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

Phase 3

Completed

• Conditions: Acute Upper Respiratory Infection; Fever
• Interventions: Drug: Pelubiprofen; Drug: Loxoprofen

• Registration Number: NCT01779271
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

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 available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-21
• Study First Submitted QC: 2013-01-27
• Study First Posted: 2013-01-30
• Primary Completion: 2016-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-07
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelubiprofen	Pelubiprofen	-
Loxoprofen	Loxoprofen	-

Primary Outcome Measures

Name	Time	Method
Changes in Body temperature from baseline	0, 0.5, 1, 1.5, 2, 3, 4, 6 Hour

Trial Locations

Locations (1)

Chung-Ang University Hospital, South Korea; 🇰🇷 Seoul, Korea, Republic of