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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 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 10, 2014
Last verified: February 2014
  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:


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 2014 (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:

  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. Patinets with Ulcers, gastrointestinal disorders which are confirmed by endoscopy
  4. Patinets 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 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 10, 2014
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:
Communicable Diseases
Infection
Respiratory Tract Infections
Respiratory Tract Diseases
Loxoprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014