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

This study is currently recruiting participants.

Verified January 2013 by Daewon Pharmaceutical Co., Ltd.

Sponsor:

Information provided by (Responsible Party):

Daewon Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01779271

First received: January 21, 2013

Last updated: February 19, 2013

Last verified: January 2013

History of Changes

Purpose

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	Intervention	Phase
Acute Upper Respiratory Infection Fever	Drug: Pelubiprofen Drug: Loxoprofen	Phase 3

Study Type:

Interventional

Resource links provided by NLM:

MedlinePlus related topics: Common Cold Fever

U.S. FDA Resources

Further study details as provided by Daewon Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

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

Study Start Date:	January 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pelubiprofen	Drug: Pelubiprofen Other Name: Pelubiprofen 30 mg
Active Comparator: Loxoprofen	Drug: Loxoprofen Other Name: Loxoprofen 60mg

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both

Criteria

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
Patinets with Ulcers, gastrointestinal disorders which are confirmed by endoscopy
Patinets 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779271

Locations

Korea, Republic of
Chung-Ang University Hospital, South Korea	Recruiting
Seoul, Korea, Republic of
Contact: Byung-Hui Choi, pf. +82 02-6299-2738

Sponsors and Collaborators

Daewon Pharmaceutical Co., Ltd.

More Information

No publications provided

Responsible Party:	Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01779271 History of Changes
Other Study ID Numbers:	Plb CD 301 Version 3.10
Study First Received:	January 21, 2013
Last Updated:	February 19, 2013
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Daewon Pharmaceutical Co., Ltd.:

Pelubi
Pelubiprofen
Loxoprofen
Anti-pyretic
Fever

Additional relevant MeSH terms:

Fever
Respiratory Tract Infections
Common Cold
Body Temperature Changes
Signs and Symptoms
Infection
Respiratory Tract Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Loxoprofen

Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013

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