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NCT00938509 Clinical Trial

Ibuprofen Suppositories Administration in Infants and Children

Fever Clinical Trial

Official title:
Ibuprofen Suppositories Administration for Fever Treatment in Infants and Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00938509
Other study ID # sor477208ctil
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received July 13, 2009
Last updated July 21, 2009
Start date July 2009
Est. completion date December 2009

Study information
Verified date July 2009
Source Soroka University Medical Center
Contact EUGENE LEIBOVITZ, MD
Phone 972-8-6244065
Email eugenel@bgu.ac.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The study will evaluate the efficacy of Ibuprofen administered as suppositories in the treatment of fever in infants and children. Ibuprofen as suppositories is not yet registered in Israel, although widely used in Europe.

Description:

The drug will be used in 100 consecutive infants and children admitted with fever at the pediatric ER of the Soroka Medical Center. The information on the drug efficacy will be collected in appropriate parental questionnaires.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 12 Years
Eligibility Inclusion Criteria:

- Infants and children with rectal temperature > 38.5 C

Exclusion Criteria:

- Infants < 6 months of age

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ibuprofen suppositories
5-10 mg/kg/day-suppositories

Locations
Country Name City State
Israel pediatric emergency room, SOROKA MEDICAL CENTER Beer Sheva
Israel pediatric emergency room, SOROKA MEDICAL CENTER Beer Sheva

Sponsors (1)
Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fever decrease 1 day No
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