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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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NCT01035346

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Cypress, California, 90630 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01035346
Pfizer
Terminated
Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection

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Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Infection
  • Drug: Ibuprofen
    Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen)
  • Drug: Placebo
    Single dose of a placebo
  • Experimental: A
    Intervention: Drug: Ibuprofen
  • Placebo Comparator: B
    Intervention: Drug: Placebo
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.
 
Terminated
16
May 2011
May 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
12 Years to 65 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01035346
AH-09-12
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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