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

Common Cold Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246166
• Other study ID #: 202271
• Secondary ID: RH02565
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2014
• Last updated: March 23, 2015
• Start date: January 2015
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Cold

Intervention

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

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

Locations

Country	Name	City	State
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Sino-American Tianjin Smith Kline & French Laboratories Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom severity assessment at 15 minutes (mins)	Participants will self-assess symptom severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15 minutes post product administration, covering sore throat, headache, extremities pain, nasal congestion, sneezing, runny nose and cough. All symptom severity assessment values will be recorded in questionnaire.	15 mins	No
Primary	Symptom severity assessment at 30 mins	Participants will self-assess symptom severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 30 minutes post product administration, covering sore throat, headache, extremities pain, nasal congestion, sneezing, runny nose and cough. All symptom severity assessment values will be recorded in questionnaire.	30 mins	No
Primary	Symptom severity assessment at 1 hr	Participants will self-assess symptom severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 1 hour post product administration, covering sore throat, headache, extremities pain, nasal congestion, sneezing, runny nose and cough. All symptom severity assessment values will be recorded in questionnaire.	1 hr	No
Primary	Symptom severity assessment at 2 hrs	Participants will self-assess symptom severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 2 hours post product administration, covering sore throat, headache, extremities pain, nasal congestion, sneezing, runny nose and cough. All symptom severity assessment values will be recorded in questionnaire.	2 hrs	No
Primary	Symptom severity assessment at 3 hrs	Participants will self-assess symptom severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 3 hours post product administration, covering sore throat, headache, extremities pain, nasal congestion, sneezing, runny nose and cough. All symptom severity assessment values will be recorded in questionnaire.	3 hrs	No
Primary	Symptom severity assessment at 4 hrs	Participants will self-assess symptom severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 4 hours post product administration, covering sore throat, headache, extremities pain, nasal congestion, sneezing, runny nose and cough. All symptom severity assessment values will be recorded in questionnaire.	4 hrs	No
Secondary	Global assessment of treatment	After completing the 4 hours symptom severity assessments, participants will evaluate their treatment response on a 5-point scale by answering the question: "How well did the test medication control your symptoms?" (0-ineffective, 1-poor, 2-fair, 3-good, or 4-excellent).	4 hrs	No
Secondary	Sore throat severity assessment at 15 mins	Participants will self-assess sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15 mins post product administration. All sore throat severity assessment values will be recorded in questionnaire.	15 mins	No
Secondary	Sore throat severity assessment at 30 mins	Participants will self-assess sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 30 mins post product administration. All sore throat severity assessment values will be recorded in questionnaire.	30 mins	No
Secondary	Sore throat severity assessment at 1 hr	Participants will self-assess sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 1 hr post product administration. All sore throat severity assessment values will be recorded in questionnaire.	1 hr	No
Secondary	Sore throat severity assessment at 2 hrs	Participants will self-assess sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 2 hrs post product administration. All sore throat severity assessment values will be recorded in questionnaire.	2 hrs	No
Secondary	Sore throat severity assessment at 3 hrs	Participants will self-assess sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 3 hrs post product administration. All sore throat severity assessment values will be recorded in questionnaire.	3 hrs	No
Secondary	Sore throat severity assessment at 4 hrs	Participants will self-assess sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 4 hrs post product administration. All sore throat severity assessment values will be recorded in questionnaire.	4 hrs	No
Secondary	Headache severity assessment at 15 mins	Participants will self-assess headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15 mins post product administration. All headache severity assessment values will be recorded in questionnaire.	15 mins	No
Secondary	Headache severity assessment at 30 mins	Participants will self-assess headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 30 mins post product administration. All headache severity assessment values will be recorded in questionnaire.	30 mins	No
Secondary	Headache severity assessment at 1 hr	Participants will self-assess headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 1 hr post product administration. All headache severity assessment values will be recorded in questionnaire.	1 hr	No
Secondary	Headache severity assessment at 2 hrs	Participants will self-assess headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 2 hrs post product administration. All headache severity assessment values will be recorded in questionnaire.	2 hrs	No
Secondary	Headache severity assessment at 3 hrs	Participants will self-assess headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 3 hrs post product administration. All headache severity assessment values will be recorded in questionnaire.	3 hrs	No
Secondary	Headache severity assessment at 4 hrs	Participants will self-assess headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 4 hrs post product administration. All headache severity assessment values will be recorded in questionnaire.	4 hrs	No
Secondary	Extremities pain severity assessment at 15 mins	Participants will self-assess extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15 mins post product administration. All extremities pain severity assessment values will be recorded in questionnaire.	15 mins	No
Secondary	Extremities pain severity assessment at 30 mins	Participants will self-assess extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 30 mins post product administration. All extremities pain severity assessment values will be recorded in questionnaire.	30 mins	No
Secondary	Extremities pain severity assessment at 1 hr	Participants will self-assess extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 1 hr post product administration. All extremities pain severity assessment values will be recorded in questionnaire.	1 hr	No
Secondary	Extremities pain severity assessment at 2 hrs	Participants will self-assess extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 2 hrs post product administration. All extremities pain severity assessment values will be recorded in questionnaire.	2 hrs	No
Secondary	Extremities pain severity assessment at 3 hrs	Participants will self-assess extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 3 hrs post product administration. All extremities pain severity assessment values will be recorded in questionnaire.	3 hrs	No
Secondary	Extremities pain severity assessment at 4 hrs	Participants will self-assess extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 4 hrs post product administration. All extremities pain severity assessment values will be recorded in questionnaire.	4 hrs	No
