Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02932774
Study type Interventional
Source Johnson & Johnson Consumer and Personal Products Worldwide
Contact
Status Completed
Phase Phase 4
Start date March 2001
Completion date July 2001

See also
  Status Clinical Trial Phase
Recruiting NCT05080322 - Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis Phase 4
Recruiting NCT06028490 - A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis. Phase 2
Completed NCT04388358 - Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation N/A
Recruiting NCT04202263 - Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline Phase 2
Completed NCT04078009 - Standardising Nasal Allergen Challenge in Adult With Hay Fever N/A
Completed NCT03644680 - Changes in Adaptive Immune Responses and Effector Cell Responses Upon Nasal Allergen Exposure - a Pilot Study N/A
Completed NCT04541004 - Adolescent Mite Allergy Safety Evaluation Phase 3
Recruiting NCT05378594 - HDM and Silver Birch NAC Standardisation N/A
Not yet recruiting NCT05684380 - Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER) Phase 3
Completed NCT02943720 - ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen Phase 2
Completed NCT02910401 - Clinical Response to Rhinovirus Challenge Phase 2
Not yet recruiting NCT01014325 - Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy Phase 3
Completed NCT02556801 - Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy Phase 2
Not yet recruiting NCT02233426 - Effect of Hypertonic Solutions on Allergic Rhinitis Patients N/A
Completed NCT02352168 - Airway Inflammation in Children With Allergic Rhinitis and Intervention N/A
Completed NCT01918956 - PURETHAL Birch RUSH Study Phase 4
Completed NCT01946035 - Alpha-Blockers in Allergic Rhinitis (MAN 01) Phase 4
Completed NCT01682070 - SUBLIVAC FIX Phleum Pratense DT/DRF Phase 2
Recruiting NCT01454492 - The Relationship Between Allergic Rhinitis and Geographic Tongue N/A
Completed NCT01439815 - An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo Phase 4