day 3	Sum of Pain Intensity Differences(100 mm pain VAS)

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Seodaemun-gu, Korea, Republic of