A Phase 3 interventional study of Advil Congestion Relief and Advil Allergy and Congestion Relief in Common Cold, sponsored by Pfizer. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-14.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
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.
180 studies on the registry are indexed under Common Cold; 22 are open to participants now.
Browse Common Cold studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
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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:
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.
IBU 200 mg/ PE 10 mg
Drug: Advil Congestion Relief
IBU 200 mg/ PE 10 mg/CHLOR 4 mg
Drug: Advil Allergy and Congestion Relief
Acetaminophen 500 mg
Drug: Paracetamol
Orally adminstered, 200 mg Ibuprofen/10 mg Phenylephrine tablet, 4x/day, up to 8 doses.
Orally adminstered, 200 mg Ibuprofen/10 mg Phenylephrine/4 mg Chlorpheniramine tablet, 4x/day, up to 8 doses.
Acetaminophen 500 mg, 4x/day, up to 8 doses.
Change from baseline in the sum of 6 of the most common cold and flu symptoms (runny nose, plugged nose, sneezing, sore throat, scratchy throat, and head congestion), averaged over the treatment period assessed using the Wisconsin Upper Respiratory
The severity of cold/flu symptoms will be determined by the subject's response to the Wisconsin Upper Respiratory Symptom Survey, which includes questions related to the signs and symptoms of cold and flu, as well as Quality of Life Measures.
Time frame: 2 Days
Symptom Survey - 21
The severity of cold/flu symptoms will be determined by the subject's response to the Wisconsin Upper Respiratory Symptom Survey, which includes questions related to the signs and symptoms of cold and flu, as well as Quality of Life Measures.
Time frame: 2 Days
Change from baseline in the sum of all 10 common cold and flu symptoms, averaged over the treatment period.
The severity of cold/flu symptoms will be determined by the subject's response to the Wisconsin Upper Respiratory Symptom Survey, which includes questions related to the signs and symptoms of cold and flu, as well as Quality of Life Measures.
Time frame: 2 Days
Change from baseline in the sum of 6 of the most common symptoms at each assessment (PM day 1, AM and PM day 2)
The severity of cold/flu symptoms will be determined by the subject's response to the Wisconsin Upper Respiratory Symptom Survey, which includes questions related to the signs and symptoms of cold and flu, as well as Quality of Life Measures.
Time frame: 2 Days
Symptom relief since taking the first dose
One Hour Assessment of Relief question following the first dose
Time frame: 1 hours
No study locations are listed for this record.
This study is withdrawn, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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