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

NCT01938144

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Common Cold
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Common Cold
Intervention  ICMJE
  • Drug: Advil Congestion Relief
    Orally adminstered, 200 mg Ibuprofen/10 mg Phenylephrine tablet, 4x/day, up to 8 doses.
  • Drug: Advil Allergy and Congestion Relief
    Orally adminstered, 200 mg Ibuprofen/10 mg Phenylephrine/4 mg Chlorpheniramine tablet, 4x/day, up to 8 doses.
  • Drug: Paracetamol
    Acetaminophen 500 mg, 4x/day, up to 8 doses.
Study Arms  ICMJE
  • Experimental: Treatment A
    IBU 200 mg/ PE 10 mg
    Intervention: Drug: Advil Congestion Relief
  • Experimental: Treatment B
    IBU 200 mg/ PE 10 mg/CHLOR 4 mg
    Intervention: Drug: Advil Allergy and Congestion Relief
  • Active Comparator: Treatment C
    Acetaminophen 500 mg
    Intervention: Drug: Paracetamol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 13, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2013)
750
Estimated Study Completion Date  ICMJE November 2016
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01938144
Other Study ID Numbers  ICMJE B3971002
U1111-1147-8736 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP