Back to resultsPhase 3 Study of Pelubiprofen & Loxoprofen in Patients With Upper Respiratory Tract Infection
Primary Purpose
Acute Upper Respiratory Infection, Fever
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pelubiprofen
Loxoprofen
Sponsored by
About this trial
This is an interventional treatment trial for Acute Upper Respiratory Infection focused on measuring Pelubi, Pelubiprofen, Loxoprofen, Anti-pyretic, Fever
Eligibility 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
- Patients with Ulcers, gastrointestinal disorders which are confirmed by endoscopy
- Patients 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
Sites / Locations
- Chung-Ang University Hospital, South Korea
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pelubiprofen
Loxoprofen
Arm Description
Outcomes
Primary Outcome Measures
Changes in Body temperature from baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT01779271
First Posted
January 21, 2013
Last Updated
October 7, 2016
Sponsor
Daewon Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01779271
Brief Title
Phase 3 Study of Pelubiprofen & Loxoprofen in Patients With Upper Respiratory Tract Infection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Upper Respiratory Infection, Fever
Keywords
Pelubi, Pelubiprofen, Loxoprofen, Anti-pyretic, Fever
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
183 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pelubiprofen
Arm Type
Experimental
Arm Title
Loxoprofen
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pelubiprofen
Other Intervention Name(s)
Pelubiprofen 30 mg
Intervention Type
Drug
Intervention Name(s)
Loxoprofen
Other Intervention Name(s)
Loxoprofen 60mg
Primary Outcome Measure Information:
Title
Changes in Body temperature from baseline
Time Frame
0, 0.5, 1, 1.5, 2, 3, 4, 6 Hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Patients with Ulcers, gastrointestinal disorders which are confirmed by endoscopy
Patients 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
Facility Information:
Facility Name
Chung-Ang University Hospital, South Korea
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Phase 3 Study of Pelubiprofen & Loxoprofen in Patients With Upper Respiratory Tract Infection
We'll reach out to this number within 24 hrs