A Long-Term 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:
NCT01900054
First received: July 3, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

The objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: Bepotastine besilate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Adverse events and adverse drug reactions [ Time Frame: Up to Week 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] [ Time Frame: baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and final evaluation point ] [ Designated as safety issue: No ]
  • Change from baseline in individual nasal symptom scores (sneezing, rhinorrhea, nasal congestion, and impairment in daily activities) [ Time Frame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in individual scores for local nasal findings (rhinoscopic findings) [ Time Frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in severity score for symptoms of allergic rhinitis [ Time Frame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12 ] [ Designated as safety issue: No ]
  • Influence of activities in daily life(study, outing, sleeping) [ Time Frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12 ] [ Designated as safety issue: No ]
  • Patient impression of nasal symptoms(sneezing, rhinorrhea, nasal congestion, nasal pruritus, eye pruritus and eye tearing) [ Time Frame: Week 12 or suspension ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: June 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

This is a multicenter,open-label, single-arm, uncontrolled study to evaluate the safety and efficacy of TAU-284 (20 mg/day) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.

  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 who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
  • Patients with a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 3 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 with current or previous history of drug allergy
  • Patients who concurrently have renal function abnormalities that may cause safety problems etc.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01900054

Locations
Japan
Reserch site
Kanagawa, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: KIMIHIRO OKUBO Nippon Medical School
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01900054     History of Changes
Other Study ID Numbers: TAU-284-18
Study First Received: July 3, 2013
Last Updated: April 14, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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 July 23, 2014