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
Overview
- Phase
- Phase 4
- Intervention
- Test tablet
- Conditions
- Common Cold
- Sponsor
- GlaxoSmithKline
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Symptom Severity Assessment at 2 Hours
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Test tablet
Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
Intervention: Test tablet
Placebo
Matching placebo tablet
Intervention: Placebo
Outcomes
Primary Outcomes
Symptom Severity Assessment at 2 Hours
Time Frame: 2 hours
Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure. TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration. Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 2 hours post product use.
Symptom Severity Assessment at 15 Minutes
Time Frame: 15 minutes
Symptom severity assessment was determined by Total Sum Score (TSS), TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure. TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration. Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 15 minutes post product use.
Symptom Severity Assessment at 30 Minutes
Time Frame: 30 minutes
Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure. TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration. Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 30 minutes post product use.
Symptom Severity Assessment at 1 Hour
Time Frame: 1 hour
Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure. TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration. Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 1hour post product use.
Symptom Severity Assessment at 3 Hours
Time Frame: 3 hours
Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure. TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration. Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 3 hours post product use.
Symptom Severity Assessment at 4 Hours
Time Frame: 4 hours
Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure. TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration. Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 4 hours post product use.
Secondary Outcomes
- Runny Nose Severity Assessment(Change from baseline in 15, 30, 60,120, 180, and 240 minutes)
- Global Assessment of Treatment(4 hours)
- Extremities Pain Severity Assessment(Change from baseline in 15, 30, 60,120, 180, and 240 minutes)
- Nasal Congestion Severity Assessment(Change from baseline in 15, 30, 60,120, 180, and 240 minutes)
- Headache Severity Assessment(Change from baseline in 15, 30, 60,120, 180, and 240 minutes)
- Body Temperature Reduction(Change from baseline in 15, 30, 60,120, 180, and 240 minutes)
- Sore Throat Severity Assessment(Change from baseline in 15, 30, 60,120, 180, and 240 minutes)
- Cough Severity Assessment(Change from baseline in 15, 30, 60,120, 180, and 240 minutes)
- Sneezing Severity Assessment(Change from baseline in 15, 30, 60,120, 180, and 240 minutes)