Trial Outcomes & Findings for Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection (NCT NCT01035346)

NCT ID: NCT01035346

Last Updated: 2012-08-21

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 16 participants
• Primary outcome timeframe: 0 to 6 hours
• Results posted on: 2012-08-21

Participant Flow

Participant milestones

Measure	Placebo Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.	Ibuprofen Sodium Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
Overall Study STARTED	7	9
Overall Study COMPLETED	7	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection

Baseline characteristics by cohort

Measure	Placebo n=7 Participants Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Ibuprofen Sodium n=9 Participants Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.	Total n=16 Participants Total of all reporting groups
Age Continuous	31.4 years STANDARD_DEVIATION 15.3 • n=5 Participants	37.3 years STANDARD_DEVIATION 17.9 • n=7 Participants	34.8 years STANDARD_DEVIATION 16.5 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Body Temperature	100.99 Degrees Fahrenheit STANDARD_DEVIATION 0.83 • n=5 Participants	100.58 Degrees Fahrenheit STANDARD_DEVIATION 0.66 • n=7 Participants	100.76 Degrees Fahrenheit STANDARD_DEVIATION 0.74 • n=5 Participants

PRIMARY outcome

Timeframe: 0 to 6 hours

Population: Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline temperature assessment.

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.

Outcome measures

Measure	Placebo n=7 Participants Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Ibuprofen Sodium n=9 Participants Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)	3.0 Degrees Fahrenheit Standard Deviation 6.3	10.8 Degrees Fahrenheit Standard Deviation 4.9

SECONDARY outcome

Timeframe: 0 to 4, 0 to 8 hours

Population: ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.

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.

Outcome measures

Measure	Placebo n=7 Participants Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Ibuprofen Sodium n=9 Participants Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
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	1.7 Degrees Fahrenheit Standard Deviation 3.9	6.7 Degrees Fahrenheit Standard Deviation 2.9
Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8) STEMPD 0-8	5.7 Degrees Fahrenheit Standard Deviation 9.4	13.4 Degrees Fahrenheit Standard Deviation 7.3

SECONDARY outcome

Timeframe: Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours

Population: ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.

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.

Outcome measures

Measure	Placebo n=7 Participants Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Ibuprofen Sodium n=9 Participants Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8 0.25 hours	0.4 Degrees Fahrenheit Standard Deviation 0.4	0.4 Degrees Fahrenheit Standard Deviation 0.3
Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8 0.5 hours	0.5 Degrees Fahrenheit Standard Deviation 0.4	0.7 Degrees Fahrenheit Standard Deviation 0.4
Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8 1 hour	0.3 Degrees Fahrenheit Standard Deviation 0.7	1.2 Degrees Fahrenheit Standard Deviation 0.7
Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8 2 hours	0.8 Degrees Fahrenheit Standard Deviation 1.0	1.9 Degrees Fahrenheit Standard Deviation 0.9
Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8 4 hours	0.3 Degrees Fahrenheit Standard Deviation 1.5	2.0 Degrees Fahrenheit Standard Deviation 0.9
Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8 6 hours	0.7 Degrees Fahrenheit Standard Deviation 1.5	2.1 Degrees Fahrenheit Standard Deviation 1.3
Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8 8 hours	1.3 Degrees Fahrenheit Standard Deviation 1.7	1.3 Degrees Fahrenheit Standard Deviation 1.9

SECONDARY outcome

Timeframe: 0 to 8 hours

Population: ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.

Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.

Outcome measures

Measure	Placebo n=7 Participants Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Ibuprofen Sodium n=9 Participants Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
Time to Treatment Failure	NA hours 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.	NA hours 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.

SECONDARY outcome

Timeframe: 0.25, 0.5, 1, 2, 4, 6, 8 hours

Population: ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.

Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.

Outcome measures

Measure	Placebo n=7 Participants Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Ibuprofen Sodium n=9 Participants Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
Cumulative Percentage of Participants With Treatment Failure 6 hours	0.0 percentage of participants	0.0 percentage of participants
Cumulative Percentage of Participants With Treatment Failure 0.25 hours	0.0 percentage of participants	0.0 percentage of participants
Cumulative Percentage of Participants With Treatment Failure 0.5 hours	0.0 percentage of participants	0.0 percentage of participants
Cumulative Percentage of Participants With Treatment Failure 1 hour	0.0 percentage of participants	0.0 percentage of participants
Cumulative Percentage of Participants With Treatment Failure 2 hours	0.0 percentage of participants	0.0 percentage of participants
Cumulative Percentage of Participants With Treatment Failure 4 hours	0.0 percentage of participants	0.0 percentage of participants
Cumulative Percentage of Participants With Treatment Failure 8 hours	0.0 percentage of participants	11.1 percentage of participants

SECONDARY outcome

Timeframe: 8 hours

Population: ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.

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.

Outcome measures

Measure	Placebo n=7 Participants Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Ibuprofen Sodium n=9 Participants Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
Global Assessment of Study Medication as an Antipyretic	1.8 units on a scale Standard Deviation 1.5	2.5 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 8 hours

Population: ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.

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.

Outcome measures

Measure	Placebo n=7 Participants Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Ibuprofen Sodium n=9 Participants Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
Rating of Study Medication Relative to Usual Medication	1.5 units on a scale Standard Deviation 1.4	2.4 units on a scale Standard Deviation 1.1

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ibuprofen Sodium

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=7 participants at risk Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.	Ibuprofen Sodium n=9 participants at risk Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
General disorders Cold sweat	0.00% 0/7	11.1% 1/9
General disorders Fatigue	0.00% 0/7	11.1% 1/9
General disorders Malaise	0.00% 0/7	11.1% 1/9
General disorders Pain	14.3% 1/7	0.00% 0/9
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	14.3% 1/7	0.00% 0/9
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/7	11.1% 1/9

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER