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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01779271
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : October 10, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Upper Respiratory Infection Fever Drug: Pelubiprofen Drug: Loxoprofen Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2013
Actual Primary Completion Date : March 2016

Arm Intervention/treatment
Experimental: Pelubiprofen Drug: Pelubiprofen
Other Name: Pelubiprofen 30 mg

Active Comparator: Loxoprofen Drug: Loxoprofen
Other Name: Loxoprofen 60mg

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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01779271

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

Responsible Party: Daewon Pharmaceutical Co., Ltd. Identifier: NCT01779271     History of Changes
Other Study ID Numbers: Plb CD 301 Version 3.10
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016

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