A Study of Ibuprofen 250 mg / Acetaminophen 500 mg Comparing The Antipyretic Effects in Healthy Male Volunteers
NCT ID: NCT02761980
Last Updated: 2018-12-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
290 participants
INTERVENTIONAL
2016-12-06
2017-12-06
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ibuprofen 250 mg / Acetaminophen 500 mg
Single dose of 2 caplets of Ibuprofen 125 mg / Acetaminophen 250 mg by mouth
Ibuprofen 250 mg / Acetaminophen 500 mg
Ibuprofen 250 mg / Acetaminophen 500 mg
Ibuprofen 250 mg
Single dose of 2 caplets of IBU 125 mg by mouth
Ibuprofen 250 mg
Ibuprofen 250 mg
Acetaminophen 500 mg
Single dose of 1 APAP 500 mg caplet + 1 placebo caplet by mouth
Acetaminophen 500 mg
1 APAP 500 mg caplet
Placebo
Single dose of 2 caplets of Placebo by mouth
Placebo
Placebo tablet
Interventions
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Ibuprofen 250 mg / Acetaminophen 500 mg
Ibuprofen 250 mg / Acetaminophen 500 mg
Ibuprofen 250 mg
Ibuprofen 250 mg
Acetaminophen 500 mg
1 APAP 500 mg caplet
Placebo
Placebo tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The subject must have a normal, stable body temperature at Screening and on Day 0. If the subject's oral temperature is not between 97.4°F and 98.8°F, then 2 additional oral temperature readings will be obtained within a 30 minute period. These 3 consecutive temperature readings must be between 97.4°F and 98.8°F, with the highest value within 0.4°F of the lowest temperature value.
3. Body Mass Index (BMI) of 17.5 to 37.0 kg/m2; and a total body weight 50 kg (110 lbs) at Screening.
4. The subject has demonstrably adequate veins, by visual inspection, for IV catheter insertion.
Exclusion Criteria
2. Subjects with any gastrointestinal disorders (eg, gastrectomy, tracheostomy, esophageal surgeries, short gut syndrome, peptic ulcer disease, known or suspected obstructive disease, previous gastrointestinal surgery, felinization of the esophagus, hypomotility of the gastrointestinal track) that could affect the absorption, metabolism, or excretion of the study medication or affect the results of the ingestible thermometer.
3. Subjects at risk for excessive bleeding.
4. Subjects with a history of nasal polyps, angioedema, or significant or actively treated bronchospastic disease.
5. Screening supine blood pressure ≤90 or ≥140 mm Hg (systolic) or ≤50 or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure (BP) is ≤90 or ≥140 mm Hg (systolic) or ≤50 or ≥90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three consecutive BP values should be used to determine the subject's eligibility.
6. Screening supine 12 lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 msec at Screening and on Day 1 prior to RSE administration. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three consecutive QTc or QRS values should be used to determine the subject's eligibility.
7. The subject has a history of recurrent or acute or chronic infections of any type or any findings suggestive of occult infection, such as tuberculosis, sinusitis, urinary tract infection, respiratory tract or dental (abscess) infection, etc., or those with a positive QuantiFERON Tuberculosis, Hepatitis B surface antigen, Hepatitis C antibody, and/or Human immunodeficiency virus (HIV) test at Screening. Also excluded are subjects with frequent (more than 3 outbreaks per year), recurrent oral or genital herpes, recurrent herpes zoster, or any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study.
8. Subjects who have experienced cold/flu symptoms (ie, runny nose, cough, and/or fever) within 2 weeks prior to the first administration of study treatments.
9. Subjects with a reduction in heart rate to ≤50 beats per minute or deemed to be at high risk of syncope and/or hypotension per the clinical judgment of the investigator following a carotid sinus massage procedure.
18 Years
55 Years
MALE
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
Countries
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References
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Smith W, Leyva R, Kellstein D, Arthur E, Cruz-Rivera M. Efficacy of a Fixed-Dose Combination of Ibuprofen and Acetaminophen Compared With Individual Monocomponents in Adult Male Subjects With Endotoxin-Induced Fever: A Randomized Controlled Trial. Clin Ther. 2021 Jul;43(7):1213-1227. doi: 10.1016/j.clinthera.2021.05.004. Epub 2021 Jul 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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GEMINI IF
Identifier Type: OTHER
Identifier Source: secondary_id
B5061002
Identifier Type: -
Identifier Source: org_study_id