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

Acute Traumatic Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03874247
• Other study ID #: DW9801-302
• Status: Recruiting
• Phase: Phase 3
• Start date: February 25, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2019
• Source: Daewon Pharmaceutical Co., Ltd.
• Contact: MOON
• Phone: +82-2-2204-7094
• Email: moonyw[@]daewonpharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Traumatic Injury
• Wounds and Injuries

Intervention

Drug:
• pelubiprofen 45mg
bid for 3 days after meal
• pelubiprofen placebo
bid for 3 days after meal

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul	Seodaemun-gu

Sponsors (1)

Lead Sponsor	Collaborator
Daewon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SPID-D3	Sum of Pain Intensity Differences(100 mm pain VAS)	Day 3