The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

• ClinicalTrials.gov Identifier: NCT01861522
• Recruitment Status: Completed
• First Posted: May 23, 2013
• Results First Posted: December 15, 2015
• Last Update Posted: December 15, 2015
• Sponsor: Mitsubishi Tanabe Pharma Corporation
• Information provided by (Responsible Party): Mitsubishi Tanabe Pharma Corporation

Study Description

Brief Summary:

The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis and to investigate safety of TAU-284.

Condition or disease	Intervention/treatment	Phase
Perennial Allergic Rhinitis	Drug: Bepotastine besilate; Drug: Placebo	Phase 3

Detailed Description:

This is a randomized, double-blind, placebo-controlled, 2-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (20 mg/day) or placebo to pediatric patients with perennial allergic rhinitis, with "the change from baseline in total nasal symptom score (total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion])" as the primary endpoint; and to investigate safety of TAU-284.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 473 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (A Randomized, Double-blind, Placebo-controlled Study)
• Study Start Date: April 2013
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: TAU-284; Two TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).	Drug: Bepotastine besilate; Two TAU-284 5mg tablets will be taken orally twice a day; Other Name: TALION 5mg tablets
Placebo Comparator: Placebo; Two placebo tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).	Drug: Placebo; Two Placebo tablets will be taken orally twice a day

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] [ Time Frame: Baseline and Week 2 ]
   Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptoms) to 4 (very severe).

Secondary Outcome Measures :

1. Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] [ Time Frame: baseline, Week1 and Week 2 ]
2. Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) [ Time Frame: baseline, Week1 and Week 2 ]
3. Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) [ Time Frame: baseline, Week1 and Week 2 ]
4. Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis [ Time Frame: Randomization, Week1 and Week 2 ]
5. Adverse Events and Adverse Drug Reactions [ Time Frame: Week 2 ]

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 15 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients aged between 7 and 15 years
• Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
• Patients with a mean rhinorrhea score and a mean sneezing score of at least 2 on the basis of symptoms recorded in the nasal allergy diary during the observation period etc.

Exclusion Criteria:

• Patients with vasomotor rhinitis or eosinophilic rhinitis
• Patients who have concurrent nasal disease that may affect the efficacy of TAU-284
• Patients with a history of any of the nasal surgical procedures
• Patients who have a positive result for pollen antigens which are dispersed during the study period
• Patients who have a positive result for dog dander or cat dander antigen and have a chance to touch dogs or cats.
• Patients with current or previous history of drug allergy
• Patients who concurrently have renal function abnormalities that may cause safety problems etc.

Contacts and Locations

Locations

Japan

Reserch site

Fukuoka, Japan

Reserch site

Toyama, Japan

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Investigators

• Study Director: KIMIHIRO OKUBO; Nippon Medical School

More Information

Publications of Results:

Okubo K, Ichimura M, Koyama T, Susuta Y, Izaki H. Double-blind placebo-controlled study of bepotastine besilate in pediatric patients with perennial allergic rhinitis. Expert Opin Pharmacother. 2015;16(16):2395-408. doi: 10.1517/14656566.2015.1085511. Epub 2015 Sep 12.

• Responsible Party: Mitsubishi Tanabe Pharma Corporation
• ClinicalTrials.gov Identifier: NCT01861522
• Other Study ID Numbers: TAU-284-20
• First Posted: May 23, 2013
• Results First Posted: December 15, 2015
• Last Update Posted: December 15, 2015
• Last Verified: November 2015

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

TAU-284; Bepotastine besilate; Histamine H1 receptor antagonists; children

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bepotastine besilate; Anti-Allergic Agents