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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Common Cold
Interventions Drug: Test tablet
Other: Placebo
Enrollment 53
Recruitment Details The participants were recruited at 2 clinical sites in China
Pre-assignment Details  
Arm/Group Title Test Tablet Placebo
Hide Arm/Group Description Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg). Matching placebo tablet
Period Title: Overall Study
Started 26 27
Completed 25 27
Not Completed 1 0
Reason Not Completed
Protocol Violation             1             0
Arm/Group Title Test Tablet Placebo Total
Hide Arm/Group Description Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg). Matching placebo tablet Total of all reporting groups
Overall Number of Baseline Participants 25 27 52
Hide Baseline Analysis Population Description
Overall participants in the test arm were 25 as 1 participant data was not included in the baseline measure as he did not completed the study (Due to protocol deviation).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 27 participants 52 participants
37.8  (11.97) 38.5  (11.06) 38.2  (11.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
Female
21
  84.0%
19
  70.4%
40
  76.9%
Male
4
  16.0%
8
  29.6%
12
  23.1%
1.Primary Outcome
Title Symptom Severity Assessment at 15 Minutes
Hide Description

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.

Time Frame 15 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.
Arm/Group Title Test Tablet Placebo
Hide Arm/Group Description:
Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
Matching placebo tablet
Overall Number of Participants Analyzed 25 27
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Observed value 10.66  (0.309) 10.64  (0.304)
Change from baseline -1.11  (0.309) -1.13  (0.304)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Tablet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9473
Comments [Not Specified]
Method ANCOVA
Comments From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.77 to 0.83
Estimation Comments Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment
2.Primary Outcome
Title Symptom Severity Assessment at 30 Minutes
Hide Description

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.

Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for assessment of efficacy was the intent to treat (ITT) population. The intent-to-treat (ITT) population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.
Arm/Group Title Test Tablet Placebo
Hide Arm/Group Description:
Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
Matching placebo tablet
Overall Number of Participants Analyzed 25 27
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Observed value 9.55  (0.402) 9.74  (0.396)
Change from baseline -2.22  (0.402) -2.03  (0.396)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Tablet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7210
Comments [Not Specified]
Method ANCOVA
Comments From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-1.23 to 0.86
Estimation Comments Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatme
3.Primary Outcome
Title Symptom Severity Assessment at 1 Hour
Hide Description

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.

Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for assessment of efficacy was the intent to treat (ITT) population. The intent-to-treat (ITT) population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.
Arm/Group Title Test Tablet Placebo
Hide Arm/Group Description:
Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
Matching placebo tablet
Overall Number of Participants Analyzed 25 27
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Observed value 8.73  (0.495) 8.52  (0.487)
Change from baseline -3.04  (0.495) -3.25  (0.487)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Tablet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7445
Comments [Not Specified]
Method ANCOVA
Comments From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
-1.07 to 1.49
Estimation Comments [Not Specified]
4.Primary Outcome
Title Symptom Severity Assessment at 2 Hours
Hide Description

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.

Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.
Arm/Group Title Test Tablet Placebo
Hide Arm/Group Description:
Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
Matching placebo tablet
Overall Number of Participants Analyzed 25 27
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Observed value 7.54  (0.596) 7.31  (0.587)
Change from baseline -4.23  (0.596) -4.46  (0.587)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Tablet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7662
Comments [Not Specified]
Method ANCOVA
Comments From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
-1.32 to 1.78
Estimation Comments [Not Specified]
5.Primary Outcome
Title Symptom Severity Assessment at 3 Hours
Hide Description

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.

Time Frame 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.
Arm/Group Title Test Tablet Placebo
Hide Arm/Group Description:
Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
Matching placebo tablet
Overall Number of Participants Analyzed 25 27
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Observed value 6.80  (0.669) 6.25  (0.659)
Change from baseline -4.97  (0.669) -5.52  (0.659)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Tablet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5208
Comments [Not Specified]
Method ANCOVA
Comments From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
-1.18 to 2.29
Estimation Comments Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment
6.Primary Outcome
Title Symptom Severity Assessment at 4 Hours
Hide Description

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.

Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.
Arm/Group Title Test Tablet Placebo
Hide Arm/Group Description:
Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
Matching placebo tablet
Overall Number of Participants Analyzed 25 27
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Observed value 5.94  (0.702) 5.82  (0.692)
Change from baseline -5.83  (0.702) -5.95  (0.692)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Tablet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8993
Comments [Not Specified]
Method ANCOVA
Comments From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-1.71 to 1.94
Estimation Comments Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment
7.Secondary Outcome
Title Global Assessment of Treatment
Hide Description 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).
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.
Arm/Group Title Test Tablet Placebo
Hide Arm/Group Description:
Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
Matching placebo tablet
Overall Number of Participants Analyzed 25 27
Measure Type: Number
Unit of Measure: Participants
Ineffective (0) 1 2
Poor (1) 1 3
Fair (2) 9 3
Good (3) 10 17
Excellent (4) 4 2
8.Secondary Outcome
Title Sore Throat Severity Assessment
Hide Description 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.
Time Frame Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.
Arm/Group Title Test Tablet Placebo
Hide Arm/Group Description:
Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
Matching placebo tablet
Overall Number of Participants Analyzed 25 27
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Change from baseline in 15 minutes -0.12  (0.076) -0.28  (0.073)
Change from baseline in 30 minutes -0.21  (0.082) -0.29  (0.080)
Change from baseline in 60 minutes -0.27  (0.099) -0.29  (0.096)
Change from baseline in 120 minutes -0.33  (0.124) -0.49  (0.120)
Change from baseline in 180 minutes -0.33  (0.132) -0.53  (0.128)
Change from baseline in 240 minutes -0.46  (0.137) -0.71  (0.133)
9.Secondary Outcome
Title Headache Severity Assessment
Hide Description 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.
Time Frame Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.
Arm/Group Title Test Tablet Placebo
Hide Arm/Group Description:
Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
Matching placebo tablet
Overall Number of Participants Analyzed 25 27
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Change from baseline in 15 minutes -0.17  (0.094) -0.14  (0.090)
Change from baseline in 30 minutes -0.31  (0.113) -0.16  (0.108)
Change from baseline in 60 minutes -0.47  (0.130) -0.51  (0.123)
Change from baseline in 120 minutes -0.72  (0.123) -0.71  (0.117)
Change from baseline in 180 minutes -0.89  (0.130) -0.88  (0.123)
Change from baseline in 240 minutes -0.99  (0.125) -0.96  (0.118)
10.Secondary Outcome
Title Extremities Pain Severity Assessment
Hide Description 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.
Time Frame Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.
Arm/Group Title Test Tablet Placebo
Hide Arm/Group Description:
Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
Matching placebo tablet
Overall Number of Participants Analyzed 25 27
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Change from baseline in 15 minutes -0.21  (0.101) -0.10  (0.099)
Change from baseline in 30 minutes -0.22  (0.100) -0.19  (0.099)
Change from baseline in 60 minutes -0.32  (0.104) -0.32  (0.102)
Change from baseline in 120 minutes -0.47  (0.110) -0.46  (0.108)
Change from baseline in 180 minutes -0.58  (0.126) -0.57  (0.124)
Change from baseline in 240 minutes -0.64  (0.126) -0.60  (0.124)
11.Secondary Outcome
Title Nasal Congestion Severity Assessment
Hide Description 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.
Time Frame Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.
Arm/Group Title Test Tablet Placebo
Hide Arm/Group Description:
Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
Matching placebo tablet
Overall Number of Participants Analyzed 25 27
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Change from baseline in 15 minutes -0.32  (0.086) -0.31  (0.084)
Change from baseline in 30 minutes -0.59  (0.119) -0.60  (0.115)
Change from baseline in 60 minutes -0.61  (0.127) -0.68  (0.124)
Change from baseline in 120 minutes -0.91  (0.138) -1.02  (0.134)
Change from baseline in 180 minutes -1.04  (0.156) -1.14  (0.152)
Change from baseline in 240 minutes -1.19  (0.162) -1.20  (0.157)
