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

Pfizer

Status and phase: Withdrawn; Phase 3

Conditions: Common Cold

Treatments: Drug: Advil Congestion Relief; Drug: Paracetamol; Drug: Advil Allergy and Congestion Relief

Study type: Interventional

Funder types: Industry

Identifiers

NCT01938144

U1111-1147-8736 (Other Identifier)

B3971002

Details and patient eligibility

About

This is a multicenter, prospective, randomized, double-blind, triple-dummy, parallel group, comparative, study designed to evaluate the efficacy of Ibuprofen (IBU) 200 mg/ Phenylephrine (PE) 10 mg and IBU 200 mg/ PE 10 mg/ Chlorpheniramine (CHLOR) 4 mg on the relief of symptoms of the common cold and flu. The reference product that the active treatments will be compared to is paracetamol (PARA) 500 mg.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

Treatment A

Experimental group

Description:

IBU 200 mg/ PE 10 mg

Treatment:

Drug: Advil Congestion Relief

Treatment B

Experimental group

Description:

IBU 200 mg/ PE 10 mg/CHLOR 4 mg

Treatment:

Drug: Advil Allergy and Congestion Relief

Treatment C

Active Comparator group

Description:

Acetaminophen 500 mg

Treatment:

Drug: Paracetamol