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

NCT02761980 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: B5061002GEMINI IF
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fever

Keywords

ibuprofen; acetaminophen; induced fever; fever

Outcome Measures

Primary Outcomes (1)

• Time Weighted Sum of Temperature Difference (WSTD) From 0 to 8 Hours

  WSTD 0-8 was defined as time-weighted sum of temperature differences over 8 hours, weighted by time elapsed between each 2 consecutive time points post treatment (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours). Temperature difference was defined as baseline temperature (at 0 hour) minus the post-baseline temperature at each time point up to 8 hours (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours).

  0 to 8 hours post-dose

Secondary Outcomes (4)

• Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6

  0 to 2 hours postdose, 0 to 4 hours postdose, 0 to 6 hours postdose

• Time to Return to Normal Body Temperature

  Baseline (pre-dose) up to 8 hours post dose

• Time to Rescue Medication

  0 to 8 hours post dose

• Time Weighted Sum of Temperature Difference From 6 to 8 Hours

  6 to 8 hours postdose

Other Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (AEs)

  Baseline up to 24 hours after discharge (up to 32 hours)

Study Arms (4)

Ibuprofen 250 mg / Acetaminophen 500 mg

EXPERIMENTAL

Single dose of 2 caplets of Ibuprofen 125 mg / Acetaminophen 250 mg by mouth

Drug: Ibuprofen 250 mg / Acetaminophen 500 mg

Ibuprofen 250 mg

ACTIVE COMPARATOR

Single dose of 2 caplets of IBU 125 mg by mouth

Drug: Ibuprofen 250 mg

Acetaminophen 500 mg

ACTIVE COMPARATOR

Single dose of 1 APAP 500 mg caplet + 1 placebo caplet by mouth

Drug: Acetaminophen 500 mg

Placebo

PLACEBO COMPARATOR

Single dose of 2 caplets of Placebo by mouth

Drug: Placebo

Interventions

Ibuprofen 250 mg / Acetaminophen 500 mg DRUG

Ibuprofen 250 mg / Acetaminophen 500 mg

Also known as: IBU 250 / APAP 500

Ibuprofen 250 mg / Acetaminophen 500 mg

Ibuprofen 250 mg DRUG

Ibuprofen 250 mg

Also known as: IBU 250

Ibuprofen 250 mg

Acetaminophen 500 mg DRUG

1 APAP 500 mg caplet

Also known as: APAP 500

Acetaminophen 500 mg

Placebo DRUG

Placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• Body Mass Index (BMI) of 17.5 to 37.0 kg/m2; and a total body weight 50 kg (110 lbs) at Screening.
• The subject has demonstrably adequate veins, by visual inspection, for IV catheter insertion.

You may not qualify if:

• 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.
• 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.
• Subjects at risk for excessive bleeding.
• Subjects with a history of nasal polyps, angioedema, or significant or actively treated bronchospastic disease.
• 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.
• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Orleans Center for Clinical Research

Knoxville, Tennessee, 37920, United States

Location

Related Publications (1)

• 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.

  PMID: 34304913 DERIVED

Related Links

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

MeSH Terms

Conditions

Fever

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 4, 2016
• Study Start: December 6, 2016
• Primary Completion: December 6, 2017
• Study Completion: December 6, 2017
• Last Updated: December 7, 2018
• Results First Posted: December 7, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)