Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection

Study Overview
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Brief Summary
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This single-dose trial will evaluate the efficacy of a novel ibuprofen formulation compared to placebo in patients with a fever due to an uncomplicated acute infection.

Official Title
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Evaluation Of The Antipyretic Efficacy Of Ibuprofen Sodium Tablets In Subjects With An Uncomplicated Acute Infection

Conditions
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Infection

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects diagnosed with a fever secondary to an uncomplicated acute viral or bacterial infection. Oral temperature measurement from 100 to 104 degrees Fahrenheit. Onset of fever 3 days or less. Otherwise good health. Exclusion Criteria: Fever secondary to a chronic underlying medical condition or serious infection. Currently taking antibiotics or antivirals. Currently taking any medication which may interfere with the assessment of fever. Pregnancy or breast-feeding. Any serious medical or psychiatric disorder.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Ibuprofen<br>* Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen)<br>|
| Placebo Comparator: B<br> | Drug: Placebo<br>* Single dose of a placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6) | STEMPD 0-6 was defined as time-weighted sum of temperature differences over 6 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature. | 0 to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8) | STEMPD 0-4 and STEMPD 0-8 were defined as the time-weighted sum of temperature differences over 4 hours and 8 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature. | 0 to 4, 0 to 8 hours | 
| Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8 | Change from baseline in temperature was calculated as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature. | Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours | 
| Time to Treatment Failure | Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first. | 0 to 8 hours | 
| Cumulative Percentage of Participants With Treatment Failure | Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication. | 0.25, 0.5, 1, 2, 4, 6, 8 hours | 
| Global Assessment of Study Medication as an Antipyretic | Global assessment of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent. | 8 hours | 
| Rating of Study Medication Relative to Usual Medication | Rating of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent. | 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fever, antipyretic, uncomplicated acute viral infection, uncomplicated acute bacterial infections