Common Cold
Conditions
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.
Interventions
DRUGTest tablet
The active tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity
OTHERPlacebo
The placebo tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity
Sponsors
Sino-American Tianjin Smith Kline & French Laboratories Ltd
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Severity Assessment at 15 Minutes | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sneezing Severity Assessment | 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. |
| Global Assessment of Treatment | 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). |
| Body Temperature Reduction | 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. |
| Cough Severity Assessment | 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. |
| Sore Throat Severity Assessment | 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 | 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 | 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 | 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 | 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. |
Countries
China
Participant flow
Recruitment details
The participants were recruited at 2 clinical sites in China
Participants by arm
| Arm | Count |
|---|---|
| Test Tablet Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg). | 25 |
| Placebo Matching placebo tablet | 27 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Test Tablet | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 37.8 Years STANDARD_DEVIATION 11.97 | 38.5 Years STANDARD_DEVIATION 11.06 | 38.2 Years STANDARD_DEVIATION 11.4 |
| Sex: Female, Male Female | 21 Participants | 19 Participants | 40 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 25 | 3 / 27 |
| serious Total, serious adverse events | 0 / 25 | 0 / 27 |
Outcome results
Primary
Symptom Severity Assessment at 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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Tablet | Symptom Severity Assessment at 15 Minutes | Observed value | 10.66 Score on scale | Standard Error 0.309 |
| Test Tablet | Symptom Severity Assessment at 15 Minutes | Change from baseline | -1.11 Score on scale | Standard Error 0.309 |
| Placebo | Symptom Severity Assessment at 15 Minutes | Observed value | 10.64 Score on scale | Standard Error 0.304 |
| Placebo | Symptom Severity Assessment at 15 Minutes | Change from baseline | -1.13 Score on scale | Standard Error 0.304 |
p-value: 0.947395% CI: [-0.77, 0.83]ANCOVA
Primary
Symptom Severity Assessment at 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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Tablet | Symptom Severity Assessment at 1 Hour | Observed value | 8.73 Score on scale | Standard Error 0.495 |
| Test Tablet | Symptom Severity Assessment at 1 Hour | Change from baseline | -3.04 Score on scale | Standard Error 0.495 |
| Placebo | Symptom Severity Assessment at 1 Hour | Observed value | 8.52 Score on scale | Standard Error 0.487 |
| Placebo | Symptom Severity Assessment at 1 Hour | Change from baseline | -3.25 Score on scale | Standard Error 0.487 |
p-value: 0.744595% CI: [-1.07, 1.49]ANCOVA
Primary
Symptom Severity Assessment at 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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Tablet | Symptom Severity Assessment at 2 Hours | Observed value | 7.54 Score on scale | Standard Error 0.596 |
| Test Tablet | Symptom Severity Assessment at 2 Hours | Change from baseline | -4.23 Score on scale | Standard Error 0.596 |
| Placebo | Symptom Severity Assessment at 2 Hours | Observed value | 7.31 Score on scale | Standard Error 0.587 |
| Placebo | Symptom Severity Assessment at 2 Hours | Change from baseline | -4.46 Score on scale | Standard Error 0.587 |
p-value: 0.766295% CI: [-1.32, 1.78]ANCOVA
Primary
Symptom Severity Assessment at 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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Tablet | Symptom Severity Assessment at 30 Minutes | Observed value | 9.55 Score on scale | Standard Error 0.402 |
