Phase 3 Study of Pelubiprofen & Loxoprofen in Patients Wi... | NCT01779271

Studies
Phase 3 Study of Pelubiprofen & Loxoprofen in Patients With Upper Respiratory Tract Infection

NCT01779271

Sponsor

Daewon Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Oct 10, 2016Estimated

Enrollment

183Actual

Phase

Phase 3

Conditions

Acute Upper Respiratory Infection
Fever

Interventions

Pelubiprofen
Loxoprofen

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

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Mar 2016Actual

Completion Date

Not provided

First Submitted Date

Jan 21, 2013

First Submission Date that Met QC Criteria

Jan 27, 2013

First Posted Date

Jan 30, 2013Estimated

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

Oct 7, 2016

Last Update Posted Date

Oct 10, 2016Estimated

Description Module

Brief Summary

Multi-center, Randomized, Double blind, Controlled Parallel-group Comparative Phase 3 Clinical trial to assess the efficacy and safety of Pelubiprofen Compared to Loxoprofen in patients with Acute upper respiratory infection.

Detailed Description

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

183Actual

Label	Type	Description	Intervention Names
Pelubiprofen	Experimental		Drug: Pelubiprofen
Loxoprofen	Active Comparator		Drug: Loxoprofen

Name	Type	Description	Arm Group Labels	Other Names
Pelubiprofen	Drug		Pelubiprofen	Pelubiprofen 30 mg
Loxoprofen

Measure	Description	Time Frame
Changes in Body temperature from baseline		0, 0.5, 1, 1.5, 2, 3, 4, 6 Hour

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 15 years old
Male and Female
Patients with fever over 38.0°C due to cold (acute upper respiratory tract infection)
Patients with upper respiratory tract infection outbreak within 2 days and who did not received drug administration
Subjects who voluntarily or legal guardian agreed with written consent

Exclusion Criteria:

Fever reducer administration Within 4 hours from the screening point
Any incidence of febrile crisis from the past six months
Patients with Ulcers, gastrointestinal disorders which are confirmed by endoscopy
Patients with continuously administrating gastrointestinal disorder related drug
Patients with severe blood damage
Severe hepatic impairment (ALT, AST value more than 2 times the upper limit of the normal range)
With severe renal impairment (serum creatinine value is more than 2 times the upper limit of the normal range)
Patients with severe left ventricular dysfunction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40094866	Derived	Jang AS, Kim SH, Lee SP, Na MJ, Yoo KH, Park CH, Park SY, Choi BW. The Efficacy and Safety of Pelubiprofen in the Treatment of Acute Upper Respiratory Tract Infection: A Multicenter, Randomized, Double-Blind, Non-Inferiority Phase III Clinical Trial Compared to Loxoprofen. J Clin Med. 2025 Feb 21;14(5):1450. doi: 10.3390/jcm14051450.

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C040375	pelubiprofen
C040656	loxoprofen