Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection
This study has been terminated.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01035346
First received: December 8, 2009
Last updated: July 13, 2012
Last verified: July 2012
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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
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:
|
Antipyretics Ibuprofen Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013