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

• ClinicalTrials.gov Identifier: NCT01425632
• Recruitment Status: Completed
• First Posted: August 30, 2011
• Results First Posted: December 14, 2015
• Last Update Posted: December 14, 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 the dose response, safety, and plasma concentrations of TAU-284.

Condition or disease	Intervention/treatment	Phase
Perennial Allergic Rhinitis	Drug: TAU-284; Drug: Placebo	Phase 3

Detailed Description:

This is a randomized, double-blind, placebo-controlled, 3-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (10 mg/day or 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 the dose response, safety, and plasma concentrations of TAU-284.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 490 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: August 2011
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: TAU-284 Low	Drug: TAU-284; TAU-284 Low
Experimental: TAU-284 High	Drug: TAU-284; TAU-284 High
Placebo Comparator: Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation) [ Time Frame: Baseline and Week 2 ]
   Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 4-point scale ranging from 0 (no symptoms) to 3 (severe) .

Secondary Outcome Measures :

1. Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] [ Time Frame: Week 2 ]
2. Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) [ Time Frame: Week 2 ]
3. Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) [ Time Frame: Week 2 ]
4. Change From Baseline in Severity Score [ Time Frame: Week 2 ]
5. Adverse Events and Adverse Drug Reactions [ Time Frame: Week 2 ]
6. Plasma Concentrations of Unchanged TAU-284 (Bepotastine Besilate) (at a Total of 3 Time Points, i.e., Before and 2 (±1) Hours After Study-drug Administration at Week 1 and Before Study-drug Administration at Week 2) [ 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 with a weight of at least 20 kg
• Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
• Patients with a mean rhinorrhea score of at least 2 and a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 4 on the basis of symptoms recorded in the nasal allergy diary during the observation period

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
• Patients with current or previous history of drug allergy
• Patients who concurrently have renal function abnormalities that may cause safety problems

Contacts and Locations

Locations

Japan

Reserch site

Chubu, Japan

Reserch site

Hokuriku, Japan

Reserch site

Kanto, Japan

Reserch site

Kinki, Japan

Reserch site

Kyusyu, Japan

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Investigators

• Study Director: Kimihiro Okubo, M.D. Ph.D.; Department of Otorhinolaryngology, Nippon Medical School

More Information

• Responsible Party: Mitsubishi Tanabe Pharma Corporation
• ClinicalTrials.gov Identifier: NCT01425632
• Other Study ID Numbers: TAU-284-17
• First Posted: August 30, 2011
• Results First Posted: December 14, 2015
• Last Update Posted: December 14, 2015
• Last Verified: September 2015

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

TAU-284; Bepotastine besilate; Histamine H1 receptor antagonists

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