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

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Upper Respiratory Infection Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pelubiprofen

Group Type EXPERIMENTAL

Pelubiprofen

Intervention Type DRUG

Loxoprofen

Group Type ACTIVE_COMPARATOR

Loxoprofen

Intervention Type DRUG

Interventions

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Pelubiprofen

Intervention Type DRUG

Loxoprofen

Intervention Type DRUG

Other Intervention Names

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Pelubiprofen 30 mg Loxoprofen 60mg

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No