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

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.

Study Overview

• Status: Completed
• Conditions: Fever; Acute Upper Respiratory Infection
• Intervention / Treatment: Drug: Pelubiprofen; Drug: Loxoprofen

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital, South Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in Body temperature from baseline	0, 0.5, 1, 1.5, 2, 3, 4, 6 Hour

Collaborators and Investigators

• Sponsor: Daewon Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion: December 6, 2022

Study Registration Dates

• First Submitted: January 21, 2013
• First Submitted That Met QC Criteria: January 27, 2013
• First Posted (Estimate): January 30, 2013

Study Record Updates

• Last Update Posted (Estimate): October 10, 2016
• Last Update Submitted That Met QC Criteria: October 7, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Pelubi; Pelubiprofen; Loxoprofen; Anti-pyretic; Fever
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infections; Respiratory Tract Infections; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Loxoprofen
• Other Study ID Numbers: Plb CD 301 Version 3.10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No