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

• Sponsor: Mitsubishi Tanabe Pharma Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01900054
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 11.5

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Perennial Allergic Rhinitis	Drug: Bepotastine besilate	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 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 Names: TALION 5mg tablets

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Adverse Events and Adverse Drug Reactions [Up to Week 12]

Secondary Outcome Measures

1. Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point. [Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）]

   Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptom) to 4 (very severe).

2. Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) [baseline, Week2, Week4, Week6, Week8, Week10 and Week 12]

3. Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) [Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12]

4. Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis [baseline, Week2, Week4, Week6, Week8, Week10 and Week 12]

5. Influence of Activities in Daily Life(Study, Outing, Sleeping) [Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12]

6. Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing) [Week 12 or suspension]

Eligibility Criteria

Criteria

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

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

Locations

	Site	City	State	Country	Postal Code
1	Reserch site	Kanagawa		Japan

Sponsors and Collaborators

• Mitsubishi Tanabe Pharma Corporation

Investigators

• Study Director: KIMIHIRO OKUBO, Nippon Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mitsubishi Tanabe Pharma Corporation
• ClinicalTrials.gov Identifier: NCT01900054
• Other Study ID Numbers: TAU-284-18
• First Posted: Jul 16, 2013
• Last Update Posted: Apr 8, 2016
• Last Verified: Sep 1, 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; Bepotastine besilate

Study Results

Participant Flow

Arm/Group Title	TAU-284
Arm/Group Description	TAU-284 10mg twice daily for 12 weeks
Period Title: Overall Study
STARTED	58
COMPLETED	56
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	TAU-284
Arm/Group Description	TAU-284 10mg twice daily for 12 weeks
Overall Participants	58
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	11.2 (2.3)
Sex: Female, Male (Count of Participants)
Female	25 43.1%
Male	33 56.9%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Adverse Events and Adverse Drug Reactions
Time Frame	Up to Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAU-284
Arm/Group Description	TAU-284 10mg twice daily for 12 weeks
Measure Participants	58
Adverse events	37 63.8%
Adverse drug reactions	2 3.4%

2. Secondary Outcome

Title	Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point.
Description	Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptom) to 4 (very severe).
Time Frame	Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAU-284
Arm/Group Description	TAU-284 10mg twice daily for 12 weeks
Measure Participants	58
Week 2	-0.943 (1.549)
Week 4	-1.388 (1.465)
Week 6	-1.321 (1.844)
Week 8	-1.433 (1.880)
Week 10	-1.460 (1.777)
Week 12	-1.451 (1.707)
final evaluation point	-1.440 (1.678)

3. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
Time Frame	Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis
Time Frame	baseline, Week2, Week4, Week6, Week8, Week10 and Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Influence of Activities in Daily Life(Study, Outing, Sleeping)
Time Frame	Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)
Time Frame	Week 12 or suspension

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	TAU-284
Arm/Group Description	TAU-284 10mg twice daily for 12 weeks
All Cause Mortality
	TAU-284
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	TAU-284
	Affected / at Risk (%)	# Events
Total	0/58 (0%)
Other (Not Including Serious) Adverse Events
	TAU-284
	Affected / at Risk (%)	# Events
Total	31/58 (53.4%)
Infections and infestations
Nasopharyngitis	19/58 (32.8%)
Otitis externa	3/58 (5.2%)
Pharyngitis	3/58 (5.2%)
Investigations
Liver function test abnormal	2/58 (3.4%)
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation	5/58 (8.6%)
Epistaxis	2/58 (3.4%)
Skin and subcutaneous tissue disorders
Eczema	2/58 (3.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.