Clinical Trial to Evaluate the Efficacy and Safety of 'Pe... | NCT03874247

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

NCT03874247

Sponsor

Daewon Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Mar 19, 2019Actual

Enrollment

94Estimated

Phase

Phase 3

Conditions

Acute Traumatic Injury

Interventions

pelubiprofen 45mg
pelubiprofen placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 25, 2019Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Mar 12, 2019

First Submission Date that Met QC Criteria

Mar 13, 2019

First Posted Date

Mar 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2019

Last Update Posted Date

Mar 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

94Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pelubiprofen	Experimental		Drug: pelubiprofen 45mg
Pelubiprofen placebo	Placebo Comparator		Drug: pelubiprofen placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pelubiprofen 45mg	Drug	bid for 3 days after meal	Pelubiprofen
pelubiprofen placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SPID-D3	Sum of Pain Intensity Differences(100 mm pain VAS)	Day 3

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
MOON	Contact	+82-2-2204-7094		moonyw@daewonpharm.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital	Recruiting	Seoul	Seodaemun-gu		South Korea

Intervention Browse Module

MeSH Terms

ID	Term
C040375	pelubiprofen

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided