Claritin Clinical Trials and Studies

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Claritin Clinical Trials and Studies

Clinical trials of Claritin (loratadine) tablets involved over 10,700 patients, 12 years of age and older, who received either loratadine tablets or another antihistamine and/or placebo in double-blind randomized controlled studies. In placebo-controlled trials, 10 mg once daily of Claritin (loratadine) tablets was superior to placebo and similar to clemastine (1 mg bid) or terfenadine (60 mg bid) in effects on nasal and non-nasal symptoms of allergic rhinitis. In these studies somnolence occurred less frequently with Claritin (loratadine) tablets than with clemastine and at about the same frequency as terfenadine or placebo. In studies with Claritin (loratadine) tablets at doses 2 to 4 times higher than the recommended dose of 10 mg, a dose-related increase in the incidence of somnolence was observed. Therefore, some patients, particularly those with hepatic or renal impairment and the elderly, or those on medications that impair clearance of Claritin (loratadine) and its metabolites may experience somnolence. In addition, three placebo-controlled, double-blind, 2-week trials in 188 pediatric patients with seasonal allergic rhinitis aged 6 to 12 years, were conducted at doses of loratadine syrup up to 10 mg once daily.

Clinical trials of Claritin (loratadine) rapidly-disintegrating tablets involved over 1300 patients who received either Claritin (loratadine) rapidly-disintegrating tablets, Claritin (loratadine) tablets, or placebo. In placebo-controlled trials, one Claritin (loratadine) rapidly-disintegrating tablet once daily was superior to placebo and similar to Claritin (loratadine) tablets in effects on nasal and non-nasal symptoms of seasonal allergic rhinitis.

Among those patients involved in double-blind, randomized, controlled studies of loratadine tablets, approximately 1000 patients (age 12 and older), were enrolled in studies of chronic idiopathic urticaria. In placebo-controlled clinical trials, loratadine tablets 10 mg once daily were superior to placebo in the management of chronic idiopathic urticaria, as demonstrated by reduction of associated itching, erythema, and hives. In these studies, the incidence of somnolence seen with Claritin (loratadine) tablets was similar to that seen with placebo.

In a study in which Claritin (loratadine) tablets were administered to adults at 4 times the clinical dose for 90 days, no clinically significant increase in the QTc was seen on ECGs.

In a single-rising dose study in which doses up to 160 mg (16 times the clinical dose) were studied, Claritin (loratadine) did not cause any clinically significant changes on the QTc interval in the ECGs.

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