Status:
COMPLETED
The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Sino-American Tianjin Smith Kline & French Laboratories Ltd
Conditions:
Common Cold
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 participan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT02246166
Start Date
January 1 2015
End Date
February 1 2015
Last Update
September 14 2016
Active Locations (2)
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1
GSK Investigational Site
Shanghai, China, 200025
2
GSK Investigational Site
Shanghai, China, 200120