| Test Tablet | Symptom Severity Assessment at 30 Minutes | Change from baseline | -2.22 Score on scale | Standard Error 0.402 |
| Placebo | Symptom Severity Assessment at 30 Minutes | Observed value | 9.74 Score on scale | Standard Error 0.396 |
| Placebo | Symptom Severity Assessment at 30 Minutes | Change from baseline | -2.03 Score on scale | Standard Error 0.396 |
p-value: 0.72195% CI: [-1.23, 0.86]ANCOVA
Primary
Symptom Severity Assessment at 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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Tablet | Symptom Severity Assessment at 3 Hours | Observed value | 6.80 Score on scale | Standard Error 0.669 |
| Test Tablet | Symptom Severity Assessment at 3 Hours | Change from baseline | -4.97 Score on scale | Standard Error 0.669 |
| Placebo | Symptom Severity Assessment at 3 Hours | Observed value | 6.25 Score on scale | Standard Error 0.659 |
| Placebo | Symptom Severity Assessment at 3 Hours | Change from baseline | -5.52 Score on scale | Standard Error 0.659 |
p-value: 0.520895% CI: [-1.18, 2.29]ANCOVA
Primary
Symptom Severity Assessment at 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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Tablet | Symptom Severity Assessment at 4 Hours | Observed value | 5.94 Score on scale | Standard Error 0.702 |
| Test Tablet | Symptom Severity Assessment at 4 Hours | Change from baseline | -5.83 Score on scale | Standard Error 0.702 |
| Placebo | Symptom Severity Assessment at 4 Hours | Observed value | 5.82 Score on scale | Standard Error 0.692 |
| Placebo | Symptom Severity Assessment at 4 Hours | Change from baseline | -5.95 Score on scale | Standard Error 0.692 |
p-value: 0.899395% CI: [-1.71, 1.94]ANCOVA
Secondary
Body Temperature Reduction
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
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Tablet | Body Temperature Reduction | Change from baseline to 15 minutes | -0.02 °C (degree Celsius) | Standard Error 0.07 |
| Test Tablet | Body Temperature Reduction | Change from baseline to 30 minutes | -0.03 °C (degree Celsius) | Standard Error 0.08 |
| Test Tablet | Body Temperature Reduction | Change from baseline to 60 minutes | -0.04 °C (degree Celsius) | Standard Error 0.081 |
| Test Tablet | Body Temperature Reduction | Change from baseline to 120 minutes | -0.09 °C (degree Celsius) | Standard Error 0.079 |
| Test Tablet | Body Temperature Reduction | Change from baseline to 180 minutes | -0.14 °C (degree Celsius) | Standard Error 0.06 |
| Test Tablet | Body Temperature Reduction | Change from baseline to 240 minutes | -0.08 °C (degree Celsius) | Standard Error 0.058 |
| Placebo | Body Temperature Reduction | Change from baseline to 180 minutes | -0.09 °C (degree Celsius) | Standard Error 0.067 |
| Placebo | Body Temperature Reduction | Change from baseline to 15 minutes | 0.01 °C (degree Celsius) | Standard Error 0.047 |
| Placebo | Body Temperature Reduction | Change from baseline to 120 minutes | -0.04 °C (degree Celsius) | Standard Error 0.065 |
| Placebo | Body Temperature Reduction | Change from baseline to 30 minutes | -0.01 °C (degree Celsius) | Standard Error 0.071 |
| Placebo | Body Temperature Reduction | Change from baseline to 240 minutes | -0.11 °C (degree Celsius) | Standard Error 0.066 |
| Placebo | Body Temperature Reduction | Change from baseline to 60 minutes | 0.01 °C (degree Celsius) | Standard Error 0.049 |
Secondary
Cough Severity Assessment
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
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Tablet | Cough Severity Assessment | Change from baseline in 15 minutes | -0.11 Score on scale | Standard Error 0.071 |
| Test Tablet | Cough Severity Assessment | Change from baseline in 30 minutes | -0.28 Score on scale | Standard Error 0.077 |
| Test Tablet | Cough Severity Assessment | Change from baseline in 60 minutes | -0.49 Score on scale | Standard Error 0.116 |
| Test Tablet | Cough Severity Assessment | Change from baseline in 120 minutes | -0.51 Score on scale | Standard Error 0.109 |
