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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

Primary Purpose

Common Cold

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Advil Congestion Relief
Advil Allergy and Congestion Relief
Paracetamol
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Cold focused on measuring Common cold, efficacy, symptoms, Wisconsin Upper Respiratory Symptom Survey - 21, ibuprofen, phenylephrine, pseudoephedrine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Treatment A

    Treatment B

    Treatment C

    Arm Description

    IBU 200 mg/ PE 10 mg

    IBU 200 mg/ PE 10 mg/CHLOR 4 mg

    Acetaminophen 500 mg

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    Symptom relief since taking the first dose
    One Hour Assessment of Relief question following the first dose

    Full Information

    First Posted
    September 4, 2013
    Last Updated
    October 13, 2015
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01938144
    Brief Title
    Evaluation of the Efficacy and Safety of Two Ibuprofen Combination Products for the Treatment of the Common Cold and Flu in Latin America
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    April 2016 (undefined)
    Primary Completion Date
    November 2016 (Anticipated)
    Study Completion Date
    November 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pfizer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Common Cold
    Keywords
    Common cold, efficacy, symptoms, Wisconsin Upper Respiratory Symptom Survey - 21, ibuprofen, phenylephrine, pseudoephedrine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment A
    Arm Type
    Experimental
    Arm Description
    IBU 200 mg/ PE 10 mg
    Arm Title
    Treatment B
    Arm Type
    Experimental
    Arm Description
    IBU 200 mg/ PE 10 mg/CHLOR 4 mg
    Arm Title
    Treatment C
    Arm Type
    Active Comparator
    Arm Description
    Acetaminophen 500 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Advil Congestion Relief
    Intervention Description
    Orally adminstered, 200 mg Ibuprofen/10 mg Phenylephrine tablet, 4x/day, up to 8 doses.
    Intervention Type
    Drug
    Intervention Name(s)
    Advil Allergy and Congestion Relief
    Intervention Description
    Orally adminstered, 200 mg Ibuprofen/10 mg Phenylephrine/4 mg Chlorpheniramine tablet, 4x/day, up to 8 doses.
    Intervention Type
    Drug
    Intervention Name(s)
    Paracetamol
    Intervention Description
    Acetaminophen 500 mg, 4x/day, up to 8 doses.
    Primary Outcome Measure Information:
    Title
    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
    Description
    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
    Title
    Symptom Survey - 21
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Change from baseline in the sum of all 10 common cold and flu symptoms, averaged over the treatment period.
    Description
    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
    Title
    Change from baseline in the sum of 6 of the most common symptoms at each assessment (PM day 1, AM and PM day 2)
    Description
    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
    Title
    Symptom relief since taking the first dose
    Description
    One Hour Assessment of Relief question following the first dose
    Time Frame
    1 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3971002&StudyName=Evaluation%20of%20the%20Efficacy%20and%20Safety%20of%20Two%20Ibuprofen%20Combination%20Products%20for%20the%20Treatment%20of%20the%20Common%20Cold%20and%20Flu%20in%20Latin%20
    Description
    To obtain contact information for a study center near you, click here.

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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

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