Secondary	Nasal congestion severity assessment at 15 mins	Participants will self-assess nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15 mins post product administration. All nasal congestion severity assessment values will be recorded in questionnaire.	15 mins	No
Secondary	Nasal congestion severity assessment at 30 mins	Participants will self-assess nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 30 mins post product administration. All nasal congestion severity assessment values will be recorded in questionnaire.	30 mins	No
Secondary	Nasal congestion severity assessment at 1 hr	Participants will self-assess nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 1 hr post product administration. All nasal congestion severity assessment values will be recorded in questionnaire.	1 hr	No
Secondary	Nasal congestion severity assessment at 2 hrs	Participants will self-assess nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 2 hrs post product administration. All nasal congestion severity assessment values will be recorded in questionnaire.	2 hrs	No
Secondary	Nasal congestion severity assessment at 3 hrs	Participants will self-assess nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 3 hrs post product administration. All nasal congestion severity assessment values will be recorded in questionnaire.	3 hrs	No
Secondary	Nasal congestion severity assessment at 4 hrs	Participants will self-assess nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 4 hrs post product administration. All nasal congestion severity assessment values will be recorded in questionnaire.	4 hrs	No
Secondary	Sneezing severity assessment at 15 mins	Participants will self-assess sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15 mins post product administration. All sneezing severity assessment values will be recorded in questionnaire.	15 mins	No
Secondary	Sneezing severity assessment at 30 mins	Participants will self-assess sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 30 mins post product administration. All sneezing severity assessment values will be recorded in questionnaire.	30 mins	No
Secondary	Sneezing severity assessment at 1 hr	Participants will self-assess sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 1 hr post product administration. All sneezing severity assessment values will be recorded in questionnaire.	1 hr	No
Secondary	Sneezing severity assessment at 2 hrs	Participants will self-assess sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 2 hrs post product administration. All sneezing severity assessment values will be recorded in questionnaire.	2 hrs	No
Secondary	Sneezing severity assessment at 3 hrs	Participants will self-assess sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 3 hrs post product administration. All sneezing severity assessment values will be recorded in questionnaire.	3 hrs	No
Secondary	Sneezing severity assessment at 4 hrs	Participants will self-assess sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 4 hrs post product administration. All sneezing severity assessment values will be recorded in questionnaire.	4 hrs	No
Secondary	Runny nose severity assessment at 15 mins	Participants will self-assess runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15 mins post product administration. All runny nose severity assessment values will be recorded in questionnaire.	15 mins	No
Secondary	Runny nose severity assessment at 30 mins	Participants will self-assess runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 30 mins post product administration. All runny nose severity assessment values will be recorded in questionnaire.	30 mins	No
Secondary	Runny nose severity assessment at 1 hr	Participants will self-assess runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 1 hr post product administration. All runny nose severity assessment values will be recorded in questionnaire.	1 hr	No
Secondary	Runny nose severity assessment at 2 hrs	Participants will self-assess runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 2 hrs post product administration. All runny nose severity assessment values will be recorded in questionnaire.	2 hrs	No
Secondary	Runny nose severity assessment at 3 hrs	Participants will self-assess runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 3 hrs post product administration. All runny nose severity assessment values will be recorded in questionnaire.	3 hrs	No
Secondary	Runny nose severity assessment at 4 hrs	Participants will self-assess runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 4 hrs post product administration. All runny nose severity assessment values will be recorded in questionnaire.	4 hrs	No
Secondary	Cough severity assessment at 15 mins	Participants will self-assess cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15 mins post product administration. All cough severity assessment values will be recorded in questionnaire.	15 mins	No
Secondary	Cough severity assessment at 30 mins	Participants will self-assess cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 30 mins post product administration. All cough severity assessment values will be recorded in questionnaire.	30 mins	No
Secondary	Cough severity assessment at 1 hr	Participants will self-assess cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 1 hr post product administration. All cough severity assessment values will be recorded in questionnaire.	1 hr	No
Secondary	Cough severity assessment at 2 hrs	Participants will self-assess cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 2 hrs post product administration. All cough severity assessment values will be recorded in questionnaire.	2 hrs	No
Secondary	Cough severity assessment at 3 hrs	Participants will self-assess cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 3 hrs post product administration. All cough severity assessment values will be recorded in questionnaire.	3 hrs	No
Secondary	Cough severity assessment at 4 hrs	Participants will self-assess cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 4 hrs post product administration. All cough severity assessment values will be recorded in questionnaire.	4 hrs	No
Secondary	Body temperature reduction at 15 mins	Summary statistics for body temperature will be presented by treatment at baseline and 15 mins. Wilcoxon Rank Sum test will be used to investigate if there are any significant treatment differences.	15 mins	No
Secondary	Body temperature reduction at 30 mins	Summary statistics for body temperature will be presented by treatment at baseline and 30 mins. Wilcoxon Rank Sum test will be used to investigate if there are any significant treatment differences.	30 mins	No
Secondary	Body temperature reduction at 1 hr	Summary statistics for body temperature will be presented by treatment at baseline and 1 hr. Wilcoxon Rank Sum test will be used to investigate if there are any significant treatment differences.	1 hr	No
Secondary	Body temperature reduction at 2 hrs	Summary statistics for body temperature will be presented by treatment at baseline and 2 hrs. Wilcoxon Rank Sum test will be used to investigate if there are any significant treatment differences.	2 hrs	No
Secondary	Body temperature reduction at 3 hrs	Summary statistics for body temperature will be presented by treatment at baseline and 3 hrs. Wilcoxon Rank Sum test will be used to investigate if there are any significant treatment differences.	3 hrs	No
Secondary	Body temperature reduction at 4 hrs	Summary statistics for body temperature will be presented by treatment at baseline and 4 hrs. Wilcoxon Rank Sum test will be used to investigate if there are any significant treatment differences.	4 hrs	No