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 | Completed Phase 4 DMC

• 1 other identifier: A1431009
• Study Type: interventional
• Target: 683
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

SAR; seasonal allergic rhinitis; hay fever; seasonal allergic rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Change from baseline to the Overall endpoint in the subject 24-hour reflective total symptom severity complex (TSSC) score

  2 weeks

Secondary Outcomes (8)

• Change from baseline to the Overall endpoint in the subject 24-hour reflective TSSC, with and without stuffy nose score

  2 weeks

• Change from baseline to the Overall endpoint in the individual rhinoconjunctivitis symptoms (reflective and instantaneous)

  2 weeks

• Investigator evaluation of rhinoconjunctivitis symptoms

  2 weeks

• Parent/legal guardian evaluation of subject's rhinoconjunctivitis symptoms

  2 weeks

• Investigator Global Evaluations of Efficacy at Visit 4/early termination

  2 weeks

Study Arms (3)

Cetirizine 10 mg

EXPERIMENTAL

Cetirizine HCl 10 mg (1 mg/ml) syrup once daily for 2 weeks. Subjects who were randomized to receive cetirizine HCl syrup also received placebo syrup. Each subject was instructed to take 2 teaspoons from Bottle A and 2 teaspoons from Bottle B once daily, before 10:00 AM.

Drug: Cetirizine

loratadine 10 mg

ACTIVE COMPARATOR

Loratadine 10 mg (1 mg/ml) syrup once daily for 2 weeks. Subjects who were randomized to receive loratadine syrup also received placebo syrup. Each subject was instructed to take 2 teaspoons from Bottle A and 2 teaspoons from Bottle B once daily, before 10:00 AM.

Drug: Loratadine

placebo

PLACEBO COMPARATOR

Placebo syrup once daily for 2 weeks. Both placebo syrups were received by subjects who were randomized to receive placebo. Each subject was instructed to take 2 teaspoons from Bottle A and 2 teaspoons from Bottle B once daily, before 10:00 AM.

Other: Placebo

Interventions

Cetirizine DRUG

Cetirizine HCl 10 mg (1 mg/ml) syrup once daily before 10:00 AM for 2 weeks

Also known as: ZYRTEC

Cetirizine 10 mg

Loratadine DRUG

Loratadine HCl 10 mg (1 mg/ml) syrup once daily before 10:00 AM for 2 weeks

Also known as: CLARITIN

loratadine 10 mg

Placebo OTHER

Placebo syrup once daily before 10:00 AM for 2 weeks

placebo

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female 6 to 11 years of age.
• Females who reached menarche either before or during the study, agreed to use acceptable methods of birth control if they became sexually active. Acceptable birth control was defined as oral contraceptives or Norplant®.
• Outpatient.
• History and diagnosis of seasonal allergic rhinitis (SAR) to a prevalent allergen (grass or tree).
• SAR to a prevalent allergen (grass or tree) of such severity that it required pharmacologic therapy each year for the last 2 consecutive years (including the present year).
• Documented SAR to a prevalent allergen (grass or tree) as confirmed by a recognized skin test (prick, intradermal \[ID\], or Multitest®) within the previous 15 months (Prick/Puncture wheal® ≥3 mm over the negative control; ID \[up to concentration of 1:1000 w/v or 1000 protein nitrogen units (PNU)\] wheal® ≥5 mm over the negative control). Documentation of SAR must have occurred at Visit 1 or within 15 months prior to Visit 1. If not performed at Visit 1, SAR testing must have been performed in the Principal Investigator's office or full documentation must have been available prior to randomization.
• Diary-recorded rhinoconjunctivitis symptom scores (24 hour reflective) that included at least two symptoms (sneezing, runny nose, itchy eyes, or watery eyes) at moderate severity (i.e., symptom score ≥2) on at least 4 days between Visits 1 and 2.
• Diary-recorded TSSC score ≥5 (based on the four symptoms noted in the criteria above) on any 4 days between Visits 1 and 2.
• Someone (subject and parent/legal guardian) from whom the Principal Investigator or study personnel would have expected conscientious cooperation over the duration of the study.
• A written informed assent must have been provided by the subject and a written informed consent must have been provided by the parent/legal guardian at Visit 1.

You may not qualify if:

• Had clinically significant nasal anatomical deformities with \> 50% obstruction (i.e., septal defects, polyps).
• Experienced an episode of acute sinusitis or an upper respiratory tract infection (URTI) including otitis media and the common cold) within 21 days of Visit 1.
• Had a history of chronic sinusitis.
• Initiated or advanced an immunotherapy regimen during the course of the study. Subjects receiving a maintenance dose of immunotherapy were eligible.
• Had a history of attention deficit/hyperactivity disorder (ADHD) that was considered unstable by the Investigator, or if pharmacotherapy (i.e., Ritalin®, Adderall®) was required, subject must have been on pharmacotherapy for at least 1 month prior to Visit 1. The pharmacotherapeutic regimen was to remain stable during the conduct of the study.
• Had a history of learning disabilities or intellectual impairment that, in the opinion of the Investigator, would prevent the subject from participating in the study.
• Had impaired hepatic function (cirrhosis, hepatitis), glaucoma, or any symptomatic infection, any clinically significant hematologic, renal, endocrine, or gastrointestinal disease, and/or current neuropsychiatric condition with or without drug therapy, that was judged by the Investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial.
• Had a history of malignancy (except basal cell carcinoma), epilepsy or seizures (excluding febrile seizures), excessive alcohol intake or drug addiction, hypertension, or other clinically significant cardiovascular disease.
• Had a physical examination abnormality considered by the Investigator to be clinically significant and limiting to the study's conduct, unless the abnormality was related to underlying allergic rhinitis.
• Had a history of an allergy or hypersensitivity to cetirizine, loratadine, hydroxyzine, or any of their ingredients.
• Had asthma, which required any of the following within the past 30 days: 1) admission to the hospital, 2) emergency room visit, or 3) a change in dosing regimen. Subjects were allowed to continue theophylline, long acting β2 agonists, inhaled cromoglycate no more than 6.4 mg/day, or nedocrimil no more than 14 mg/day. Subjects were allowed to continue inhaled corticosteroids in doses not exceeding those listed in Appendix B of the study protocol, as long as the dose did not change during the study. Subjects were allowed the use of short acting β2 agonists on an as needed (PRN) basis.
• Had used intranasal or intra ophthalmic corticosteroids; oral leukotriene modifiers or leukotriene receptor antagonists within 14 days; or systemic (intramuscular and/or intravenous and/or oral) corticosteroids within 35 days prior to Visit 2. Topical corticosteroids for skin were allowed if covering ≤10% of body surface without occlusion.
• Used intranasal cromolyn (Nasalcrom®), optical cromolyn (Crolom®), ipratropium bromide (Atrovent® Nasal Spray), azelastine hydrochloride (Astelin® Nasal Spray), monamine oxidase (MAO) inhibitors, or beta blockers for the treatment of migraine headaches within 14 days prior to Visit 2.
• Used antiallergic ophthalmic treatments such as Acular®, Patanol®, or Alomide® within 7 days prior to Visit 2.
• Used H1-receptor antagonists (oral and topical), H2-receptor antagonists, or decongestants after Visit 1.

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead
• Pfizer: collaborator

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis, Allergic, Seasonal

Interventions

Cetirizine; Loratadine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Polycyclic Compounds

Study Officials

• Dial Hewlett, MD

  Medical Director; Pfizer, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 13, 2016
• Study Start: March 1, 2001
• Primary Completion: July 1, 2001
• Study Completion: July 1, 2001
• Last Updated: April 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share