12.Secondary Outcome
Title Runny Nose Severity Assessment
Hide Description 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.
Time Frame Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.
Arm/Group Title Test Tablet Placebo
Hide Arm/Group Description:
Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
Matching placebo tablet
Overall Number of Participants Analyzed 25 27
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Change from baseline in 15 minutes -0.20  (0.081) -0.18  (0.080)
Change from baseline in 30 minutes -0.48  (0.116) -0.32  (0.114)
Change from baseline in 60 minutes -0.54  (0.145) -0.61  (0.143)
Change from baseline in 120 minutes -0.78  (0.148) -0.65  (0.146)
Change from baseline in 180 minutes -0.89  (0.161) -0.98  (0.159)
Change from baseline in 240 minutes -1.12  (0.149) -0.97  (0.147)
13.Secondary Outcome
Title Sneezing Severity Assessment
Hide Description 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.
Time Frame Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.
Arm/Group Title Test Tablet Placebo
Hide Arm/Group Description:
Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
Matching placebo tablet
Overall Number of Participants Analyzed 25 27
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Change from baseline in 15 minutes -0.10  (0.089) -0.24  (0.088)
Change from baseline in 30 minutes -0.25  (0.103) -0.42  (0.102)
Change from baseline in 60 minutes -0.50  (0.126) -0.80  (0.124)
Change from baseline in 120 minutes -0.67  (0.138) -0.86  (0.136)
Change from baseline in 180 minutes -0.83  (0.138) -1.03  (0.136)
Change from baseline in 240 minutes -0.88  (0.135) -1.11  (0.133)
14.Secondary Outcome
Title Cough Severity Assessment
Hide Description 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.
Time Frame Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.
Arm/Group Title Test Tablet Placebo
Hide Arm/Group Description:
Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
Matching placebo tablet
Overall Number of Participants Analyzed 25 27
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Change from baseline in 15 minutes -0.11  (0.071) -0.06  (0.078)
Change from baseline in 30 minutes -0.28  (0.077) -0.25  (0.084)
Change from baseline in 60 minutes -0.49  (0.116) -0.33  (0.126)
Change from baseline in 120 minutes -0.51  (0.109) -0.45  (0.119)
Change from baseline in 180 minutes -0.53  (0.116) -0.53  (0.127)
Change from baseline in 240 minutes -0.72  (0.131) -0.59  (0.143)
15.Secondary Outcome
Title Body Temperature Reduction
Hide Description 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.
Time Frame Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.
Arm/Group Title Test Tablet Placebo
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Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
Matching placebo tablet
Overall Number of Participants Analyzed 25 27
Least Squares Mean (Standard Error)
Unit of Measure: °C (degree Celsius)
Change from baseline to 15 minutes -0.02  (0.070) 0.01  (0.047)
Change from baseline to 30 minutes -0.03  (0.080) -0.01  (0.071)
Change from baseline to 60 minutes -0.04  (0.081) 0.01  (0.049)
Change from baseline to 120 minutes -0.09  (0.079) -0.04  (0.065)
Change from baseline to 180 minutes -0.14  (0.060) -0.09  (0.067)
Change from baseline to 240 minutes -0.08  (0.058) -0.11  (0.066)
Time Frame AEs were collected from the start of the study until 5 days following last administration of the investigational product
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Tablet Placebo
Hide Arm/Group Description Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg). Matching placebo tablet
All-Cause Mortality
Test Tablet Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Test Tablet Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Test Tablet Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/25 (4.00%)      3/27 (11.11%)    
Gastrointestinal disorders     
GINGIVAL SWELLING   0/25 (0.00%)  0 1/27 (3.70%)  1
NAUSEA   0/25 (0.00%)  0 1/27 (3.70%)  1
Nervous system disorders     
DIZZINESS   0/25 (0.00%)  0 1/27 (3.70%)  1
SOMNOLENCE   1/25 (4.00%)  1 0/27 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02246166     History of Changes
Other Study ID Numbers: 202271
RH02565 ( Other Identifier: GSK )
First Submitted: September 18, 2014
First Posted: September 22, 2014
Results First Submitted: October 8, 2015
Results First Posted: June 21, 2016
Last Update Posted: September 14, 2016