Back to resultsStudy Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection
Primary Purpose
Infection
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Infection focused on measuring Fever, antipyretic, uncomplicated acute viral infection, uncomplicated acute bacterial infections
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Cumulative Percentage of Participants With Treatment Failure
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01035346
Brief Title
Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection
Official Title
Evaluation Of The Antipyretic Efficacy Of Ibuprofen Sodium Tablets In Subjects With An Uncomplicated Acute Infection
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
Fever, antipyretic, uncomplicated acute viral infection, uncomplicated acute bacterial infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single dose of a placebo
Primary Outcome Measure Information:
Title
Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)
Description
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 Frame
0 to 6 hours
Secondary Outcome Measure Information:
Title
Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8)
Description
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.
Time Frame
0 to 4, 0 to 8 hours
Title
Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8
Description
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 Frame
Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours
Title
Time to Treatment Failure
Description
Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.
Time Frame
0 to 8 hours
Title
Cumulative Percentage of Participants With Treatment Failure
Description
Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.
Time Frame
0.25, 0.5, 1, 2, 4, 6, 8 hours
Title
Global Assessment of Study Medication as an Antipyretic
Description
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.
Time Frame
8 hours
Title
Rating of Study Medication Relative to Usual Medication
Description
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.
Time Frame
8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Facility Name
Pfizer Investigational Site
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25526232
Citation
Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=AH-09-12&StudyName=Study%20Evaluating%20The%20Efficacy%20Of%20A%20Novel%20Ibuprofen%20Formulation%20On%20Fever%20In%20Patients%20With%20An%20Uncomplicated%20Acute%20Infection
Description
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Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection
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