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A Study of Ibuprofen 250 mg / Acetaminophen 500 mg Comparing The Antipyretic (Fever Reduction) Effects in Healthy Male Volunteers

Last updated on October 11, 2018

FOR MORE INFORMATION
Study Location
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fever
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Healthy male subjects who, at the time of screening, are between 18 and 55 years of
age, inclusive.

2. The subject must have a normal, stable body temperature at Screening and on Day 0.

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Evidence or history of clinically significant laboratory abnormality, hematological,
renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (excluding untreated, asymptomatic, seasonal allergies at the time
of dosing) within the last 5 years that may increase the risk associated with study
participation.

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.

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.

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.

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.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Tablets
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes only
Duration
The time commitment for participation in the study.
Screening: Estimated 14 days
Follow up: Estimated 28 days
Treatment: Estimated 2 days
Site Visits
Screening: 1 visits
Follow up: visits
Treatment: 1 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Blood test
Electrocardiogram (ECG)
Physical examination
Urine test
Vital signs and measurements
Questionnaire
Other
NCT02761980
Pfizer
Completed
A Study of Ibuprofen 250 mg / Acetaminophen 500 mg Comparing The Antipyretic (Fever Reduction) Effects in Healthy Male Volunteers

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A Study of Ibuprofen 250 mg / Acetaminophen 500 mg Comparing The Antipyretic Effects in Healthy Male Volunteers
A Phase 3, Double-blind, Randomized, Placebo-controlled, Full Factorial, Safety And Efficacy Study Comparing The Antipyretic Effects Of A Single Oral Dose Of Ibuprofen (Ibu) 250 Mg/ Acetaminophen (Apap) 500 Mg Caplets To Ibu 250 Mg And Apap 500 Mg Caplets In Healthy Male Volunteers With Fever Induced By An Endotoxin
This is a single dose study that will evaluate the efficacy and safety of a Fixed Dose Combination Ibuprofen 250 mg/ Acetaminophen 500 mg tablet in healthy male patients with fever. Results for the Fixed Dose Combination product will be compared to the individual components Ibuprofen 250 mg and Acetaminophen 500 mg and also compared to placebo.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fever
  • Drug: Ibuprofen 250 mg / Acetaminophen 500 mg
    Ibuprofen 250 mg / Acetaminophen 500 mg
    Other Name: IBU 250 / APAP 500
  • Drug: Ibuprofen 250 mg
    Ibuprofen 250 mg
    Other Name: IBU 250
  • Drug: Acetaminophen 500 mg
    1 APAP 500 mg caplet
    Other Name: APAP 500
  • Drug: Placebo
    Placebo tablet
  • Experimental: Ibuprofen 250 mg / Acetaminophen 500 mg
    Single dose of 2 caplets of Ibuprofen 125 mg / Acetaminophen 250 mg by mouth
    Intervention: Drug: Ibuprofen 250 mg / Acetaminophen 500 mg
  • Active Comparator: Ibuprofen 250 mg
    Single dose of 2 caplets of IBU 125 mg by mouth
    Intervention: Drug: Ibuprofen 250 mg
  • Active Comparator: Acetaminophen 500 mg
    Single dose of 1 APAP 500 mg caplet + 1 placebo caplet by mouth
    Intervention: Drug: Acetaminophen 500 mg
  • Placebo Comparator: Placebo
    Single dose of 2 caplets of Placebo by mouth
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
290
December 26, 2017
December 26, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy male subjects who, at the time of screening, are between 18 and 55 years of age, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
  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:

  1. Evidence or history of clinically significant laboratory abnormality, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated, asymptomatic, seasonal allergies at the time of dosing) within the last 5 years that may increase the risk associated with study participation.
  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.
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
18 Years to 55 Years   (Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT02761980
B5061002
GEMINI IF ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...

URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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