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

• ClinicalTrials.gov Identifier: NCT02246166
• Recruitment Status: Completed
• First Posted: September 22, 2014
• Results First Posted: June 21, 2016
• Last Update Posted: September 14, 2016
• Sponsor: GlaxoSmithKline
• Collaborator: Sino-American Tianjin Smith Kline & French Laboratories Ltd
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Common Cold	Drug: Test tablet; Other: Placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: January 2015
• Actual Primary Completion Date: February 2015
• Actual Study Completion Date: February 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Test tablet; Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).	Drug: Test tablet; The active tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity
Placebo Comparator: Placebo; Matching placebo tablet	Other: Placebo; The placebo tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity

Outcome Measures

Primary Outcome Measures :

1. Symptom Severity Assessment at 15 Minutes [ Time Frame: 15 minutes ]

   Symptom severity assessment was determined by Total Sum Score (TSS), TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.

   TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.

   Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 15 minutes post product use.

2. Symptom Severity Assessment at 30 Minutes [ Time Frame: 30 minutes ]

   Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.

   TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.

   Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 30 minutes post product use.

3. Symptom Severity Assessment at 1 Hour [ Time Frame: 1 hour ]

   Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.

   TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.

   Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 1hour post product use.

4. Symptom Severity Assessment at 2 Hours [ Time Frame: 2 hours ]

   Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.

   TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.

   Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 2 hours post product use.

5. Symptom Severity Assessment at 3 Hours [ Time Frame: 3 hours ]

   Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.

   TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.

   Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 3 hours post product use.

6. Symptom Severity Assessment at 4 Hours [ Time Frame: 4 hours ]

   Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.

   TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.

   Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 4 hours post product use.

Secondary Outcome Measures :

1. Global Assessment of Treatment [ Time Frame: 4 hours ]
   After completing the 4 hours symptom severity assessments, participants evaluated 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).
2. Sore Throat Severity Assessment [ Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes ]
   Participants self-assessed sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sore throat severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
3. Headache Severity Assessment [ Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes ]
   Participants self-assessed headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All headache severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
4. Extremities Pain Severity Assessment [ Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes ]
   Participants self-assessed extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All extremities pain severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
5. Nasal Congestion Severity Assessment [ Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes ]
   Participants self-assessed nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All nasal congestion severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
6. Runny Nose Severity Assessment [ Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes ]
   Participants self-assessed runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All runny nose severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
7. Sneezing Severity Assessment [ Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes ]
   Participants self-assessed sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sneezing severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
8. Cough Severity Assessment [ Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes ]
   Participants self-assessed cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All cough severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
9. Body Temperature Reduction [ Time Frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes ]
   Summary statistics for body temperature was presented at baseline and at 15, 30, 60, 120,180 and 240 minutes post treatment. Wilcoxon Rank Sum test was used to investigate if there are any significant treatment differences.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

China

GSK Investigational Site

Shanghai, China, 200025

GSK Investigational Site

Shanghai, China, 200120

Sponsors and Collaborators

GlaxoSmithKline

Sino-American Tianjin Smith Kline & French Laboratories Ltd

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02246166
• Other Study ID Numbers: 202271; RH02565 ( Other Identifier: GSK )
• First Posted: September 22, 2014
• Results First Posted: June 21, 2016
• Last Update Posted: September 14, 2016
• Last Verified: May 2016

Additional relevant MeSH terms:

Common Cold; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases