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

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NCT01035346

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Study Location
Pfizer Investigational Site
Cypress, California, 90630, United States
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Contact
1-800-718-1021
[email protected]
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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.

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Advanced Information
Descriptive Information
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
  • Drug: Ibuprofen
    Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen)
  • Drug: Placebo
    Single dose of a placebo
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Ibuprofen
  • Placebo Comparator: B
    Intervention: Drug: Placebo
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
 (submitted: July 13, 2012)		16
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2009)		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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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