Trial Outcomes & Findings for The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza. (NCT NCT02246166)

NCT ID: NCT02246166

Last Updated: 2016-09-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 53 participants
• Primary outcome timeframe: 15 minutes
• Results posted on: 2016-09-14

Participant Flow

The participants were recruited at 2 clinical sites in China

Participant milestones

Measure	Test Tablet Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo Matching placebo tablet
Overall Study STARTED	26	27
Overall Study COMPLETED	25	27
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Test Tablet Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo Matching placebo tablet
Overall Study Protocol Violation	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Test Tablet n=25 Participants Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo n=27 Participants Matching placebo tablet	Total n=52 Participants Total of all reporting groups
Age, Continuous	37.8 Years STANDARD_DEVIATION 11.97 • n=5 Participants	38.5 Years STANDARD_DEVIATION 11.06 • n=7 Participants	38.2 Years STANDARD_DEVIATION 11.40 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes

Population: 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.

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.

Outcome measures

Measure	Test Tablet n=25 Participants Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo n=27 Participants Matching placebo tablet
Symptom Severity Assessment at 15 Minutes Observed value	10.66 Score on scale Standard Error 0.309	10.64 Score on scale Standard Error 0.304
Symptom Severity Assessment at 15 Minutes Change from baseline	-1.11 Score on scale Standard Error 0.309	-1.13 Score on scale Standard Error 0.304

PRIMARY outcome

Timeframe: 30 minutes

Population: 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.

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.

Outcome measures

Measure	Test Tablet n=25 Participants Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo n=27 Participants Matching placebo tablet
Symptom Severity Assessment at 30 Minutes Observed value	9.55 Score on scale Standard Error 0.402	9.74 Score on scale Standard Error 0.396
Symptom Severity Assessment at 30 Minutes Change from baseline	-2.22 Score on scale Standard Error 0.402	-2.03 Score on scale Standard Error 0.396

PRIMARY outcome

Timeframe: 1 hour

Population: 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.

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.

Outcome measures

Measure	Test Tablet n=25 Participants Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo n=27 Participants Matching placebo tablet
Symptom Severity Assessment at 1 Hour Observed value	8.73 Score on scale Standard Error 0.495	8.52 Score on scale Standard Error 0.487
Symptom Severity Assessment at 1 Hour Change from baseline	-3.04 Score on scale Standard Error 0.495	-3.25 Score on scale Standard Error 0.487

PRIMARY outcome

Timeframe: 2 hours

Population: 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.

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.

Outcome measures

Measure	Test Tablet n=25 Participants Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo n=27 Participants Matching placebo tablet
Symptom Severity Assessment at 2 Hours Observed value	7.54 Score on scale Standard Error 0.596	7.31 Score on scale Standard Error 0.587
Symptom Severity Assessment at 2 Hours Change from baseline	-4.23 Score on scale Standard Error 0.596	-4.46 Score on scale Standard Error 0.587

PRIMARY outcome

Timeframe: 3 hours

Population: 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.

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.

Outcome measures

Measure	Test Tablet n=25 Participants Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo n=27 Participants Matching placebo tablet
Symptom Severity Assessment at 3 Hours Observed value	6.80 Score on scale Standard Error 0.669	6.25 Score on scale Standard Error 0.659
Symptom Severity Assessment at 3 Hours Change from baseline	-4.97 Score on scale Standard Error 0.669	-5.52 Score on scale Standard Error 0.659

PRIMARY outcome

Timeframe: 4 hours

Population: 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.

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.

Outcome measures

Measure	Test Tablet n=25 Participants Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo n=27 Participants Matching placebo tablet
Symptom Severity Assessment at 4 Hours Observed value	5.94 Score on scale Standard Error 0.702	5.82 Score on scale Standard Error 0.692
Symptom Severity Assessment at 4 Hours Change from baseline	-5.83 Score on scale Standard Error 0.702	-5.95 Score on scale Standard Error 0.692

SECONDARY outcome

Timeframe: 4 hours

Population: 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.

