InfectionPhase 3NCT01035346

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

A Phase 3 study testing Ibuprofen in people with Infection, run by Pfizer at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 12 to 65 years
Conditions the study is for: Infection
What is being tested?: Ibuprofen
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 5 sitesUnited States
Study dates: Jan 2010to May 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Pfizer Investigational Site
Cypress, California, 90630
Pfizer Investigational Site
Omaha, Nebraska, 68144
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15241
Pfizer Investigational Site
Salt Lake City, Utah, 84124
Pfizer Investigational Site
Westlake Village, California, 91361

Other trials in United States

About this study

Official title: Evaluation Of The Antipyretic Efficacy Of Ibuprofen Sodium Tablets In Subjects With An Uncomplicated Acute Infection

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.

Conditions: Infection
Being tested: Ibuprofen, Placebo
Keywords: Fever, antipyretic, uncomplicated acute viral infection, uncomplicated acute bacterial infections
Medical subject headings: Infections, Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IbuprofenDrug
Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen)
PlaceboDrug
Single dose of a placebo

Study groups in NCT01035346
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: Ibuprofen
B	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 0 to 6 hours

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010May 2011

First posted18 Dec 2009 (estimated)
Study startJan 2010
Primary completionMay 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfectionStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01035346
Sponsor's protocol ID: AH-09-12
Status last verified: Jul 2012
First submitted: 8 Dec 2009
Last updated: 21 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 25526232

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation Of The Antipyretic Efficacy Of Ibuprofen Sodium Tablets In Subjects With An Uncomplicated Acute Infection
ClinicalTrials.gov ID: NCT01035346
Acronym / sponsor ID: AH-09-12
Conditions: Infection
Keywords: Fever, antipyretic, uncomplicated acute viral infection, uncomplicated acute bacterial infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 16 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 18 Dec 2009 (estimated)
Results: Posted 21 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: Ibuprofen
B	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 12 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IbuprofenSingle dose of a novel ibuprofen formulation (equal to 400mg ibuprofen)	Drug	A
PlaceboSingle dose of a placebo	Drug	B

Primary outcome

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.

6 secondary outcomes

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
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
Time to Treatment Failure
Time frame: 0 to 8 hours
Cumulative Percentage of Participants With Treatment Failure
Time frame: 0.25, 0.5, 1, 2, 4, 6, 8 hours
Global Assessment of Study Medication as an Antipyretic
Time frame: 8 hours
Rating of Study Medication Relative to Usual Medication
Time frame: 8 hours

Results and safety

Results posted to the registry on 21 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	7	7
Ibuprofen Sodium	9	9

Primary outcome: Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)

Time frame: 0 to 6 hours. Mean (Standard Deviation). Unit: Degrees Fahrenheit

Measure	Placebo n = 7	Ibuprofen Sodium n = 9
Value	3.0 (6.3)	10.8 (4.9)

Placebo vs Ibuprofen Sodium: Least-squares (LS) mean difference: 8.33 (95% CI -7.94 to 24.60), p = 0.228, ANOVA

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

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 7 (0%)	1 of 7 (14.3%)	Not reported
Ibuprofen Sodium	0 of 9 (0%)	3 of 9 (33.3%)	Not reported

Limitations and caveats (from the sponsor): Definitive conclusion could not be made due to early termination of study, due to low enrollment rate, and small number of enrolled participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25526232Jayawardena 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ibuprofen in people with Infection, run by Pfizer at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6) (time frame: 0 to 6 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01035346, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2012.