NCT01779271

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

October 10, 2016

Status Verified

October 1, 2016

Enrollment Period

3.2 years

First QC Date

January 21, 2013

Last Update Submit

October 7, 2016

Conditions

Acute Upper Respiratory InfectionFever

Keywords

PelubiPelubiprofenLoxoprofenAnti-pyreticFever

Outcome Measures

Primary Outcomes (1)

  • Changes in Body temperature from baseline

    0, 0.5, 1, 1.5, 2, 3, 4, 6 Hour

Study Arms (2)

Pelubiprofen

EXPERIMENTAL
Drug: Pelubiprofen

Loxoprofen

ACTIVE COMPARATOR
Drug: Loxoprofen

Interventions

PelubiprofenDRUG
Also known as: Pelubiprofen 30 mg
Pelubiprofen
LoxoprofenDRUG
Also known as: Loxoprofen 60mg
Loxoprofen

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung-Ang University Hospital, South Korea

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 40094866DERIVED

MeSH Terms

Conditions

Fever

Interventions

pelubiprofenloxoprofen

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2013

First Posted

January 30, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2016

Last Updated

October 10, 2016

Record last verified: 2016-10

Locations

KR(1)