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).

Outcome measures

Measure	Test Tablet n=25 Participants Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo n=27 Participants Matching placebo tablet
Global Assessment of Treatment Ineffective (0)	1 Participants	2 Participants
Global Assessment of Treatment Poor (1)	1 Participants	3 Participants
Global Assessment of Treatment Fair (2)	9 Participants	3 Participants
Global Assessment of Treatment Good (3)	10 Participants	17 Participants
Global Assessment of Treatment Excellent (4)	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Change from baseline in 15, 30, 60,120, 180, and 240 minutes

Population: 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.

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.

Outcome measures

Measure	Test Tablet n=25 Participants Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo n=27 Participants Matching placebo tablet
Sore Throat Severity Assessment Change from baseline in 240 minutes	-0.46 Score on scale Standard Error 0.137	-0.71 Score on scale Standard Error 0.133
Sore Throat Severity Assessment Change from baseline in 15 minutes	-0.12 Score on scale Standard Error 0.076	-0.28 Score on scale Standard Error 0.073
Sore Throat Severity Assessment Change from baseline in 30 minutes	-0.21 Score on scale Standard Error 0.082	-0.29 Score on scale Standard Error 0.080
Sore Throat Severity Assessment Change from baseline in 60 minutes	-0.27 Score on scale Standard Error 0.099	-0.29 Score on scale Standard Error 0.096
Sore Throat Severity Assessment Change from baseline in 120 minutes	-0.33 Score on scale Standard Error 0.124	-0.49 Score on scale Standard Error 0.120
Sore Throat Severity Assessment Change from baseline in 180 minutes	-0.33 Score on scale Standard Error 0.132	-0.53 Score on scale Standard Error 0.128

SECONDARY outcome

Timeframe: Change from baseline in 15, 30, 60,120, 180, and 240 minutes

Population: 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.

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.

Outcome measures

Measure	Test Tablet n=25 Participants Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo n=27 Participants Matching placebo tablet
Headache Severity Assessment Change from baseline in 15 minutes	-0.17 Score on scale Standard Error 0.094	-0.14 Score on scale Standard Error 0.090
Headache Severity Assessment Change from baseline in 30 minutes	-0.31 Score on scale Standard Error 0.113	-0.16 Score on scale Standard Error 0.108
Headache Severity Assessment Change from baseline in 60 minutes	-0.47 Score on scale Standard Error 0.130	-0.51 Score on scale Standard Error 0.123
Headache Severity Assessment Change from baseline in 120 minutes	-0.72 Score on scale Standard Error 0.123	-0.71 Score on scale Standard Error 0.117
Headache Severity Assessment Change from baseline in 180 minutes	-0.89 Score on scale Standard Error 0.130	-0.88 Score on scale Standard Error 0.123
Headache Severity Assessment Change from baseline in 240 minutes	-0.99 Score on scale Standard Error 0.125	-0.96 Score on scale Standard Error 0.118

SECONDARY outcome

Timeframe: Change from baseline in 15, 30, 60,120, 180, and 240 minutes

Population: 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.

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.

Outcome measures

Measure	Test Tablet n=25 Participants Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo n=27 Participants Matching placebo tablet
Extremities Pain Severity Assessment Change from baseline in 15 minutes	-0.21 Score on scale Standard Error 0.101	-0.10 Score on scale Standard Error 0.099
Extremities Pain Severity Assessment Change from baseline in 30 minutes	-0.22 Score on scale Standard Error 0.100	-0.19 Score on scale Standard Error 0.099
Extremities Pain Severity Assessment Change from baseline in 60 minutes	-0.32 Score on scale Standard Error 0.104	-0.32 Score on scale Standard Error 0.102
Extremities Pain Severity Assessment Change from baseline in 120 minutes	-0.47 Score on scale Standard Error 0.110	-0.46 Score on scale Standard Error 0.108
Extremities Pain Severity Assessment Change from baseline in 180 minutes	-0.58 Score on scale Standard Error 0.126	-0.57 Score on scale Standard Error 0.124
Extremities Pain Severity Assessment Change from baseline in 240 minutes	-0.64 Score on scale Standard Error 0.126	-0.60 Score on scale Standard Error 0.124

SECONDARY outcome

Timeframe: Change from baseline in 15, 30, 60,120, 180, and 240 minutes

Population: 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.

