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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
NCT01779271 |
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Date of registration:
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21/01/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase 3 Study of Pelubiprofen & Loxoprofen in Patients With Upper Respiratory Tract Infection
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Scientific title:
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Date of first enrolment:
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January 2013 |
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Target sample size:
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183 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01779271 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Korea, Republic of
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Key inclusion & exclusion criteria
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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
Age minimum:
15 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Upper Respiratory Infection
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Fever
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Intervention(s)
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Drug: Pelubiprofen
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Drug: Loxoprofen
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Primary Outcome(s)
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Changes in Body temperature from baseline
[Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6 Hour]
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Secondary ID(s)
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Plb CD 301 Version 3.10
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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