Clinical Trial: The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-Blind, Randomised, Placebo-Controlled, Parallelgroup, Single-Dose Study to Evaluate Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Ma

Brief Summary: This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group, single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza. Eligible participants will be randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a four-hour (hr) treatment phase. Each participant will be administered only once during each study period. Participants will use a questionnaire to record the symptom severity scores as described, as well as time.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Symptom Severity Assessment at 15 Minutes [ Time Frame: 15 minutes ]

    Symptom severity assessment was determined by Total Sum Score (TSS), TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.

    TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.

    Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 15 minutes post product use.

  • Symptom Severity Assessment at 30 Minutes [ Time Frame: 30 minutes ]

    Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.

    TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.

    Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 30 minutes post product use.

  • Symptom Severity Assessment at 1 Hour [ Time Frame: 1 hou

    Original Primary Outcome:

    • Symptom severity assessment at 15 minutes (mins) [ Time Frame: 15 mins ]
      Participants will self-assess symptom severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15 minutes post product administration, covering sore throat, headache, extremities pain, nasal congestion, sneezing, runny nose and cough. All symptom severity assessment values will be recorded in questionnaire.
    • Symptom severity assessment at 30 mins [ Time Frame: 30 mins ]
      Participants will self-assess symptom severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 30 minutes post product administration, covering sore throat, headache, extremities pain, nasal congestion, sneezing, runny nose and cough. All symptom severity assessment values will be recorded in questionnaire.
    • Symptom severity assessment at 1 hr [ Time Frame: 1 hr ]
      Participants will self-assess symptom severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 1 hour post product administration, covering sore throat, headache, extremities pain, nasal congestion, sneezing, runny nose and cough. All symptom severity assessment values will be recorded in questionnaire.
    • Symptom severity assessment at 2 hrs [ Time Frame: 2 hrs ]
      Participants will self-assess symptom severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 2 hours post product administration, covering sore t

      Current Secondary Outcome:

      • Global Assessment of Treatment [ Time Frame: 4 hours ]
        After completing the 4 hours symptom severity assessments, participants evaluated their treatment response on a 5-point scale by answering the question: "How well did the test medication control your symptoms?" (0-ineffective, 1-poor, 2-fair, 3-good, or 4-excellent).
      • Sore Throat Severity Assessment [ Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes ]
        Participants self-assessed sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sore throat severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
      • Headache Severity Assessment [ Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes ]
        Participants self-assessed headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All headache severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
      • Extremities Pain Severity Assessment [ Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes ]
        Participants self-assessed extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All extremities pain severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
      • Nasal Congestion Severity Assessment [ Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes ]
        Participants self-assessed nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All nasal congestion severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
      • Runny Nose Severity Assessment [ Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes ]
        Participants self-assessed runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All runny nose severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
      • Sneezing Severity Assessment [ Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes ]
        Participants self-assessed sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sneezing severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
      • Cough Severity Assessment [ Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes ]
        Participants self-assessed cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All cough severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
      • Body Temperature Reduction [ Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes ]
        Summary statistics for body temperature was presented at baseline and at 15, 30, 60, 120,180 and 240 minutes post treatment. Wilcoxon Rank Sum test was used to investigate if there are any significant treatment differences.


      Original Secondary Outcome:

      • Global Assessment of Treatment [ Time Frame: 4 hrs ]
        After completing the 4 hours symptom severity assessments, participants will evaluate their treatment response on a 5-point scale by answering the question: "How well did the test medication control your symptoms?" (0-ineffective, 1-poor, 2-fair, 3-good, or 4-excellent).
      • Sore throat severity assessment at 15 mins [ Time Frame: 15 mins ]
        Participants will self-assess sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15 mins post product administration. All sore throat severity assessment values will be recorded in questionnaire.
      • Sore throat severity assessment at 30 mins [ Time Frame: 30 mins ]
        Participants will self-assess sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 30 mins post product administration. All sore throat severity assessment values will be recorded in questionnaire.
      • Sore throat severity assessment at 1 hr [ Time Frame: 1 hr ]
        Participants will self-assess sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 1 hr post product administration. All sore throat severity assessment values will be recorded in questionnaire.
      • Sore throat severity assessment at 2 hrs [ Time Frame: 2 hrs ]
        Participants will self-assess sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 2 hrs post product administration. All sore throat severity assessment values will be recorded in questionnaire.
      • Sore throat severity assessment at 3 hrs [ Time Frame: 3 hrs ]
        Participants will self-assess sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 3 hrs post product administration. All sore throat severity assessment values will be recorded in questionnaire.
      • Sore throat severity assessment at 4 hrs [ Time Frame: 4 hrs ]
        Participants will self-assess sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 4 hrs post product administration. All sore throat severity assessment values will be recorded in questionnaire.
      • Headache severity assessment at 15 mins [ Time Frame: 15 mins ]
        Participants will self-assess headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15 mins post product administration. All headache severity assessment values will be recorded in questionnaire.
      • Headache severity assessment at 30 mins [ Time Frame: 30 mins ]
        Participants will self-assess headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 30 mins post product administration. All headache severity assessment values will be recorded in questionnaire.
      • Headache severity assessment at 1 hr [ Time Frame: 1 hr ]
        Participants will self-assess headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 1 hr post product administration. All headache severity assessment values will be recorded in questionnaire.
      • Headache severity assessment at 2 hrs [ Time Frame: 2 hrs ]
        Participants will self-assess headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 2 hrs post product administration. All headache severity assessment values will be recorded in questionnaire.
      • Headache severity assessment at 3 hrs [ Time Frame: 3 hrs ]
        Participants will self-assess headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 3 hrs post product administration. All headache severity assessment values will be recorded in questionnaire.
      • Headache severity assessment at 4 hrs [ Time Frame: 4 hrs ]
        Participants will self-assess headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 4 hrs post product administration. All headache severity assessment values will be recorded in questionnaire.
      • Extremities pain severity assessment at 15 mins [ Time Frame: 15 mins ]
        Participants will self-assess extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline a

        Information By: GlaxoSmithKline

        Dates:
        Date Received: September 18, 2014
        Date Started: January 2015
        Date Completion:
        Last Updated: August 2, 2016
        Last Verified: May 2016