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.

Outcome measures

Measure	Test Tablet n=25 Participants Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo n=27 Participants Matching placebo tablet
Nasal Congestion Severity Assessment Change from baseline in 15 minutes	-0.32 Score on scale Standard Error 0.086	-0.31 Score on scale Standard Error 0.084
Nasal Congestion Severity Assessment Change from baseline in 30 minutes	-0.59 Score on scale Standard Error 0.119	-0.60 Score on scale Standard Error 0.115
Nasal Congestion Severity Assessment Change from baseline in 60 minutes	-0.61 Score on scale Standard Error 0.127	-0.68 Score on scale Standard Error 0.124
Nasal Congestion Severity Assessment Change from baseline in 120 minutes	-0.91 Score on scale Standard Error 0.138	-1.02 Score on scale Standard Error 0.134
Nasal Congestion Severity Assessment Change from baseline in 180 minutes	-1.04 Score on scale Standard Error 0.156	-1.14 Score on scale Standard Error 0.152
Nasal Congestion Severity Assessment Change from baseline in 240 minutes	-1.19 Score on scale Standard Error 0.162	-1.20 Score on scale Standard Error 0.157

SECONDARY outcome

Timeframe: Change from baseline in 15, 30, 60,120, 180, and 240 minutes

Population: 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.

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.

Outcome measures

Measure	Test Tablet n=25 Participants Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo n=27 Participants Matching placebo tablet
Runny Nose Severity Assessment Change from baseline in 15 minutes	-0.20 Score on scale Standard Error 0.081	-0.18 Score on scale Standard Error 0.080
Runny Nose Severity Assessment Change from baseline in 30 minutes	-0.48 Score on scale Standard Error 0.116	-0.32 Score on scale Standard Error 0.114
Runny Nose Severity Assessment Change from baseline in 60 minutes	-0.54 Score on scale Standard Error 0.145	-0.61 Score on scale Standard Error 0.143
Runny Nose Severity Assessment Change from baseline in 120 minutes	-0.78 Score on scale Standard Error 0.148	-0.65 Score on scale Standard Error 0.146
Runny Nose Severity Assessment Change from baseline in 180 minutes	-0.89 Score on scale Standard Error 0.161	-0.98 Score on scale Standard Error 0.159
Runny Nose Severity Assessment Change from baseline in 240 minutes	-1.12 Score on scale Standard Error 0.149	-0.97 Score on scale Standard Error 0.147

SECONDARY outcome

Timeframe: Change from baseline in 15, 30, 60,120, 180, and 240 minutes

Population: 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.

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.

Outcome measures

Measure	Test Tablet n=25 Participants Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo n=27 Participants Matching placebo tablet
Sneezing Severity Assessment Change from baseline in 15 minutes	-0.10 Score on scale Standard Error 0.089	-0.24 Score on scale Standard Error 0.088
Sneezing Severity Assessment Change from baseline in 30 minutes	-0.25 Score on scale Standard Error 0.103	-0.42 Score on scale Standard Error 0.102
Sneezing Severity Assessment Change from baseline in 60 minutes	-0.50 Score on scale Standard Error 0.126	-0.80 Score on scale Standard Error 0.124
Sneezing Severity Assessment Change from baseline in 120 minutes	-0.67 Score on scale Standard Error 0.138	-0.86 Score on scale Standard Error 0.136
Sneezing Severity Assessment Change from baseline in 180 minutes	-0.83 Score on scale Standard Error 0.138	-1.03 Score on scale Standard Error 0.136
Sneezing Severity Assessment Change from baseline in 240 minutes	-0.88 Score on scale Standard Error 0.135	-1.11 Score on scale Standard Error 0.133

SECONDARY outcome

Timeframe: Change from baseline in 15, 30, 60,120, 180, and 240 minutes

Population: 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.

