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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen) |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Cypress | California | 90630 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25526232 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet. |
| FG001 | Ibuprofen Sodium | Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet. |
| BG001 | Ibuprofen Sodium | Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline temperature assessment. | Posted | Mean | Standard Deviation | Degrees Fahrenheit | 0 to 6 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold sweat | General disorders | MedDRA 13.0 | Non-systematic Assessment |
Definitive conclusion could not be made due to early termination of study, due to low enrollment rate, and small number of enrolled participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
Single dose of a placebo |
|
| 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 |
| Westlake Village |
| California |
| 91361 |
| United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68144 | United States |
| Pfizer Investigational Site | Pittsburgh | Pennsylvania | 15241 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84124 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Temperature | Mean | Standard Deviation | Degrees Fahrenheit |
|
| Ibuprofen Sodium |
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen. |
|
|
|
| Secondary | 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. | ITT population included all randomized participants who received study medication and provided a baseline temperature assessment. | Posted | Mean | Standard Deviation | Degrees Fahrenheit | 0 to 4, 0 to 8 hours |
|
|
|
|
| Secondary | 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. | ITT population included all randomized participants who received study medication and provided a baseline temperature assessment. | Posted | Mean | Standard Deviation | Degrees Fahrenheit | Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours |
|
|
|
|
| Secondary | 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. | ITT population included all randomized participants who received study medication and provided a baseline temperature assessment. | Posted | Median | 95% Confidence Interval | hours | 0 to 8 hours |
|
|
|
| Secondary | Cumulative Percentage of Participants With Treatment Failure | Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication. | ITT population included all randomized participants who received study medication and provided a baseline temperature assessment. | Posted | Number | percentage of participants | 0.25, 0.5, 1, 2, 4, 6, 8 hours |
|
|
|
|
| Secondary | 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. | ITT population included all randomized participants who received study medication and provided a baseline temperature assessment. | Posted | Mean | Standard Deviation | units on a scale | 8 hours |
|
|
|
|
| Secondary | 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. | ITT population included all randomized participants who received study medication and provided a baseline temperature assessment. | Posted | Mean | Standard Deviation | units on a scale | 8 hours |
|
|
|
|
| 0 |
| 7 |
| 1 |
| 7 |
| EG001 | Ibuprofen Sodium | Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen. | 0 | 9 | 3 | 9 |
| Fatigue | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
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.
STEMPD 0-8: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. |
| ANOVA |
| 0.354 |
p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| 8.96 |
| 2-Sided |
| 95 |
| -14.78 |
| 32.69 |
| No |
| Superiority or Other |
| 1 hour |
|
| 2 hours |
|
| 4 hours |
|
| 6 hours |
|
| 8 hours |
|
0.5 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. |
| ANOVA |
| 0.502 |
p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| 0.18 |
| 2-Sided |
| 95 |
| -0.50 |
| 0.87 |
| No |
| Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.116 | p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.31 | 2-Sided | 95 | -0.51 | 3.12 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.161 | p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.58 | 2-Sided | 95 | -0.98 | 4.14 | No | Superiority or Other |
| 4 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.215 | p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.87 | 2-Sided | 95 | -1.66 | 5.41 | No | Superiority or Other |
| 6 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.388 | p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 1.17 | 2-Sided | 95 | -2.18 | 4.52 | No | Superiority or Other |
| 8 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.849 | p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.31 | 2-Sided | 95 | -3.98 | 4.61 | No | Superiority or Other |
| 1 hour |
|
| 2 hours |
|
| 4 hours |
|
| 6 hours |
|
| 8 hours |
|