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

Common Cold Clinical Trial

Official title:

Three-day Clinical Evaluation Of The Efficacy And Safety Of Two Ibuprofen Combination Products For The Symptomatic Treatment Of The Common Cold And Flu: A Multicenter Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01938144
• Other study ID #: B3971002
• Secondary ID: U1111-1147-8736
• Status: Withdrawn
• Phase: Phase 3
• First received: September 4, 2013
• Last updated: October 13, 2015
• Start date: April 2016
• Est. completion date: November 2016

Study information

• Verified date: October 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Cold

Intervention

Drug:
• Advil Congestion Relief
Orally adminstered, 200 mg Ibuprofen/10 mg Phenylephrine tablet, 4x/day, up to 8 doses.
• Advil Allergy and Congestion Relief
Orally adminstered, 200 mg Ibuprofen/10 mg Phenylephrine/4 mg Chlorpheniramine tablet, 4x/day, up to 8 doses.
• Paracetamol
Acetaminophen 500 mg, 4x/day, up to 8 doses.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 Days	No
Primary	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.	2 Days	No
Secondary	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.	2 Days	No
Secondary	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.	2 Days	No
Secondary	Symptom relief since taking the first dose	One Hour Assessment of Relief question following the first dose	1 hours	No

External Links

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