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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01779271
First Posted: January 30, 2013
Last Update Posted: October 10, 2016
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.
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.
  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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

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 ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01779271


Locations
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.
ClinicalTrials.gov Identifier: NCT01779271     History of Changes
Other Study ID Numbers: Plb CD 301 Version 3.10
First Submitted: January 21, 2013
First Posted: January 30, 2013
Last Update Posted: October 10, 2016
Last Verified: October 2016

Keywords provided by Daewon Pharmaceutical Co., Ltd.:
Pelubi
Pelubiprofen
Loxoprofen
Anti-pyretic
Fever

Additional relevant MeSH terms:
Infection
Respiratory Tract Infections
Respiratory Tract Diseases
Loxoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents