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Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap.

NCT ID: NCT04654702

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2671 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-17

Study Completion Date

2020-07-20

Brief Summary

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Investigator examines the past prescription patterns and the reasons for the change of prescription to Monterizine capsules for Perennial Allergic Rhinitis patients with Asthma who will be taking Monterizine capsules to treat allergic rhinitis.

After being given Monterizine capsules, Investigator evaluates the therapeutic effectiveness and safety for 3 months (or 6 months).

Detailed Description

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A Multi-center, Prospective, Observational Study

Conditions

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Perennial Allergic Rhinitis Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Male or female aged ≥ 15 years
2. Perennial allergic rhinitis patients with asthma who will be prescribed Monterizine capsules to treat allergic rhinitis
3. Patients who provided a signed written informed consent form

Exclusion Criteria

1. Highly sensitive patients to ingredients of Monterizine capsules, hydroxyzine or piperazine derivatives
2. Patients with renal failure(CLCR,10ml/min) and hemodialysis patients
3. A female who is pregnant, may be pregnant, or is lactating
4. Patients with genetic problems like Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Byoung-Whui Choi

Role: PRINCIPAL_INVESTIGATOR

59 institutions including Chung-Ang University Hospital

Locations

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59 institutions including Chung-Ang University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HM-MONT-OS-01

Identifier Type: -

Identifier Source: org_study_id