Clinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury
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
1 other identifier
interventional
94
1 country
1
Brief Summary
A randomized, double-blind, placebo-controlled, parallel, multi-center phase III clinical trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2019
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2019
CompletedFirst Submitted
Initial submission to the registry
March 12, 2019
CompletedFirst Posted
Study publicly available on registry
March 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedMarch 19, 2019
March 1, 2019
10 months
March 12, 2019
March 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
SPID-D3
Sum of Pain Intensity Differences(100 mm pain VAS)
Day 3
Study Arms (2)
Pelubiprofen
EXPERIMENTALPelubiprofen placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Patients with chronic pain
- Presence of a fracture or more than one injury
- Previous adverse reaction or known allergy to NSAIDs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, Seodaemun-gu, South Korea
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2019
First Posted
March 14, 2019
Study Start
February 25, 2019
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
March 19, 2019
Record last verified: 2019-03