Common Cold
Conditions
Keywords
Common cold, efficacy, symptoms, Wisconsin Upper Respiratory Symptom Survey - 21, ibuprofen, phenylephrine, pseudoephedrine
Brief summary
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.
Interventions
DRUGAdvil Congestion Relief
Orally adminstered, 200 mg Ibuprofen/10 mg Phenylephrine tablet, 4x/day, up to 8 doses.
DRUGAdvil Allergy and Congestion Relief
Orally adminstered, 200 mg Ibuprofen/10 mg Phenylephrine/4 mg Chlorpheniramine tablet, 4x/day, up to 8 doses.
DRUGParacetamol
Acetaminophen 500 mg, 4x/day, up to 8 doses.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 2 Days | 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. |
| Symptom Survey - 21 | 2 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the sum of all 10 common cold and flu symptoms, averaged over the treatment period. | 2 Days | 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. |
| Change from baseline in the sum of 6 of the most common symptoms at each assessment (PM day 1, AM and PM day 2) | 2 Days | 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. |
| Symptom relief since taking the first dose | 1 hours | One Hour Assessment of Relief question following the first dose |
Outcome results
None listed