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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Common Cold

Treatments: Drug: Test tablet; Other: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02246166

RH02565 (Other Identifier)

202271

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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53 participants in 2 patient groups, including a placebo group

Test tablet

Experimental group

Description:

Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).

Treatment:

Drug: Test tablet

Placebo

Placebo Comparator group

Description:

Matching placebo tablet

Treatment:

Other: Placebo