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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01035346
First received: December 8, 2009
Last updated: July 13, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Infection
Drug: Ibuprofen
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation Of The Antipyretic Efficacy Of Ibuprofen Sodium Tablets In Subjects With An Uncomplicated Acute Infection

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6) [ Time Frame: 0 to 6 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Time to Treatment Failure [ Time Frame: 0 to 8 hours ] [ Designated as safety issue: No ]
    Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.

  • Cumulative Percentage of Participants With Treatment Failure [ Time Frame: 0.25, 0.5, 1, 2, 4, 6, 8 hours ] [ Designated as safety issue: No ]
    Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.

  • Global Assessment of Study Medication as an Antipyretic [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    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.

  • Rating of Study Medication Relative to Usual Medication [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 16
Study Start Date: January 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Ibuprofen
Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen)
Placebo Comparator: B Drug: Placebo
Single dose of a placebo

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035346

Locations
United States, California
Pfizer Investigational Site
Cypress, California, United States, 90630
Pfizer Investigational Site
Westlake Village, California, United States, 91361
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68144
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01035346     History of Changes
Other Study ID Numbers: AH-09-12
Study First Received: December 8, 2009
Results First Received: July 13, 2012
Last Updated: July 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Fever
antipyretic
uncomplicated acute viral infection
uncomplicated acute bacterial infections

Additional relevant MeSH terms:
Communicable Diseases
Infection
Antipyretics
Ibuprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014