Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01900054
Other study ID # TAU-284-18
Secondary ID
Status Completed
Phase Phase 3
First received July 3, 2013
Last updated November 10, 2015
Start date June 2013
Est. completion date November 2013

Study information

Verified date September 2015
Source Mitsubishi Tanabe Pharma Corporation
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 15 Years
Eligibility 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.

Study Design

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


Intervention

Drug:
Bepotastine besilate
Two TAU-284 5mg tablets will be taken orally twice a day

Locations

Country Name City State
Japan Reserch site Kanagawa

Sponsors (1)

Lead Sponsor Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. Epu — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with Adverse Events and Adverse Drug Reactions Up to Week 12 Yes
Secondary 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. 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). Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point (up to Week 12) No
Secondary 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 No
Secondary Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12 No
Secondary Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis baseline, Week2, Week4, Week6, Week8, Week10 and Week 12 No
Secondary Influence of Activities in Daily Life(Study, Outing, Sleeping) Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12 No
Secondary Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing) Week 12 or suspension No
See also
  Status Clinical Trial Phase
Completed NCT01654536 - A 6 Month Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis (PAR) Phase 4
Completed NCT01539304 - Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis Phase 3
Completed NCT01221285 - Development of Cockroach Immunotherapy by the Inner-City Asthma Consortium Phase 1
Terminated NCT00491374 - Study of Nasonex® in Improving Sleep Disturbances Related to Perennial Allergic Rhinitis (Study P04909)(TERMINATED) Phase 4
Completed NCT00783224 - A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512) Phase 3
Completed NCT04324918 - Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis Phase 3
Completed NCT02532179 - Subcutaneous Immunotherapy for Mouse in Adults Phase 1/Phase 2
Completed NCT01451541 - A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR). Phase 3
Enrolling by invitation NCT01062139 - Cosalin® Monotherapy Versus Cosalin® and Xarlin® Combination Therapy Phase 4
Completed NCT00405899 - Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections N/A
Completed NCT01549340 - Retrospective Record Review of Adults and Children Advised for Allergen Immunotherapy (MK-7243-022) N/A
Completed NCT01018862 - A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis Phase 3
Completed NCT00789555 - Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis Phase 4
Completed NCT00261287 - Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416) Phase 3
Completed NCT00974571 - Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246) Phase 3
Completed NCT04654702 - Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap.
Completed NCT05122143 - Efficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers N/A
Completed NCT01380327 - Biomarkers of Cockroach Sublingual Immunotherapy 2 Phase 1/Phase 2
Completed NCT01116778 - the Efficacy and Safety of Probiotics eN-Lac® Capsules of Children With Perennial Allergic Rhinitis Phase 3
Completed NCT00359216 - The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726) Phase 4