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

Sponsor

Daewon Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01779271

Collaborator

(none)

183

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Upper Respiratory Infection Fever	Drug: Pelubiprofen Drug: Loxoprofen	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

183 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pelubiprofen	Drug: Pelubiprofen Other Names: Pelubiprofen 30 mg
Active Comparator: Loxoprofen	Drug: Loxoprofen Other Names: Loxoprofen 60mg

Arm

Intervention/Treatment

Experimental: Pelubiprofen

Drug: Pelubiprofen

Other Names:

Pelubiprofen 30 mg

Active Comparator: Loxoprofen

Drug: Loxoprofen

Other Names:

Loxoprofen 60mg

Outcome Measures

Primary Outcome Measures

Changes in Body temperature from baseline [0, 0.5, 1, 1.5, 2, 3, 4, 6 Hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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