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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01938144
Recruitment Status : Withdrawn
First Posted : September 10, 2013
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 4, 2013
First Posted Date  ICMJE September 10, 2013
Last Update Posted Date October 14, 2015
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
  • 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 [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2013)
Change from baseline in the sum of 4 of the most common cold and flu symptoms (runny nose, plugged nose, sneezing and head congestion), averaged over 3 days obtained from the Wisconsin Upper Respiratory Symptom Survey - 21 [ Time Frame: 3 Days ]
Change from baseline in the sum of 4 of the most common cold and flu symptoms (runny nose, plugged nose, sneezing and head congestion), averaged over 3 days obtained from the Wisconsin Upper Respiratory Symptom Survey - 21
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
  • Change from baseline in the sum of all 10 common cold and flu symptoms, averaged over the treatment period. [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 1 hours ]
    One Hour Assessment of Relief question following the first dose
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2013)
  • Change from baseline in the sum of all 10 symptoms, averaged over 3 days. [ Time Frame: 3 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.
  • AM assessment of symptom relief reflective over the past 12 hours. [ Time Frame: 12 hours ]
    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.
  • PM assessment of symptom relief reflective over the past 12 hours. [ Time Frame: 12 hours ]
    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. [ Time Frame: 60 min ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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