MedTrace Logo

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)

NCT02932774 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 683

Last updated 2017-04-20

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Johnson & Johnson Consumer and Personal Products Worldwide

    lead INDUSTRY

Principal Investigators

  • Dial Hewlett, MD · Medical Director; Pfizer, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-03-31
Primary Completion
2001-07-31
Completion
2001-07-31

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02932774 on ClinicalTrials.gov