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

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06288334
• Other study ID #: PUTH PD_V 1.2
• Status: Recruiting
• Phase: Phase 4
• Start date: August 6, 2020
• Est. completion date: May 31, 2024

Study information

• Verified date: February 2024
• Source: Peking University Third Hospital
• Contact: Dongyang Liu
• Phone: (86)010-82266658
• Email: liudongyang[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Disease
• Children

Intervention

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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration		0.5 ~ 48 hours before and after administration