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

NCT ID: NCT02246166

Last Updated: 2016-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-02-28

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.

Conditions

Common Cold

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Test tablet

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

Group Type: EXPERIMENTAL

Test tablet

Intervention Type: DRUG

The active tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity

Placebo

Matching placebo tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

The placebo tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity

Interventions

Test tablet

The active tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity

Intervention Type: DRUG

Placebo

The placebo tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sino-American Tianjin Smith Kline & French Laboratories Ltd

UNKNOWN

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Shanghai, , China

Countries

China

Other Identifiers

RH02565

Identifier Type: OTHER

Identifier Source: secondary_id

202271

Identifier Type: -

Identifier Source: org_study_id