DeepMed Research

Loratadine

Generic Name: Loratadine

Brand Names: Alavert, Alavert D, Allerclear, Claritin, Claritin-D, Diphen, Loradamed, Wal-itin, Wal-itin D

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₃ClN_₂O_₂

CAS Number: 79794-75-5

Unique Ingredient Identifier: 7AJO3BO7QN

Background: Loratadine is a second generation antihistamine used to manage symptoms of allergic rhinitis. A lack of sedative and CNS adverse effects make loratadine, along with other second generation antihistamines, preferable over their 1st generation counterparts in many clinical situations.

Indication: Loratadine is a 2nd generation antihistamine and is used to manage symptoms of allergic rhinitis, wheal formation, urticaria, and other allergic dermatologic conditions.

Associated Conditions: Allergic Dermatologic Disorders, Allergic Reaction, Allergic Rhinitis (AR), Allergy to Tree Pollen, Chronic Urticaria, Common Cold, Epiphora, Eye pruritus, Fever, Nasal Congestion, Nasal Itching, Pain, Perennial Allergic Rhinitis (PAR), Pruritus, Rhinitis Perennial, Rhinorrhoea, Seasonal Allergic Rhinitis, Sneezing, Sensation of burning in the eyes, Watery itchy eyes

Clinical Trials

To Demonstrate the Relative Bioavailability Study of Loratadine 10 mg Tablets

Phase 1

Completed

Conditions: Allergy

Interventions: Drug: Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)
Drug: Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)
Drug: Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)

First Posted Date: 2009-07-27

Last Posted Date: 2017-03-28

Lead Sponsor: Sandoz

Target Recruit Count: 30

Registration Number: NCT00946608

Bioequivalnce Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fasting Conditions

Not Applicable

Completed

Conditions: Healthy

Interventions: Drug: Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets

First Posted Date: 2009-02-06

Last Posted Date: 2009-02-06

Lead Sponsor: Ranbaxy Laboratories Limited

Target Recruit Count: 40

Registration Number: NCT00837915

Locations: 🇨🇦
MDS Pharma Services, Montreal, Quebec, Canada

Bioequivalence Study on Loratadine Orally Disintegrating Tablets 10 mg Under Fasting Conditions

Not Applicable

Completed

Conditions: Healthy

Interventions: Drug: loratadine 10 mg orally disintegrating tablets

First Posted Date: 2008-10-21

Last Posted Date: 2008-10-21

Lead Sponsor: Ranbaxy Laboratories Limited

Target Recruit Count: 80

Registration Number: NCT00776217

Bioequivalence Study of Loratadine Orally Disintegrating Tablets 10 mg Under Fed Conditions

Not Applicable

Completed

Conditions: Healthy

Interventions: Drug: loratadine 10 mg orally disintegrating

First Posted Date: 2008-10-21

Last Posted Date: 2008-10-21

Lead Sponsor: Ranbaxy Laboratories Limited

Target Recruit Count: 80

Registration Number: NCT00776282

Observation of Use of Claritin (Loratadine) Tablet, RediTabs, and Dry Syrup in Children (Study P05834)(COMPLETED)

Completed

Conditions: Pruritus
Rhinitis, Allergic, Seasonal
Rhinitis, Allergic, Perennial
Urticaria

Interventions: Drug: loratadine

First Posted Date: 2008-09-30

Last Posted Date: 2015-02-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1003

Registration Number: NCT00762983

Post Approval Pharmacokinetic Study of Loratadine in Japanese Pediatric and Adult Patients (Study P05539)

Phase 4

Completed

Conditions: Perennial Allergic Rhinitis

Interventions: Drug: loratadine

First Posted Date: 2008-08-08

Last Posted Date: 2017-04-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 261

Registration Number: NCT00730912

Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED)

Phase 3

Completed

Conditions: Rhinoconjunctivitis
Rhinitis
Conjunctivitis
Allergy

Interventions: Drug: Placebo
Biological: SCH 697243
Drug: Loratadine 10 mg Rescue Treatment
Drug: Olopatadine 0.1% Rescue Treatment
Drug: Mometasone 50 mcg Rescue Treatment
Drug: Prednisone 5 mg Rescue Treatment
Drug: Albuterol sulfate 108 mcg
Drug: Fluticasone propionate 44 mcg
Drug: Prednisone 5 mg

First Posted Date: 2007-11-21

Last Posted Date: 2017-03-03

Lead Sponsor: ALK-Abelló A/S

Target Recruit Count: 439

Registration Number: NCT00562159

A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis

Phase 4

Completed

Conditions: Seasonal Allergic Rhinitis

Interventions: Drug: Azelastine and placebo
Drug: Cetirizine and Placebo
Drug: Loratadine and Placebo
Drug: Placebo and Placebo (spray and Tablet)

First Posted Date: 2007-11-21

Last Posted Date: 2013-05-07

Lead Sponsor: Bayer

Target Recruit Count: 70

Registration Number: NCT00561717

Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED)

Phase 3

Completed

Conditions: Rhinitis
Rhinoconjunctivitis
Conjunctivitis
Allergy

Interventions: Biological: SCH 697243
Drug: Placebo
Drug: Loratadine Syrup 1 mg/mL Rescue Treatment
Drug: Loratadine 10 mg Rescue Treatment
Drug: Olopatadine 0.1% Rescue Treatment
Drug: Mometasone furoate 50 mcg Rescue Treatment
Drug: Albuterol 108 mcg Rescue Treatment
Drug: Fluticasone 44 mcg Rescue Treatment
Drug: Prednisone 5 mg Rescue Treatment

First Posted Date: 2007-10-30

Last Posted Date: 2017-03-03

Lead Sponsor: ALK-Abelló A/S

Target Recruit Count: 345

Registration Number: NCT00550550

Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria

Phase 2

Completed

Conditions: Chronic Urticaria

Interventions: Drug: Omalizumab 75-375 mg
Drug: Placebo to omalizumab
Drug: Loratadine
Drug: Clemastine

First Posted Date: 2007-06-04

Last Posted Date: 2011-10-21

Lead Sponsor: Novartis

Target Recruit Count: 49

Registration Number: NCT00481676

Locations: 🇩🇪
Novartis Investigative Site, Munich, Germany

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