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

February 24, 2024 updated by: Dongyang Liu, Peking University Third Hospital
To obtain the pharmacokinetics of cetirizine in Chinese children with allergic disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Principal Investigator:
          • Wei Liu
        • Principal Investigator:
          • Dongyang Liu
        • Principal Investigator:
          • Wei Zhou
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pediatric patients treated with cetirizine
Pediatric patients who were being treated with cetirizine to fight allergic diseases.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration
Time Frame: 0.5 ~ 48 hours before and after administration
0.5 ~ 48 hours before and after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Wei Zhou, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2020

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

February 16, 2024

First Submitted That Met QC Criteria

February 24, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 24, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUTH PD_V 1.2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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