WAL801CL (Epinastine Hydrochloride) Dry Syrup in Paediatric Perennial Allergic Rhinitis

NCT02182544 | Completed Phase 3

• 1 other identifier: 262.258
• Study Type: interventional
• Target: 151
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the efficacy of WAL801CL Dry Syrup in comparison with ketotifen fumarate on pediatric perennial allergic rhinitis and to evaluate the safety of WAL801CL Dry Syrup compared to ketotifen fumarate and to confirm the appropriateness of dosage of WAL801 Dry Syrup.

Conditions

Rhinitis, Allergic, Perennial

Outcome Measures

Primary Outcomes (1)

• Total severity scores of nasal symptoms judged by the physician

  2 weeks of first administration of study drug

Secondary Outcomes (7)

• Severity score for each nasal symptom given by the physician

  2 weeks of first administration of study drug

• Nasal symptom score in the diary

  2 weeks

• Total scores for nasal symptoms in the diary

  2 weeks of first administration of study drug

• Severity score for allergic rhinitis according to the Allergic Rhinitis Severity Classification

  2 weeks

• Impression of the patient or the parent

  week 2 after first administration of study drug

Study Arms (2)

WAL801CL dry syrup + Placebo

EXPERIMENTAL

Drug: WAL801CL dry syrup; Drug: Ketotifen fumarate dry syrup placebo

Ketotifen fumarate dry syrup + Placebo

ACTIVE COMPARATOR

Drug: Ketotifen fumarate dry syrup; Drug: WAL 801 CL dry syrup placebo

Interventions

WAL801CL dry syrup DRUG

WAL801CL dry syrup + Placebo

Ketotifen fumarate dry syrup DRUG

Ketotifen fumarate dry syrup + Placebo

Ketotifen fumarate dry syrup placebo DRUG

WAL801CL dry syrup + Placebo

WAL 801 CL dry syrup placebo DRUG

Ketotifen fumarate dry syrup + Placebo

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years of age or younger
• Body weight of 14 kg or more
• Typical symptoms of perennial allergic rhinitis, and within 2 or higher score of serum specific immunoglobulin E (IgE) caused by house dust (HD) or mite in the data obtained with the past one year
• "Moderate" or "Severe" in the Allergic Rhinitis Severity Classification during the observation period
• The Patient Diary can be entered by the patient or parent
• Outpatients

You may not qualify if:

• Absolute necessity of treatment with a drug that may affect the evaluation of the effect of the investigational drug (e.g., anti-histamines, anti-allergics, steroid, vasopressors). Patients being treated with the following drugs, however, may be included
• Intal® Oral or Inhalation
• Any eye drops other than Zaditen® Eye Drop
• External preparations (liniment, poultice)
• Initiation of desensitisation therapy within the past 6 months
• Onset of acute upper respiratory inflammation during the observation period
• Nasal disease, such as acute or chronic rhinitis, nasal polyp, hypertrophic rhinitis, septal deviation\*, sinusitis\*, and hypertrophied adenoid\*, of such a degree that the disease affects evaluation of the effect of the test drug (\*: X-ray examination will be conducted if necessary)
• That pollen (cider, ragweed, Japanese cypress, orchard grass, etc.) is a double antigen, and that the study will be conducted in the season of air-borne pollen, and symptoms may be exacerbated by pollen
• Present or past history of a convulsive disease, such as epilepsy (convulsion threshold values may be decreased by the comparator drug, ketotifen fumarate)
• Past history of drug allergy
• month, or 6 times as long as the half life of the investigational drug if it is over 1 month, will not have passed since participation in any other clinical trial study, at the time of the initiation of this study

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: June 1, 2001
• Primary Completion: December 1, 2001
• Last Updated: July 14, 2014

Record last verified: 2014-07