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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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ClinicalTrials.gov Identifier: NCT01035346
Recruitment Status : Terminated
First Posted : December 18, 2009
Results First Posted : August 21, 2012
Last Update Posted : August 21, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Infection
Interventions Drug: Ibuprofen
Drug: Placebo
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Ibuprofen Sodium
Hide Arm/Group Description Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet. Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
Period Title: Overall Study
Started 7 9
Completed 7 9
Not Completed 0 0
Arm/Group Title Placebo Ibuprofen Sodium Total
Hide Arm/Group Description Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet. Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen. Total of all reporting groups
Overall Number of Baseline Participants 7 9 16
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 9 participants 16 participants
31.4  (15.3) 37.3  (17.9) 34.8  (16.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 9 participants 16 participants
Female
2
  28.6%
4
  44.4%
6
  37.5%
Male
5
  71.4%
5
  55.6%
10
  62.5%
Body Temperature  
Mean (Standard Deviation)
Unit of measure:  Degrees Fahrenheit
Number Analyzed 7 participants 9 participants 16 participants
100.99  (0.83) 100.58  (0.66) 100.76  (0.74)
1.Primary Outcome
Title Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline temperature assessment.
Arm/Group Title Placebo Ibuprofen Sodium
Hide Arm/Group Description:
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: Degrees Fahrenheit
3.0  (6.3) 10.8  (4.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen Sodium
Comments Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95 percent (%) confidence interval (CI) were calculated based on Least-squares (LS) means from the Analysis of Variance (ANOVA) model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.228
Comments p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-squares (LS) mean difference
Estimated Value 8.33
Confidence Interval (2-Sided) 95%
-7.94 to 24.60
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.
Arm/Group Title Placebo Ibuprofen Sodium
Hide Arm/Group Description:
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: Degrees Fahrenheit
STEMPD 0-4 1.7  (3.9) 6.7  (2.9)
STEMPD 0-8 5.7  (9.4) 13.4  (7.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen Sodium
Comments STEMPD 0-4: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.171
Comments p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.99
Confidence Interval (2-Sided) 95%
-3.99 to 15.97
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen Sodium
Comments STEMPD 0-8: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.354
Comments p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 8.96
Confidence Interval (2-Sided) 95%
-14.78 to 32.69
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.
Arm/Group Title Placebo Ibuprofen Sodium
Hide Arm/Group Description:
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: Degrees Fahrenheit
0.25 hours 0.4  (0.4) 0.4  (0.3)
0.5 hours 0.5  (0.4) 0.7  (0.4)
1 hour 0.3  (0.7) 1.2  (0.7)
2 hours 0.8  (1.0) 1.9  (0.9)
4 hours 0.3  (1.5) 2.0  (0.9)
6 hours 0.7  (1.5) 2.1  (1.3)
8 hours 1.3  (1.7) 1.3  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen Sodium
Comments 0.25 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.576
Comments p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.84 to 0.54
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen Sodium
Comments 0.5 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.502
Comments p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.50 to 0.87
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen Sodium
Comments 1 hour: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.116
Comments p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
-0.51 to 3.12
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen Sodium
Comments 2 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.161
Comments p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.58
Confidence Interval (2-Sided) 95%
-0.98 to 4.14
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen Sodium
Comments 4 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.215
Comments p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.87
Confidence Interval (2-Sided) 95%
-1.66 to 5.41
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen Sodium
Comments 6 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.388
Comments p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
-2.18 to 4.52
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen Sodium
Comments 8 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.849
Comments p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
-3.98 to 4.61
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Treatment Failure
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.
Arm/Group Title Placebo Ibuprofen Sodium
Hide Arm/Group Description:
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
Overall Number of Participants Analyzed 7 9
Median (95% Confidence Interval)
Unit of Measure: hours
NA [1] 
(NA to NA)
NA [2] 
(NA to NA)
[1]
Data was not summarized, as median time to treatment failure for placebo group was greater than 8 hours (study duration) therefore 95% CI was not estimable.
[2]
Data was not summarized, as median time to treatment failure for ibuprofen sodium group was greater than 8 hours (study duration) therefore 95% CI was not estimable.
5.Secondary Outcome
Title Cumulative Percentage of Participants With Treatment Failure
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.
Arm/Group Title Placebo Ibuprofen Sodium
Hide Arm/Group Description:
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
Overall Number of Participants Analyzed 7 9
Measure Type: Number
Unit of Measure: percentage of participants
0.25 hours 0.0 0.0
0.5 hours 0.0 0.0
1 hour 0.0 0.0
2 hours 0.0 0.0
4 hours 0.0 0.0
6 hours 0.0 0.0
8 hours 0.0 11.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen Sodium
Comments 8 hours: Treatment difference (Ibuprofen sodium-Placebo) and its associated CI were calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportion and the corresponding standard errors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.378
Comments p-value was calculated using CMH general association test using table scores. Statistical testing was done at 5% significance level (2-sided).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in proportion
Estimated Value 11.11
Confidence Interval (2-Sided) 95%
-10.67 to 32.89
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Global Assessment of Study Medication as an Antipyretic
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.
Arm/Group Title Placebo Ibuprofen Sodium
Hide Arm/Group Description:
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.8  (1.5) 2.5  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen Sodium
Comments Treatment difference (Ibuprofen sodium-Placebo) and the associated CI were calculated based on the weighted Gamma statistic.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.324
Comments p-value was calculated using CMH test with modified ridit scores. Statistical testing was done at 5% significance level (2-sided).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
-0.30 to 1.27
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Rating of Study Medication Relative to Usual Medication
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.
Arm/Group Title Placebo Ibuprofen Sodium
Hide Arm/Group Description:
Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.5  (1.4) 2.4  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen Sodium
Comments Treatment difference (Ibuprofen sodium-Placebo) and the associated CI were calculated based on the weighted Gamma statistic.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.210
Comments p-value was calculated using CMH test with modified ridit scores. Statistical testing was done at 5% significance level (2-sided).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
-0.12 to 1.18
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Ibuprofen Sodium
Hide Arm/Group Description Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet. Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
All-Cause Mortality
Placebo Ibuprofen Sodium
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Ibuprofen Sodium
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Ibuprofen Sodium
Affected / at Risk (%) Affected / at Risk (%)
Total   1/7 (14.29%)   3/9 (33.33%) 
General disorders     
Cold sweat * 1  0/7 (0.00%)  1/9 (11.11%) 
Fatigue * 1  0/7 (0.00%)  1/9 (11.11%) 
Malaise * 1  0/7 (0.00%)  1/9 (11.11%) 
Pain * 1  1/7 (14.29%)  0/9 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain * 1  1/7 (14.29%)  0/9 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  0/7 (0.00%)  1/9 (11.11%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Definitive conclusion could not be made due to early termination of study, due to low enrollment rate, and small number of enrolled participants.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01035346     History of Changes
Other Study ID Numbers: AH-09-12
First Submitted: December 8, 2009
First Posted: December 18, 2009
Results First Submitted: July 13, 2012
Results First Posted: August 21, 2012
Last Update Posted: August 21, 2012