Skip to content

Evaluate the safety and efficacy of dexibuprofen in improving fever symptoms in children aged 6 months to 3 years old Multi center post marketing clinical research plan

Evaluate the safety and efficacy of dexibuprofen in improving fever symptoms in children aged 6 months to 3 years old Multi center post marketing clinical research plan

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105536
Enrollment
Unknown
Registered
2025-07-04
Start date
2024-12-28
Completion date
Unknown
Last updated
2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RTI(respiratory tract infection)

Interventions

Observation group:Oral Dextroprofen Suspension
Control group:Oral ibuprofen (Meilin)

Sponsors

The Second Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.The diagnosis of upper or lower respiratory tract infection is when the axillary temperature of the child is >= 38.5 ? and = 6 months and <= 3 years old; 3.Not using any antipyretic or analgesic drugs within 6 hours of fever; 4.Not using glucocorticoids within 24 hours of fever; 5.No serious underlying diseases, such as congenital heart disease, asthma, tumors, blood disorders, liver, liver, and kidney dysfunction; 6.Voluntarily participating in this study, the child's legal guardian signed an informed consent form, and the process of obtaining informed consent complied with GCP regulations.

Exclusion criteria

Exclusion criteria: 1.Those who have taken ibuprofen oral suspension or used preparations containing ibuprofen within 6 hours of fever; 2.Those who have taken acetaminophen suspension or preparations containing acetaminophen within 6 hours of fever; 3.Those who have used traditional Chinese medicine with antipyretic ingredients within 6 hours of fever or have used glucocorticoid within 24 hours; 4.Children with rash or chickenpox; 5.Children with severe malnutrition; 6.Patients with heart failure or other organ dysfunction during the visit; 7.Patients with signs of dehydration or high fever crisis during medical treatment; 8.Individuals at risk of high fever within 6 months prior to seeking medical attention; 9.Patients with active digestive ulcers during the visit; 10.Individuals with potential bleeding tendency or active bleeding symptoms during medical consultation; 11.Individuals who have previously been allergic to ibuprofen or acetaminophen drugs; Patients who have experienced asthma, rhinitis, or urticaria due to taking aspirin and other nonsteroidal anti-inflammatory drugs; 12.Individuals with a history of kidney, liver, lung, endocrine, blood, or heart diseases prior to seeking medical attention, who have completed treatment for less than 6 months; 13.Individuals with central nervous system abnormalities during medical treatment; 14.Currently uncontrolled type 1 or type 2 diabetes patients; 15.Children with symptoms such as tuberculosis, sepsis, rheumatic fever, typhoid fever, local suppurative lesions, and prolonged fever; 16.Due to other uncertain factors, the researcher has determined that they are not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Difference in temperature change after 4 hours of administration;

Secondary

MeasureTime frame
Improvement in Comfort Level;Gastrointestinal symptom evaluation;Safety indicators;

Countries

China

Contacts

Public ContactYang Liu

The Second Affiliated Hospital of Nanchang University

ocean3166@yeah.net+86 13767038359

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026