- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02246166
The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.
A Double-Blind, Randomised, Placebo-Controlled, Parallelgroup, Single-Dose Study to Evaluate Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza Over a 4 Hour Period
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Shanghai, China, 200025
- GSK Investigational Site
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Shanghai, China, 200120
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Matching placebo tablet
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The placebo tablet will be administered orally.
Product administration will occur within 30mins of the baseline assessment of symptom severity
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Experimental: Test tablet
Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
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The active tablet will be administered orally.
Product administration will occur within 30mins of the baseline assessment of symptom severity
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom Severity Assessment at 15 Minutes
Time Frame: 15 minutes
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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. |
15 minutes
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Symptom Severity Assessment at 30 Minutes
Time Frame: 30 minutes
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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. |
30 minutes
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Symptom Severity Assessment at 1 Hour
Time Frame: 1 hour
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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. |
1 hour
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Symptom Severity Assessment at 2 Hours
Time Frame: 2 hours
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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. |
2 hours
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Symptom Severity Assessment at 3 Hours
Time Frame: 3 hours
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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. |
3 hours
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Symptom Severity Assessment at 4 Hours
Time Frame: 4 hours
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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. |
4 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global Assessment of Treatment
Time Frame: 4 hours
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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).
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4 hours
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Sore Throat Severity Assessment
Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
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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.
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Change from baseline in 15, 30, 60,120, 180, and 240 minutes
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Headache Severity Assessment
Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
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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.
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Change from baseline in 15, 30, 60,120, 180, and 240 minutes
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Extremities Pain Severity Assessment
Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
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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.
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Change from baseline in 15, 30, 60,120, 180, and 240 minutes
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Nasal Congestion Severity Assessment
Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
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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.
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Change from baseline in 15, 30, 60,120, 180, and 240 minutes
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Runny Nose Severity Assessment
Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
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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.
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Change from baseline in 15, 30, 60,120, 180, and 240 minutes
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Sneezing Severity Assessment
Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
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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.
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Change from baseline in 15, 30, 60,120, 180, and 240 minutes
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Cough Severity Assessment
Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
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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.
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Change from baseline in 15, 30, 60,120, 180, and 240 minutes
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Body Temperature Reduction
Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
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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.
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Change from baseline in 15, 30, 60,120, 180, and 240 minutes
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202271
- RH02565 (Other Identifier: GSK)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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