Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection
- Registration Number
- NCT01035346
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Ibuprofen - B Placebo -
- Primary Outcome Measures
Name Time Method Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6) 0 to 6 hours 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.
- Secondary Outcome Measures
Name Time Method Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8) 0 to 4, 0 to 8 hours 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.
Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8 Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours 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.
Time to Treatment Failure 0 to 8 hours Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.
Cumulative Percentage of Participants With Treatment Failure 0.25, 0.5, 1, 2, 4, 6, 8 hours Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.
Global Assessment of Study Medication as an Antipyretic 8 hours 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.
Rating of Study Medication Relative to Usual Medication 8 hours 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Salt Lake City, Utah, United States