FeverPhase 4NCT00729976
Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.
A Phase 4 study testing Ibuprofen suppository and Ibuprofen Suspension in people with Fever, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Fever is one of the most common symptoms in pediatrics and one of the most common reasons for visits in pediatricians' office and pediatric emergency departments. Many parents consider fever to be the most terrifying symptom. Ibuprofen is an effective and safe treatment for febrile children. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Fever
- What is being tested?
- Ibuprofen suppository and Ibuprofen Suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2008to Jun 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 3 mo- 4 years
- Weight 6 - 18 kg
- Rectal temperature > 38.50
Who cannot join
- Treatment with acetaminophen in the last 4 hours
- Treatment with Ibuprofen in the last 6 hours
- Unable to take oral or rectal medications
- Hypersensitivity to ibuprofen
- Renal failure
- Liver disease
- Rectal temperature can't be measured (due to anatomical or medical problem)
- Informed consent could not be granted
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofeh Medical Center
Tsrifin, 70300
Eran Kozer, MD, 97289779916, erank@asaf.health.gov.il
About this study
Fever is one of the most common symptoms in pediatrics and one of the most common reasons for visits in pediatricians' office and pediatric emergency departments. Many parents consider fever to be the most terrifying symptom.
Ibuprofen is an effective and safe treatment for febrile children. Until recently ibuprofen was available only in tablets suspension and as a liquid gel. All these dosage form are administered orally. Rectal suppositories are often essential for treating febrile children who cannot take medications by mouth (e.g vomiting). In the current study we aim to compare the effect on fever of ibuprofen given as suspension with ibuprofen suppositories.
- Conditions
- Fever
- Being tested
- Ibuprofen suppository, Ibuprofen Suspension
- Keywords
- Ibuprofen, Suppository, febrile children
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen suppositoryDrug
5-10mg/Kg of ibuprofen
Ibuprofen SuspensionDrug
5-10mg/Kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ibuprofen Suppository Receives: Drug: Ibuprofen suppository |
| 2 | Active comparator | Ibuprofen suspension Receives: Drug: Ibuprofen Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal change in temperature during the 4-hour period after enrollment.
Measured: 4 hours
Secondary outcomes (1)
Proportion of patients with a drop of at least 1°C and 2°C in mean temperature at 4h. Decrement in fever at each time point, and the area under the temperature (versus time) curve. Proportion of patients with temperature < 38 at 4 hours.
Measured: 4 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2010 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729976
- Sponsor's protocol ID
- 091/08
- Status last verified
- Mar 2010
- First submitted
- 6 Aug 2008
- Last updated
- 5 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.
- ClinicalTrials.gov ID
- NCT00729976
- Acronym / sponsor ID
- 091/08
- Conditions
- Fever
- Keywords
- Ibuprofen, Suppository, febrile children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Sep 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fever is one of the most common symptoms in pediatrics and one of the most common reasons for visits in pediatricians' office and pediatric emergency departments. Many parents consider fever to be the most terrifying symptom.
Ibuprofen is an effective and safe treatment for febrile children. Until recently ibuprofen was available only in tablets suspension and as a liquid gel. All these dosage form are administered orally. Rectal suppositories are often essential for treating febrile children who cannot take medications by mouth (e.g vomiting). In the current study we aim to compare the effect on fever of ibuprofen given as suspension with ibuprofen suppositories.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ibuprofen suppositoryIbuprofen Suppository |
| 2 | Active comparator | Drug: Ibuprofen SuspensionIbuprofen suspension |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 3 mo- 4 years
- Weight 6 - 18 kg
- Rectal temperature > 38.50
Key exclusion criteria (8 listed)
- Treatment with acetaminophen in the last 4 hours
- Treatment with Ibuprofen in the last 6 hours
- Unable to take oral or rectal medications
- Hypersensitivity to ibuprofen
- Renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen suppository5-10mg/Kg of ibuprofen | Drug | 1 |
| Ibuprofen Suspension5-10mg/Kg | Drug | 2 |
Primary outcome
Maximal change in temperature during the 4-hour period after enrollment.
Time frame: 4 hours
1 secondary outcome
Proportion of patients with a drop of at least 1°C and 2°C in mean temperature at 4h. Decrement in fever at each time point, and the area under the temperature (versus time) curve. Proportion of patients with temperature < 38 at 4 hours.
Time frame: 4 h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen suppository and Ibuprofen Suspension in people with Fever, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eran Kozer, MD (972 8 9779916, erank@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal change in temperature during the 4-hour period after enrollment. (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2011.