Clinical trial NCT02246166: The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.
Official title: A Double-Blind, Randomised, Placebo-Controlled, Parallelgroup, Single-Dose Study to Evaluate Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza Over a 4 Hour Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Common Cold
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Sino-American Tianjin Smith Kline & French Laboratories Ltd
First posted: 2014-09-22
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Symptom Severity Assessment at 15 Minutes
timeFrame: 15 minutes
measure: Symptom Severity Assessment at 30 Minutes
timeFrame: 30 minutes
measure: Symptom Severity Assessment at 1 Hour
timeFrame: 1 hour
measure: Symptom Severity Assessment at 2 Hours
timeFrame: 2 hours
measure: Symptom Severity Assessment at 3 Hours
timeFrame: 3 hours
measure: Symptom Severity Assessment at 4 Hours
timeFrame: 4 hours
Secondary outcomes:
measure: Global Assessment of Treatment
timeFrame: 4 hours
measure: Sore Throat Severity Assessment
timeFrame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
measure: Headache Severity Assessment
timeFrame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
measure: Extremities Pain Severity Assessment
timeFrame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
measure: Nasal Congestion Severity Assessment
timeFrame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
measure: Runny Nose Severity Assessment
timeFrame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
measure: Sneezing Severity Assessment
timeFrame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
measure: Cough Severity Assessment
timeFrame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
measure: Body Temperature Reduction
timeFrame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Other outcomes:
Locations:
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: