Exploration of the Optimal Dosage of Cetirizine in the Treatment of Allergic Diseases in Chinese Children

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

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-06

Study Completion Date

2024-05-31

Brief Summary

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To obtain the pharmacokinetics of cetirizine in Chinese children with allergic disease.

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Detailed Description

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Conditions

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Allergic Disease Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Pediatric patients treated with cetirizine

Pediatric patients who were being treated with cetirizine to fight allergic diseases.

Group Type EXPERIMENTAL

1-3 Cetirizine Pharmacokinetic samples

Intervention Type OTHER

Limited sampling strategy was used in this study. For each child, only 1\~3 blood samples were collected before and after cetirizine administration.

Interventions

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1-3 Cetirizine Pharmacokinetic samples

Limited sampling strategy was used in this study. For each child, only 1\~3 blood samples were collected before and after cetirizine administration.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. The informed consent form was voluntarily signed by the legal guardians of the subjects (children aged ≥8 years should participate in the informed consent process and sign the informed consent form).
2. Pediatric patients, whether they are outpatients or inpatients, who require oral cetirizine therapy.
3. The children was clinically diagnosed with allergic diseases such as eczema, urticaria, asthma, and allergic rhinitis.
4. Pediatric patients had not taken other antiallergic drugs 72 hours before screening.

Exclusion Criteria

1. Abnormal liver function (ALT or AST \> 2 times the upper limit of normal).
2. Abnormal renal function (serum creatinine above the upper limit of normal or GFR \< 10 mL/min)
3. Electrolyte abnormalities (potassium or magnesium \< 0.8 times lower limit of normal, \> 1.2 times upper limit of normal)
4. Children who were allergic to cetirizine or had a history of serious adverse reactions.
5. Pediatric patients with unstable vital signs.

Minimum Eligible Age

6 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No