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Evaluation of the Efficacy and Safety of Two Ibuprofen Combination Products for the Treatment of the Common Cold and Flu in Latin America

Last updated on February 22, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Common Cold
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Male and female subjects who are 18 years old or older at the time of screening.

Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.

Subjects must present with a score of 5 of higher for at least 2 of the following 6
symptoms: runny nose, plugged nose, sneezing, sore throat, scratchy throat, or head
congestion on the WURSS-21 assessment, within 36 hours of onset of symptoms.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Anyone with a history of chronic allergic rhinitis or asthma at the time of the screening
visit, or with history of chronic recurrent airway disease, infections, or frequent
complications of colds (otitis media, sinusitis, or bronchitis)

Subjects taking any prescription or non-prescription drug, within the last 7 days prior to
the screening, with which the administration of IBU, PE, CHLOR, or APAP is contraindicated,
may increase the risk associated with study participation, or may interfere with the
interpretation of study results, in the judgment of the Investigator.

Subjects currently taking a monoamine oxidase (MAO) inhibitor, or has taken an MAO
inhibitor within 2 months of screening.

Subjects currently taking a serotonin-selective reuptake inhibitor (SSRI), tricyclic
antidepressant (TCA), barbiturate, or any other neuroleptic, or has taken an SSRI, TCA,
barbiturate, or any other neuroleptic within 14 days of screening.

Subjects with a hypersensitivity to IBU, PE, or CHLOR or APAP.

NCT01938144
Pfizer
Withdrawn
Evaluation of the Efficacy and Safety of Two Ibuprofen Combination Products for the Treatment of the Common Cold and Flu in Latin America

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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