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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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 Stud

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 Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • 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: 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


Current Secondary Outcome:

  • 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:

  • 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 ]


Information By: Pfizer

Dates:
Date Received: September 4, 2013
Date Started: April 2016
Date Completion: November 2016
Last Updated: October 13, 2015
Last Verified: October 2015