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

Daewon Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Fever; Acute Upper Respiratory Infection

Treatments: Drug: Loxoprofen; Drug: Pelubiprofen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01779271

Plb CD 301 Version 3.10

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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183 participants in 2 patient groups

Pelubiprofen

Experimental group

Treatment:

Drug: Pelubiprofen

Loxoprofen

Active Comparator group

Treatment:

Drug: Loxoprofen