NCT02932774

Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-Center Study of the Efficacy and Safety of Cetirizine HCl Syrup vs. Loratadine Syrup vs. Placebo in Treatment of Children With Seasonal Allergic Rhinitis (SAR)

Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-Center Study of the Efficacy and Safety of Zyrtec® (Cetirizine HCl) Syrup vs. Claritin® (Loratadine) Syrup vs. Placebo in Treatment of Children With Seasonal Allergic Rhinitis (SAR)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 683 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical trial was to assess the efficacy and safety of cetirizine HCl syrup vs. loratadine syrup vs. placebo syrup in the treatment of SAR in children 6 to 11 years old.

Detailed description

This was a multi-center, randomized, double-blind, parallel-group, placebo-controlled, double dummy study of children with SAR conducted during the Spring tree and grass allergy season. Subjects qualified for randomization if the diary cards included (1) symptom scores of ≥2 for at least 2 of the following 4 rhinoconjunctivitis symptoms on 4 or more days: sneezing, runny nose, itchy eyes, and watery eyes; and (2) a total rhinoconjunctivitis (or Total Symptom Severity Complex \[TSSC\]) score of ≥5 on any 4 days. The TSSC score was expressed as the sum of the 4 individual symptoms scores recorded in the daily diary cards for the following symptoms: sneezing, runny nose, itchy eyes, and watery eyes. Subjects were randomized to receive 1 of 3 treatments in a double-blind fashion using a 1:1:1 allocation ratio: cetirizine HCl syrup and placebo loratadine syrup; loratadine syrup and placebo cetirizine HCl syrup; or cetirizine placebo syrup and loratadine placebo syrup. Number of Subjects (Planned and Analyzed): 1100 planned; 1536 screened; 683 randomized: 231 (33.8%) randomized to the cetirizine HCl treatment group, 221 (32.4%) to the loratadine treatment group, and 231 (33.8%) to the placebo treatment group. Test Product and Reference Therapy: Subjects randomized to receive cetirizine HCl syrup also received placebo syrup; subjects randomized to receive loratadine syrup also received placebo syrup; and both placebo syrups were received by subjects randomized to receive placebo. Duration of Double-Blind Treatment: 2 weeks. Safety measures included the incidence and severity of treatment-emergent adverse events (AEs), vital signs, concomitant medications, and physical examination findings. Clinical laboratory evaluation was not required for this study. Statistical Methods: All statistical tests related to treatment effect were 2-sided, and statistical significance was declared at the 0.05 probability level. Least squares means (LSMeans) were used to estimate treatment effect. Populations analyzed included the Full Analysis (intent-to-treat \[ITT\]) Set (FAS), Per-Protocol Set (PPS), Safety-Analyzable Set, and All-Screened Analysis Set. Demographic and baseline data for all subjects in the Safety-Analyzable Set were summarized and listed. The effects of treatment at the Overall and all other analysis Time Points were assessed using ANCOVA models. The main effects model contained terms for treatment and Investigator site, with baseline TSSC value as a covariate. The LSMeans and standard errors were based on the main effects model. Methods of analysis of secondary efficacy data included analysis of covariance (ANCOVA) models and Cochran-Mantel-Haenszel (CMH) row mean scores tests. Analysis of drug safety included the incidence of treatment-emergent AEs (TEAE), concomitant medications, vital signs, and physical examination findings for the Safety-Analyzable Set.

Conditions

• Allergic Rhinitis
• Hay Fever
• SAR
• Rhinitis, Allergic, Seasonal

Interventions

Type	Name	Description
DRUG	Cetirizine	Cetirizine HCl 10 mg (1 mg/ml) syrup once daily before 10:00 AM for 2 weeks
DRUG	Loratadine	Loratadine HCl 10 mg (1 mg/ml) syrup once daily before 10:00 AM for 2 weeks
OTHER	Placebo	Placebo syrup once daily before 10:00 AM for 2 weeks

Timeline

• Start date: 2001-03-01
• Primary completion: 2001-07-01
• Completion: 2001-07-01
• First posted: 2016-10-13
• Last updated: 2017-04-20