Last updated: 11/03/2018 22:21:11
The effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering from the Common Cold or Influenza.
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Symptom severity assessment at 15 minutes
Timeframe: 15 minutes
Symptom severity assessment at 30 minutes
Timeframe: 30 minutes
Symptom severity assessment at 1 hour
Timeframe: 1 hour
Symptom severity assessment at 2 hours
Timeframe: 2 hours
Symptom severity assessment at 3 hours
Timeframe: 3 hours
Symptom severity assessment at 4 hours
Timeframe: 4 hours
Secondary outcomes:
Global assessment of treatment
Timeframe: 4 hours
Sore throat severity assessment
Timeframe: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Headache severity assessment
Timeframe: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Extremities pain severity assessment
Timeframe: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Nasal congestion severity assessment
Timeframe: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Runny nose severity assessment
Timeframe: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Sneezing severity assessment
Timeframe: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Cough severity assessment
Timeframe: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Body temperature reduction
Timeframe: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Interventions:
Drug: Test tablet
Other: Placebo
Enrollment:
53
Observational study model:
Not applicable
Primary completion date:
2015-16-02
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Common cold
Product
chlorphenamine, chlorphenamine/dextromethorphan/paracetamol/pseudoephedrine, dextromethorphan, paracetamol, pseudoephedrine
Collaborators
Sino-American Tianjin Smith Kline & French Laboratories Ltd
Study date(s)
January 2015 to February 2015
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Aged at least 18 years and less than 65 years
- Good general and mental health in the opinion of the investigator
- 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
Inclusion and exclusion 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
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2015-16-02
Actual study completion date
2015-16-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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