| Test Tablet | Cough Severity Assessment | Change from baseline in 180 minutes | -0.53 Score on scale | Standard Error 0.116 |
| Test Tablet | Cough Severity Assessment | Change from baseline in 240 minutes | -0.72 Score on scale | Standard Error 0.131 |
| Placebo | Cough Severity Assessment | Change from baseline in 180 minutes | -0.53 Score on scale | Standard Error 0.127 |
| Placebo | Cough Severity Assessment | Change from baseline in 15 minutes | -0.06 Score on scale | Standard Error 0.078 |
| Placebo | Cough Severity Assessment | Change from baseline in 120 minutes | -0.45 Score on scale | Standard Error 0.119 |
| Placebo | Cough Severity Assessment | Change from baseline in 30 minutes | -0.25 Score on scale | Standard Error 0.084 |
| Placebo | Cough Severity Assessment | Change from baseline in 240 minutes | -0.59 Score on scale | Standard Error 0.143 |
| Placebo | Cough Severity Assessment | Change from baseline in 60 minutes | -0.33 Score on scale | Standard Error 0.126 |
Secondary
Extremities Pain Severity Assessment
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
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Tablet | Extremities Pain Severity Assessment | Change from baseline in 15 minutes | -0.21 Score on scale | Standard Error 0.101 |
| Test Tablet | Extremities Pain Severity Assessment | Change from baseline in 30 minutes | -0.22 Score on scale | Standard Error 0.1 |
| Test Tablet | Extremities Pain Severity Assessment | Change from baseline in 60 minutes | -0.32 Score on scale | Standard Error 0.104 |
| Test Tablet | Extremities Pain Severity Assessment | Change from baseline in 120 minutes | -0.47 Score on scale | Standard Error 0.11 |
| Test Tablet | Extremities Pain Severity Assessment | Change from baseline in 180 minutes | -0.58 Score on scale | Standard Error 0.126 |
| Test Tablet | Extremities Pain Severity Assessment | Change from baseline in 240 minutes | -0.64 Score on scale | Standard Error 0.126 |
| Placebo | Extremities Pain Severity Assessment | Change from baseline in 180 minutes | -0.57 Score on scale | Standard Error 0.124 |
| Placebo | Extremities Pain Severity Assessment | Change from baseline in 15 minutes | -0.10 Score on scale | Standard Error 0.099 |
| Placebo | Extremities Pain Severity Assessment | Change from baseline in 120 minutes | -0.46 Score on scale | Standard Error 0.108 |
| Placebo | Extremities Pain Severity Assessment | Change from baseline in 30 minutes | -0.19 Score on scale | Standard Error 0.099 |
| Placebo | Extremities Pain Severity Assessment | Change from baseline in 240 minutes | -0.60 Score on scale | Standard Error 0.124 |
| Placebo | Extremities Pain Severity Assessment | Change from baseline in 60 minutes | -0.32 Score on scale | Standard Error 0.102 |
Secondary
Global Assessment of Treatment
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Tablet | Global Assessment of Treatment | Poor (1) | 1 Participants |
| Test Tablet | Global Assessment of Treatment | Good (3) | 10 Participants |
| Test Tablet | Global Assessment of Treatment | Fair (2) | 9 Participants |
| Test Tablet | Global Assessment of Treatment | Excellent (4) | 4 Participants |
| Test Tablet | Global Assessment of Treatment | Ineffective (0) | 1 Participants |
| Placebo | Global Assessment of Treatment | Excellent (4) | 2 Participants |
| Placebo | Global Assessment of Treatment | Ineffective (0) | 2 Participants |
| Placebo | Global Assessment of Treatment | Poor (1) | 3 Participants |
| Placebo | Global Assessment of Treatment | Fair (2) | 3 Participants |
| Placebo | Global Assessment of Treatment | Good (3) | 17 Participants |
Secondary
Headache Severity Assessment
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
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Tablet | Headache Severity Assessment | Change from baseline in 15 minutes | -0.17 Score on scale | Standard Error 0.094 |
| Test Tablet | Headache Severity Assessment | Change from baseline in 30 minutes | -0.31 Score on scale | Standard Error 0.113 |
