The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.
Condition: Common Cold
MeSH terms: Common Cold
Intervention: Test tablet; Placebo
Intervention description: The active tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity; The placebo tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

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