Back to resultsClinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury
Primary Purpose
Acute Traumatic Injury
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pelubiprofen 45mg
pelubiprofen placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Traumatic Injury
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
Sites / Locations
- Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pelubiprofen
Pelubiprofen placebo
Arm Description
Outcomes
Primary Outcome Measures
SPID-D3
Sum of Pain Intensity Differences(100 mm pain VAS)
Secondary Outcome Measures
Full Information
NCT ID
NCT03874247
First Posted
March 12, 2019
Last Updated
March 17, 2019
Sponsor
Daewon Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03874247
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A randomized, double-blind, placebo-controlled, parallel, multi-center phase III clinical trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Traumatic Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pelubiprofen
Arm Type
Experimental
Arm Title
Pelubiprofen placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pelubiprofen 45mg
Intervention Description
bid for 3 days after meal
Intervention Type
Drug
Intervention Name(s)
pelubiprofen placebo
Intervention Description
bid for 3 days after meal
Primary Outcome Measure Information:
Title
SPID-D3
Description
Sum of Pain Intensity Differences(100 mm pain VAS)
Time Frame
Day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MOON
Phone
+82-2-2204-7094
Email
moonyw@daewonpharm.com
Facility Information:
Facility Name
Severance Hospital
City
Seoul
State/Province
Seodaemun-gu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LEE, Ph.D.
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury
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