| Test Tablet | Headache Severity Assessment | Change from baseline in 60 minutes | -0.47 Score on scale | Standard Error 0.13 |
| Test Tablet | Headache Severity Assessment | Change from baseline in 120 minutes | -0.72 Score on scale | Standard Error 0.123 |
| Test Tablet | Headache Severity Assessment | Change from baseline in 180 minutes | -0.89 Score on scale | Standard Error 0.13 |
| Test Tablet | Headache Severity Assessment | Change from baseline in 240 minutes | -0.99 Score on scale | Standard Error 0.125 |
| Placebo | Headache Severity Assessment | Change from baseline in 180 minutes | -0.88 Score on scale | Standard Error 0.123 |
| Placebo | Headache Severity Assessment | Change from baseline in 15 minutes | -0.14 Score on scale | Standard Error 0.09 |
| Placebo | Headache Severity Assessment | Change from baseline in 120 minutes | -0.71 Score on scale | Standard Error 0.117 |
| Placebo | Headache Severity Assessment | Change from baseline in 30 minutes | -0.16 Score on scale | Standard Error 0.108 |
| Placebo | Headache Severity Assessment | Change from baseline in 240 minutes | -0.96 Score on scale | Standard Error 0.118 |
| Placebo | Headache Severity Assessment | Change from baseline in 60 minutes | -0.51 Score on scale | Standard Error 0.123 |
Secondary
Nasal Congestion Severity Assessment
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
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Tablet | Nasal Congestion Severity Assessment | Change from baseline in 15 minutes | -0.32 Score on scale | Standard Error 0.086 |
| Test Tablet | Nasal Congestion Severity Assessment | Change from baseline in 30 minutes | -0.59 Score on scale | Standard Error 0.119 |
| Test Tablet | Nasal Congestion Severity Assessment | Change from baseline in 60 minutes | -0.61 Score on scale | Standard Error 0.127 |
| Test Tablet | Nasal Congestion Severity Assessment | Change from baseline in 120 minutes | -0.91 Score on scale | Standard Error 0.138 |
| Test Tablet | Nasal Congestion Severity Assessment | Change from baseline in 180 minutes | -1.04 Score on scale | Standard Error 0.156 |
| Test Tablet | Nasal Congestion Severity Assessment | Change from baseline in 240 minutes | -1.19 Score on scale | Standard Error 0.162 |
| Placebo | Nasal Congestion Severity Assessment | Change from baseline in 180 minutes | -1.14 Score on scale | Standard Error 0.152 |
| Placebo | Nasal Congestion Severity Assessment | Change from baseline in 15 minutes | -0.31 Score on scale | Standard Error 0.084 |
| Placebo | Nasal Congestion Severity Assessment | Change from baseline in 120 minutes | -1.02 Score on scale | Standard Error 0.134 |
| Placebo | Nasal Congestion Severity Assessment | Change from baseline in 30 minutes | -0.60 Score on scale | Standard Error 0.115 |
| Placebo | Nasal Congestion Severity Assessment | Change from baseline in 240 minutes | -1.20 Score on scale | Standard Error 0.157 |
| Placebo | Nasal Congestion Severity Assessment | Change from baseline in 60 minutes | -0.68 Score on scale | Standard Error 0.124 |
Secondary
Runny Nose Severity Assessment
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
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Tablet | Runny Nose Severity Assessment | Change from baseline in 15 minutes | -0.20 Score on scale | Standard Error 0.081 |
| Test Tablet | Runny Nose Severity Assessment | Change from baseline in 30 minutes | -0.48 Score on scale | Standard Error 0.116 |
| Test Tablet | Runny Nose Severity Assessment | Change from baseline in 60 minutes | -0.54 Score on scale | Standard Error 0.145 |
| Test Tablet | Runny Nose Severity Assessment | Change from baseline in 120 minutes | -0.78 Score on scale | Standard Error 0.148 |
| Test Tablet | Runny Nose Severity Assessment | Change from baseline in 180 minutes | -0.89 Score on scale | Standard Error 0.161 |
| Test Tablet | Runny Nose Severity Assessment | Change from baseline in 240 minutes | -1.12 Score on scale | Standard Error 0.149 |
| Placebo | Runny Nose Severity Assessment | Change from baseline in 180 minutes | -0.98 Score on scale | Standard Error 0.159 |
