Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients
NCT ID: NCT01640535
Last Updated: 2013-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
283 participants
INTERVENTIONAL
2012-06-30
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Test arm
Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg
Montelukast + Levocetirizine
Tablet, Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)
Comparator arm I
Matching placebo of Montelukast sodium 10mg + Levocetirizine dihydrochloride 5 mg
Levocetirizine
Tablet, Matching placebo of Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)
Comparator arm II
Montelukast sodium 10mg + matching placebo of Levocetirizine dihydrochloride 5mg
Montelukast
Tablet, Montelukast sodium 10 mg + matching placebo of Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)
Interventions
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Montelukast + Levocetirizine
Tablet, Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)
Levocetirizine
Tablet, Matching placebo of Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)
Montelukast
Tablet, Montelukast sodium 10 mg + matching placebo of Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive results of skin prick test
* Patients who provided a signed written informed consent form
* Patients who are able and willing to complete subject diaries
* Patients who agree to maintain consistency in their surroundings throughout the study period
* At Visit, 2 patients whose symptom scores recorded in the subject diary meet all of the followings during the last one week of baseline period A.Daily mean of 6 points or above for Daytime Nasal Symptom Score (maximum 12 points) B.Daily mean of 1.8 points or above for Daytime Nasal Obstruction Symptom Score (maximum 3 points)
Exclusion Criteria
* Patients with severe asthma who meet the followings.
* Presence of nasal polyps or any clinically important nasal anomaly.
* History of acute • chronic sinusitis within 30 days of Visit 1
* History of intranasal / eye surgeries within 3 months of Visit 1
* Initiation of immunotherapy or dose modification within 1 month prior to Visit 1
* Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 1.
* Chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug
* At Visit 2, patients who recorded Daytime Nasal Symptom Scores for fewer than 4 days in the subject diary during the last one week of baseline period
15 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Kyungmi PARK, PhD
Role: STUDY_DIRECTOR
Hanmi Pharmaceutical Company Limited
Locations
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Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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HM-MOLZ-301
Identifier Type: -
Identifier Source: org_study_id
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