The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Collaborator: Sino-American Tianjin Smith Kline & French Laboratories Ltd
• Treatments: Acetaminophen; Chlorpheniramine; Dextromethorphan; Ephedrine; Maleic acid; Pseudoephedrine

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