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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01425632
First received: August 28, 2011
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Perennial Allergic Rhinitis
 Drug: TAU-284
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Change from baseline in total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] (at final evaluation) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Change from baseline in individual nasal symptom scores (sneezing, rhinorrhea, nasal congestion, and impairment in daily activities) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Change from baseline in individual scores for local nasal findings (rhinoscopic findings) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Change from baseline in severity score [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Adverse events and adverse drug reactions [ Time Frame: Week 2 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 490
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   7 Years to 15 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425632

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

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01425632     History of Changes
Other Study ID Numbers: TAU-284-17
Study First Received: August 28, 2011
Last Updated: March 20, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
TAU-284
Bepotastine besilate
Histamine H1 receptor antagonists

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013