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

NCT ID: NCT03874247

Last Updated: 2019-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-25

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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Conditions

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Acute Traumatic Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind

Study Groups

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Pelubiprofen

Group Type EXPERIMENTAL

pelubiprofen 45mg

Intervention Type DRUG

bid for 3 days after meal

Pelubiprofen placebo

Group Type PLACEBO_COMPARATOR

pelubiprofen placebo

Intervention Type DRUG

bid for 3 days after meal

Interventions

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pelubiprofen 45mg

bid for 3 days after meal

Intervention Type DRUG

pelubiprofen placebo

bid for 3 days after meal

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, Seodaemun-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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MOON

Role: CONTACT

+82-2-2204-7094

Facility Contacts

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LEE, Ph.D.

Role: primary

Other Identifiers

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DW9801-302

Identifier Type: -

Identifier Source: org_study_id

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