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.

Outcome measures

Measure	Test Tablet n=25 Participants Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo n=27 Participants Matching placebo tablet
Cough Severity Assessment Change from baseline in 15 minutes	-0.11 Score on scale Standard Error 0.071	-0.06 Score on scale Standard Error 0.078
Cough Severity Assessment Change from baseline in 30 minutes	-0.28 Score on scale Standard Error 0.077	-0.25 Score on scale Standard Error 0.084
Cough Severity Assessment Change from baseline in 60 minutes	-0.49 Score on scale Standard Error 0.116	-0.33 Score on scale Standard Error 0.126
Cough Severity Assessment Change from baseline in 120 minutes	-0.51 Score on scale Standard Error 0.109	-0.45 Score on scale Standard Error 0.119
Cough Severity Assessment Change from baseline in 180 minutes	-0.53 Score on scale Standard Error 0.116	-0.53 Score on scale Standard Error 0.127
Cough Severity Assessment Change from baseline in 240 minutes	-0.72 Score on scale Standard Error 0.131	-0.59 Score on scale Standard Error 0.143

SECONDARY outcome

Timeframe: Change from baseline in 15, 30, 60,120, 180, and 240 minutes

Population: 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.

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.

Outcome measures

Measure	Test Tablet n=25 Participants Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo n=27 Participants Matching placebo tablet
Body Temperature Reduction Change from baseline to 15 minutes	-0.02 °C (degree Celsius) Standard Error 0.070	0.01 °C (degree Celsius) Standard Error 0.047
Body Temperature Reduction Change from baseline to 30 minutes	-0.03 °C (degree Celsius) Standard Error 0.080	-0.01 °C (degree Celsius) Standard Error 0.071
Body Temperature Reduction Change from baseline to 60 minutes	-0.04 °C (degree Celsius) Standard Error 0.081	0.01 °C (degree Celsius) Standard Error 0.049
Body Temperature Reduction Change from baseline to 120 minutes	-0.09 °C (degree Celsius) Standard Error 0.079	-0.04 °C (degree Celsius) Standard Error 0.065
Body Temperature Reduction Change from baseline to 180 minutes	-0.14 °C (degree Celsius) Standard Error 0.060	-0.09 °C (degree Celsius) Standard Error 0.067
Body Temperature Reduction Change from baseline to 240 minutes	-0.08 °C (degree Celsius) Standard Error 0.058	-0.11 °C (degree Celsius) Standard Error 0.066

Adverse Events

Test Tablet

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Test Tablet n=25 participants at risk Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Placebo n=27 participants at risk Matching placebo tablet
Gastrointestinal disorders GINGIVAL SWELLING	0.00% 0/25 • AEs were collected from the start of the study until 5 days following last administration of the investigational product	3.7% 1/27 • Number of events 1 • AEs were collected from the start of the study until 5 days following last administration of the investigational product
Gastrointestinal disorders NAUSEA	0.00% 0/25 • AEs were collected from the start of the study until 5 days following last administration of the investigational product	3.7% 1/27 • Number of events 1 • AEs were collected from the start of the study until 5 days following last administration of the investigational product
Nervous system disorders DIZZINESS	0.00% 0/25 • AEs were collected from the start of the study until 5 days following last administration of the investigational product	3.7% 1/27 • Number of events 1 • AEs were collected from the start of the study until 5 days following last administration of the investigational product
Nervous system disorders SOMNOLENCE	4.0% 1/25 • Number of events 1 • AEs were collected from the start of the study until 5 days following last administration of the investigational product	0.00% 0/27 • AEs were collected from the start of the study until 5 days following last administration of the investigational product

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER