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Generated: November 19, 2017

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR
LORATADINE REDIDOSE

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Clinical Trial Listing

Trial ID Title Status Sponsor Phase Summary
NCT00319995 Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095) (COMPLETED)CompletedMerck Sharp & Dohme Corp.Phase 3 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)CompletedMerck Sharp & Dohme Corp.Phase 3 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 RhinitisCompletedUCB PharmaPhase 3 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 RhinitisCompletedUCB PharmaPhase 3 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 UrticariaCompletedUCB PharmaPhase 3 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)CompletedMerck Sharp & Dohme Corp.Phase 4 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.
NCT00762983 Observation of Use of Claritin (Loratadine) Tablet, RediTabs, and Dry Syrup in Children (Study P05834)(COMPLETED)CompletedMerck Sharp & Dohme Corp.N/A The purpose of this study is to collect information on unexpected adverse reactions (ADRs), how often ADRs occur, and factors that can affect the safety and effectiveness of Claritin (loratadine) when used in children. Patients will be observed while they are taking Claritin, and ADRs and symptom scores will be recorded. At the end of treatment, improvement in symptoms will be recorded. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
NCT00776217 Bioequivalence Study on Loratadine Orally Disintegrating Tablets 10 mg Under Fasting ConditionsCompletedRanbaxy Laboratories LimitedN/A To compare the single-dose oral bioavailability of loratadine 10 mg orally disintegrating tablets of Ohm Laboratories (a subsidiary of Ranbaxy Pharmaceuticals Inc., USA) with Claritin® Reditabs® (containing loratadine 10 mg) of Schering-Plough Healthcare Product Inc., USA in healthy, adult, human male subjects under fasting condition.
NCT00776282 Bioequivalence Study of Loratadine Orally Disintegrating Tablets 10 mg Under Fed ConditionsCompletedRanbaxy Laboratories LimitedN/A To compare the single-dose oral bioavailability of loratadine 10 mg orally disintegrating tablets of Ohm Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals, Inc. USA) with Claritin® Reditabs® (containing loratadine 10 mg) of Schering-Plough Healthcare Product Inc., USA in healthy, adult, human male subjects under fed condition.
NCT00796211 A Single-Center Exploratory Study to Assess the Activity of CRx-197-002 in Plaque PsoriasisCompletedZalicusPhase 2 This will be a phase 2a single-center, randomized, blinded, vehicle-controlled exploratory study to assess the activity and safety of CRx-197 in subjects with plaque psoriasis. Approximately 20 male or female subjects with chronic plaque type psoriasis, 18 to 70 years of age, will be included in this study. All subjects with stable psoriatic plaques will receive all of the following treatments each in a separate test field, once each day for four weeks under occlusion: - CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine) - CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine) - 0.1% nortriptyline HCl topical cream - 0.005% calcipotriol topical cream - Vehicle of CRx-197 topical cream (placebo)
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Conditions

Condition Name

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

Condition MeSH for LORATADINE REDIDOSE
Intervention Trials
Rhinitis 23
Rhinitis, Allergic 23
Rhinitis, Allergic, Seasonal 13
Rhinitis, Allergic, Perennial 7
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Trial Locations

Trials by Country

Trials by Country for LORATADINE REDIDOSE
Location Trials
United States 42
Canada 3
Germany 2
Brazil 2
China 2
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Trials by US State

Trials by US State for LORATADINE REDIDOSE
Location Trials
New York 2
Maryland 2
Texas 2
North Carolina 2
Florida 1
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Clinical Trial Progress

Clinical Trial Phase

Clinical Trial Phase for LORATADINE REDIDOSE
Clinical Trial Phase Trials
Phase 4 7
Phase 3 13
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for LORATADINE REDIDOSE
Clinical Trial Phase Trials
Completed 29
Recruiting 5
Not yet recruiting 4
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Clinical Trial Sponsors

Sponsor Name

Sponsor Name for LORATADINE REDIDOSE
Sponsor Trials
Merck Sharp & Dohme Corp. 11
Ranbaxy Laboratories Limited 4
Bayer 3
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Sponsor Type

Sponsor Type for LORATADINE REDIDOSE
Sponsor Trials
Industry 34
Other 16
NIH 1
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Serving leading biopharmaceutical companies globally:

Julphar
Queensland Health
Mallinckrodt
Daiichi Sankyo
Baxter
Farmers Insurance
Harvard Business School
QuintilesIMS
Medtronic
Deloitte

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