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

• ClinicalTrials.gov Identifier: NCT01035346
• Recruitment Status: Terminated
• First Posted: December 18, 2009
• Results First Posted: August 21, 2012
• Last Update Posted: August 21, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Infection	Drug: Ibuprofen; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation Of The Antipyretic Efficacy Of Ibuprofen Sodium Tablets In Subjects With An Uncomplicated Acute Infection
• Study Start Date: January 2010
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: May 2011

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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 ]
   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.
2. 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 ]
   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.
3. Time to Treatment Failure [ Time Frame: 0 to 8 hours ]
   Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.
4. Cumulative Percentage of Participants With Treatment Failure [ Time Frame: 0.25, 0.5, 1, 2, 4, 6, 8 hours ]
   Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.
5. Global Assessment of Study Medication as an Antipyretic [ Time Frame: 8 hours ]
   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.
6. Rating of Study Medication Relative to Usual Medication [ Time Frame: 8 hours ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01035346
• Other Study ID Numbers: AH-09-12
• First Posted: December 18, 2009
• Results First Posted: August 21, 2012
• Last Update Posted: August 21, 2012
• Last Verified: July 2012

Keywords provided by Pfizer:

Fever; antipyretic; uncomplicated acute viral infection; uncomplicated acute bacterial infections

Additional relevant MeSH terms:

Infections; Communicable Diseases; Disease Attributes; Pathologic Processes; Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action