NCT00938509

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 22, 2009

Status Verified

July 1, 2009

Enrollment Period

3 months

First QC Date

July 13, 2009

Last Update Submit

July 21, 2009

Conditions

Fever

Keywords

IBUPROFENCHILDRENFEVER

Outcome Measures

Primary Outcomes (1)

  • Fever decrease

    1 day

Interventions

ibuprofen suppositoriesDRUG

5-10 mg/kg/day-suppositories

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants and children with rectal temperature \> 38.5 C

You may not qualify if:

  • Infants \< 6 months of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

pediatric emergency room, SOROKA MEDICAL CENTER

Beersheba, Israel

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

EUGENE LEIBOVITZ, MD

CONTACT

972-8-6244065eugenel@bgu.ac.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2009

First Posted

July 14, 2009

Study Start

July 1, 2009

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

July 22, 2009

Record last verified: 2009-07

Locations

IL(1)