Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection
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ClinicalTrials.gov Identifier: NCT01035346 |
Recruitment Status :
Terminated
First Posted : December 18, 2009
Results First Posted : August 21, 2012
Last Update Posted : August 21, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infection | Drug: Ibuprofen Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Evaluation Of The Antipyretic Efficacy Of Ibuprofen Sodium Tablets In Subjects With An Uncomplicated Acute Infection |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | May 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: A |
Drug: Ibuprofen
Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen) |
Placebo Comparator: B |
Drug: Placebo
Single dose of a placebo |
- Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6) [ Time Frame: 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.
- Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

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Ages Eligible for Study: | 12 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01035346
United States, California | |
Pfizer Investigational Site | |
Cypress, California, United States, 90630 | |
Pfizer Investigational Site | |
Westlake Village, California, United States, 91361 | |
United States, Nebraska | |
Pfizer Investigational Site | |
Omaha, Nebraska, United States, 68144 | |
United States, Pennsylvania | |
Pfizer Investigational Site | |
Pittsburgh, Pennsylvania, United States, 15241 | |
United States, Utah | |
Pfizer Investigational Site | |
Salt Lake City, Utah, United States, 84124 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01035346 History of Changes |
Other Study ID Numbers: |
AH-09-12 |
First Posted: | December 18, 2009 Key Record Dates |
Results First Posted: | August 21, 2012 |
Last Update Posted: | August 21, 2012 |
Last Verified: | July 2012 |
Fever antipyretic uncomplicated acute viral infection uncomplicated acute bacterial infections |
Infection Communicable Diseases Ibuprofen Antipyretics Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |