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Last Updated: October 15, 2019

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CLINICAL TRIALS PROFILE FOR LORATADINE

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Clinical Trials for Loratadine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00319995 Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095) (COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2006-03-01 This is a Phase 3, randomized, parallel-group, multicenter, double-dummy, double-blind study with a screening period. Subjects will receive one of the following three treatment groups for 15 days: loratadine 10 mg/montelukast 10 mg combination, pseudoephedrine 240 mg, or placebo. The primary objective of this study is to assess the efficacy of the combination of loratadine/montelukast, a once-daily tablet containing 10 mg loratadine and 10 mg montelukast, compared with placebo in subjects with seasonal allergic rhinitis (SAR) in relieving the symptom of nasal congestion. The safety profile of combined loratadine/montelukast relative to placebo and pseudoephedrine will also be evaluated.
NCT00423995 Effect of Loratadine/Montelukast Combination on Congestion in SAR Patients Exposed to Pollen in an EEU (Study P04822) Completed Merck Sharp & Dohme Corp. Phase 3 2006-11-01 This is study of LMC, phenylephrine, and placebo in subjects with SAR. There are three visits: At Visit 1, subjects will be evaluated for participation and, if they qualify, will attend Visit 2 for priming. At Visit 2, ragweed pollen will be fed continuously and dispensed into the environmental exposure unit to induce an allergic reaction. Pollen counts will be monitored and recorded. During the priming visit(s), subjects will be evaluated to determine if they qualify. If qualified, they will return for Visit 3, where ragweed pollen will be fed continuously and dispensed into the environmental exposure unit to induce an allergic reaction. Pollen counts will be monitored and recorded as in the Priming Session. Subjects will complete symptom evaluations and if qualified, they will receive study medication and remain in the environmental exposure unit where symptoms will be evaluated for 8 hours after dosing. PNIF will be evaluated only during the treatment session. Four nasal symptoms (rhinorrhea, nasal congestion, sneezing, and nasal itching) and three non-nasal symptoms (itching/burning eyes, tearing/watery eyes, and itching of ears/palate) will be evaluated. Adverse events will be collected throughout the study to assess safety and tolerability, and vital signs will be collected at Visit 1 and at the end of Visit 3.
NCT00524836 Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis Completed UCB Pharma Phase 3 2003-09-01 Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis.
NCT00525278 To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis Completed UCB Pharma Phase 3 2003-08-01 To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis
NCT00525382 Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria Completed UCB Pharma Phase 3 2003-08-01 Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria.
NCT00730912 Post Approval Pharmacokinetic Study of Loratadine in Japanese Pediatric and Adult Patients (Study P05539) Completed Merck Sharp & Dohme Corp. Phase 4 2008-06-01 This is a post marketing study to confirm the appropriate dose of loratadine in children by obtaining drug concentration data at multiple time points per child and adult patient, after the patient receives repeated administrations of the approved dose of loratadine.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Loratadine

Condition Name

Condition Name for Loratadine
Intervention Trials
Seasonal Allergic Rhinitis 7
Healthy 6
Rhinitis 5
Allergic Rhinitis 4
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Condition MeSH

Condition MeSH for Loratadine
Intervention Trials
Rhinitis 25
Rhinitis, Allergic 25
Rhinitis, Allergic, Seasonal 14
Rhinitis, Allergic, Perennial 7
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Clinical Trial Locations for Loratadine

Trials by Country

Trials by Country for Loratadine
Location Trials
United States 45
Canada 4
Germany 2
Brazil 2
China 2
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Trials by US State

Trials by US State for Loratadine
Location Trials
New Jersey 3
Texas 2
North Carolina 2
Michigan 2
Maryland 2
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Clinical Trial Progress for Loratadine

Clinical Trial Phase

Clinical Trial Phase for Loratadine
Clinical Trial Phase Trials
Phase 4 8
Phase 3 14
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Loratadine
Clinical Trial Phase Trials
Completed 33
Not yet recruiting 5
Recruiting 5
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Clinical Trial Sponsors for Loratadine

Sponsor Name

Sponsor Name for Loratadine
Sponsor Trials
Merck Sharp & Dohme Corp. 12
Bayer 6
Ranbaxy Laboratories Limited 4
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Sponsor Type

Sponsor Type for Loratadine
Sponsor Trials
Industry 38
Other 17
NIH 1
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