| Placebo | Runny Nose Severity Assessment | Change from baseline in 15 minutes | -0.18 Score on scale | Standard Error 0.08 |
| Placebo | Runny Nose Severity Assessment | Change from baseline in 120 minutes | -0.65 Score on scale | Standard Error 0.146 |
| Placebo | Runny Nose Severity Assessment | Change from baseline in 30 minutes | -0.32 Score on scale | Standard Error 0.114 |
| Placebo | Runny Nose Severity Assessment | Change from baseline in 240 minutes | -0.97 Score on scale | Standard Error 0.147 |
| Placebo | Runny Nose Severity Assessment | Change from baseline in 60 minutes | -0.61 Score on scale | Standard Error 0.143 |
Secondary
Sneezing Severity Assessment
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
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Tablet | Sneezing Severity Assessment | Change from baseline in 15 minutes | -0.10 Score on scale | Standard Error 0.089 |
| Test Tablet | Sneezing Severity Assessment | Change from baseline in 30 minutes | -0.25 Score on scale | Standard Error 0.103 |
| Test Tablet | Sneezing Severity Assessment | Change from baseline in 60 minutes | -0.50 Score on scale | Standard Error 0.126 |
| Test Tablet | Sneezing Severity Assessment | Change from baseline in 120 minutes | -0.67 Score on scale | Standard Error 0.138 |
| Test Tablet | Sneezing Severity Assessment | Change from baseline in 180 minutes | -0.83 Score on scale | Standard Error 0.138 |
| Test Tablet | Sneezing Severity Assessment | Change from baseline in 240 minutes | -0.88 Score on scale | Standard Error 0.135 |
| Placebo | Sneezing Severity Assessment | Change from baseline in 180 minutes | -1.03 Score on scale | Standard Error 0.136 |
| Placebo | Sneezing Severity Assessment | Change from baseline in 15 minutes | -0.24 Score on scale | Standard Error 0.088 |
| Placebo | Sneezing Severity Assessment | Change from baseline in 120 minutes | -0.86 Score on scale | Standard Error 0.136 |
| Placebo | Sneezing Severity Assessment | Change from baseline in 30 minutes | -0.42 Score on scale | Standard Error 0.102 |
| Placebo | Sneezing Severity Assessment | Change from baseline in 240 minutes | -1.11 Score on scale | Standard Error 0.133 |
| Placebo | Sneezing Severity Assessment | Change from baseline in 60 minutes | -0.80 Score on scale | Standard Error 0.124 |
Secondary
Sore Throat Severity Assessment
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
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Tablet | Sore Throat Severity Assessment | Change from baseline in 15 minutes | -0.12 Score on scale | Standard Error 0.076 |
| Test Tablet | Sore Throat Severity Assessment | Change from baseline in 30 minutes | -0.21 Score on scale | Standard Error 0.082 |
| Test Tablet | Sore Throat Severity Assessment | Change from baseline in 60 minutes | -0.27 Score on scale | Standard Error 0.099 |
| Test Tablet | Sore Throat Severity Assessment | Change from baseline in 120 minutes | -0.33 Score on scale | Standard Error 0.124 |
| Test Tablet | Sore Throat Severity Assessment | Change from baseline in 180 minutes | -0.33 Score on scale | Standard Error 0.132 |
| Test Tablet | Sore Throat Severity Assessment | Change from baseline in 240 minutes | -0.46 Score on scale | Standard Error 0.137 |
| Placebo | Sore Throat Severity Assessment | Change from baseline in 180 minutes | -0.53 Score on scale | Standard Error 0.128 |
| Placebo | Sore Throat Severity Assessment | Change from baseline in 15 minutes | -0.28 Score on scale | Standard Error 0.073 |
| Placebo | Sore Throat Severity Assessment | Change from baseline in 120 minutes | -0.49 Score on scale | Standard Error 0.12 |
| Placebo | Sore Throat Severity Assessment | Change from baseline in 30 minutes | -0.29 Score on scale | Standard Error 0.08 |
| Placebo | Sore Throat Severity Assessment | Change from baseline in 240 minutes | -0.71 Score on scale | Standard Error 0.133 |
| Placebo | Sore Throat Severity Assessment | Change from baseline in 60 minutes | -0.29 Score on scale | Standard Error 0.096 |