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

This study has been completed.
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd. Identifier:
First received: January 21, 2013
Last updated: October 7, 2016
Last verified: October 2016
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
Drug: Pelubiprofen
Drug: Loxoprofen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

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 ] [ Designated as safety issue: No ]

Enrollment: 183
Study Start Date: January 2013
Primary Completion Date: March 2016 (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


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01779271

Korea, Republic of
Chung-Ang University Hospital, South Korea
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewon Pharmaceutical Co., Ltd.
  More Information

Responsible Party: Daewon Pharmaceutical Co., Ltd. Identifier: NCT01779271     History of Changes
Other Study ID Numbers: Plb CD 301 Version 3.10 
Study First Received: January 21, 2013
Last Updated: October 7, 2016
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Daewon Pharmaceutical Co., Ltd.:

Additional relevant MeSH terms:
Respiratory Tract Infections
Respiratory Tract Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on October 26, 2016