Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection
NCT01035346
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection | |||
Official Title ICMJE | Evaluation Of The Antipyretic Efficacy Of Ibuprofen Sodium Tablets In Subjects With An Uncomplicated Acute Infection | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Infection | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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. Epub 2014 Dec 15. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 16 | |||
Original Estimated Enrollment ICMJE | 90 | |||
Actual Study Completion Date ICMJE | May 2011 | |||
Actual Primary Completion Date | May 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years to 65 Years (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01035346 | |||
Other Study ID Numbers ICMJE | AH-09-12 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | July 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |