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

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ClinicalTrials.gov Identifier: NCT02246166
Recruitment Status : Completed
First Posted : September 22, 2014
Results First Posted : June 21, 2016
Last Update Posted : September 14, 2016
Sponsor:
Collaborator:
Sino-American Tianjin Smith Kline & French Laboratories Ltd
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE September 18, 2014
First Posted Date  ICMJE September 22, 2014
Results First Submitted Date  ICMJE October 8, 2015
Results First Posted Date  ICMJE June 21, 2016
Last Update Posted Date September 14, 2016
Study Start Date  ICMJE January 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2016)
  • 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 hour ]
    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 1hour post product use.
  • Symptom Severity Assessment at 2 Hours [ Time Frame: 2 hours ]
    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 2 hours post product use.
  • Symptom Severity Assessment at 3 Hours [ Time Frame: 3 hours ]
    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 3 hours post product use.
  • Symptom Severity Assessment at 4 Hours [ Time Frame: 4 hours ]
    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 4 hours post product use.
Original Primary Outcome Measures  ICMJE
 (submitted: September 18, 2014)
  • 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 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 3 hrs [ Time Frame: 3 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 3 hours 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 4 hrs [ Time Frame: 4 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 4 hours 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.
Change History Complete list of historical versions of study NCT02246166 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
  • 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 Measures  ICMJE
 (submitted: September 18, 2014)
  • 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 and at 15 mins post product administration. All extremities pain severity assessment values will be recorded in questionnaire.
  • Extremities pain severity assessment at 30 mins [ Time Frame: 30 mins ]
    Participants will self-assess extremities pain 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 extremities pain severity assessment values will be recorded in questionnaire.
  • Extremities pain severity assessment at 1 hr [ Time Frame: 1 hr ]
    Participants will self-assess extremities pain 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 extremities pain severity assessment values will be recorded in questionnaire.
  • Extremities pain severity assessment at 2 hrs [ Time Frame: 2 hrs ]
    Participants will self-assess extremities pain 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 extremities pain severity assessment values will be recorded in questionnaire.
  • Extremities pain severity assessment at 3 hrs [ Time Frame: 3 hrs ]
    Participants will self-assess extremities pain 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 extremities pain severity assessment values will be recorded in questionnaire.
  • Extremities pain severity assessment at 4 hrs [ Time Frame: 4 hrs ]
    Participants will self-assess extremities pain 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 extremities pain severity assessment values will be recorded in questionnaire.
  • Nasal congestion severity assessment at 15 mins [ Time Frame: 15 mins ]
    Participants will self-assess nasal congestion 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 nasal congestion severity assessment values will be recorded in questionnaire.
  • Nasal congestion severity assessment at 30 mins [ Time Frame: 30 mins ]
    Participants will self-assess nasal congestion 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 nasal congestion severity assessment values will be recorded in questionnaire.
  • Nasal congestion severity assessment at 1 hr [ Time Frame: 1 hr ]
    Participants will self-assess nasal congestion 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 nasal congestion severity assessment values will be recorded in questionnaire.
  • Nasal congestion severity assessment at 2 hrs [ Time Frame: 2 hrs ]
    Participants will self-assess nasal congestion 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 nasal congestion severity assessment values will be recorded in questionnaire.
  • Nasal congestion severity assessment at 3 hrs [ Time Frame: 3 hrs ]
    Participants will self-assess nasal congestion 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 nasal congestion severity assessment values will be recorded in questionnaire.
  • Nasal congestion severity assessment at 4 hrs [ Time Frame: 4 hrs ]
    Participants will self-assess nasal congestion 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 nasal congestion severity assessment values will be recorded in questionnaire.
  • Sneezing severity assessment at 15 mins [ Time Frame: 15 mins ]
    Participants will self-assess sneezing 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 sneezing severity assessment values will be recorded in questionnaire.
  • Sneezing severity assessment at 30 mins [ Time Frame: 30 mins ]
    Participants will self-assess sneezing 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 sneezing severity assessment values will be recorded in questionnaire.
  • Sneezing severity assessment at 1 hr [ Time Frame: 1 hr ]
    Participants will self-assess sneezing 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 sneezing severity assessment values will be recorded in questionnaire.
  • Sneezing severity assessment at 2 hrs [ Time Frame: 2 hrs ]
    Participants will self-assess sneezing 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 sneezing severity assessment values will be recorded in questionnaire.
  • Sneezing severity assessment at 3 hrs [ Time Frame: 3 hrs ]
    Participants will self-assess sneezing 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 sneezing severity assessment values will be recorded in questionnaire.
  • Sneezing severity assessment at 4 hrs [ Time Frame: 4 hrs ]
    Participants will self-assess sneezing 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 sneezing severity assessment values will be recorded in questionnaire.
  • Runny nose severity assessment at 15 mins [ Time Frame: 15 mins ]
    Participants will self-assess runny nose 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 runny nose severity assessment values will be recorded in questionnaire.
  • Runny nose severity assessment at 30 mins [ Time Frame: 30 mins ]
    Participants will self-assess runny nose 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 runny nose severity assessment values will be recorded in questionnaire.
  • Runny nose severity assessment at 1 hr [ Time Frame: 1 hr ]
    Participants will self-assess runny nose 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 runny nose severity assessment values will be recorded in questionnaire.
  • Runny nose severity assessment at 2 hrs [ Time Frame: 2 hrs ]
    Participants will self-assess runny nose 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 runny nose severity assessment values will be recorded in questionnaire.
  • Runny nose severity assessment at 3 hrs [ Time Frame: 3 hrs ]
    Participants will self-assess runny nose 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 runny nose severity assessment values will be recorded in questionnaire.
  • Runny nose severity assessment at 4 hrs [ Time Frame: 4 hrs ]
    Participants will self-assess runny nose 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 runny nose severity assessment values will be recorded in questionnaire.
  • Cough severity assessment at 15 mins [ Time Frame: 15 mins ]
    Participants will self-assess cough 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 cough severity assessment values will be recorded in questionnaire.
  • Cough severity assessment at 30 mins [ Time Frame: 30 mins ]
    Participants will self-assess cough 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 cough severity assessment values will be recorded in questionnaire.
  • Cough severity assessment at 1 hr [ Time Frame: 1 hr ]
    Participants will self-assess cough 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 cough severity assessment values will be recorded in questionnaire.
  • Cough severity assessment at 2 hrs [ Time Frame: 2 hrs ]
    Participants will self-assess cough 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 cough severity assessment values will be recorded in questionnaire.
  • Cough severity assessment at 3 hrs [ Time Frame: 3 hrs ]
    Participants will self-assess cough 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 cough severity assessment values will be recorded in questionnaire.
  • Cough severity assessment at 4 hrs [ Time Frame: 4 hrs ]
    Participants will self-assess cough 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 cough severity assessment values will be recorded in questionnaire.
  • Body temperature reduction at 15 mins [ Time Frame: 15 mins ]
    Summary statistics for body temperature will be presented by treatment at baseline and 15 mins. Wilcoxon Rank Sum test will be used to investigate if there are any significant treatment differences.
  • Body temperature reduction at 30 mins [ Time Frame: 30 mins ]
    Summary statistics for body temperature will be presented by treatment at baseline and 30 mins. Wilcoxon Rank Sum test will be used to investigate if there are any significant treatment differences.
  • Body temperature reduction at 1 hr [ Time Frame: 1 hr ]
    Summary statistics for body temperature will be presented by treatment at baseline and 1 hr. Wilcoxon Rank Sum test will be used to investigate if there are any significant treatment differences.
  • Body temperature reduction at 2 hrs [ Time Frame: 2 hrs ]
    Summary statistics for body temperature will be presented by treatment at baseline and 2 hrs. Wilcoxon Rank Sum test will be used to investigate if there are any significant treatment differences.
  • Body temperature reduction at 3 hrs [ Time Frame: 3 hrs ]
    Summary statistics for body temperature will be presented by treatment at baseline and 3 hrs. Wilcoxon Rank Sum test will be used to investigate if there are any significant treatment differences.
  • Body temperature reduction at 4 hrs [ Time Frame: 4 hrs ]
    Summary statistics for body temperature will be presented by treatment at baseline and 4 hrs. Wilcoxon Rank Sum test will be used to investigate if there are any significant treatment differences.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.
Official Title  ICMJE A Double-Blind, Randomised, Placebo-Controlled, Parallelgroup, Single-Dose Study to Evaluate Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza Over a 4 Hour Period
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Common Cold
Intervention  ICMJE
  • Drug: Test tablet
    The active tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity
  • Other: Placebo
    The placebo tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity
Study Arms  ICMJE
  • Experimental: Test tablet
    Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
    Intervention: Drug: Test tablet
  • Placebo Comparator: Placebo
    Matching placebo tablet
    Intervention: Other: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2015)
53
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2014)
50
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged at least 18 years and less than 65 years
  • Good general and mental health in the opinion of the investigator
  • Participants diagnosed with a common cold or flu and must have the following symptoms of at least "moderate" in intensity (≥ 2) at the screening visit (baseline), with a minimum total symptom score of 6:

    (i) At least one of pain symptoms: sore throat, headache, or extremities pain (ii) Mandatory: Nasal congestion (iii) At least one of catarrh symptoms: runny nose or sneezing

  • Onset of first symptoms of cold must have occurred within 48 hours of screening.

Exclusion Criteria:

  • Pregnant or breast feeding women
  • History of seasonal or perennial allergic rhinitis or acute, sub-chronic, or chronic cough due to any condition other than a common cold or flu, as determined by the investigator
  • Concurrent illness or medical history that is contraindicated or cautioned about in the drug label
  • Anatomical factors causing nasal congestion
  • Fever with body temperature >38.5°C at baseline
  • Have used any medication or herbal remedies to treat cold prior to screening (antibiotics in the last 7 days, antihistamines in the last 72 hours, analgesics or antipyretics in the last 24 hours, decongestant in the last 12 hours, antitussive, medicated lozenge or throat spray in the last 8 hours)
  • Any medication that has potential drug-drug interactions with study medications
  • Known or suspected intolerance or hypersensitivity to the study materials
  • Have a positive drug urine test or recent history (within the last 2 years) of alcohol or other substance abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02246166
Other Study ID Numbers  ICMJE 202271
RH02565 ( Other Identifier: GSK )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Sino-American Tianjin Smith Kline & French Laboratories Ltd
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date May 2016

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