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

NCT02246166 | Completed Phase 4 Results

• 2 other identifiers: 202271RH02565
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (6)

• Symptom Severity Assessment at 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.

  15 minutes

• Symptom Severity Assessment at 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.

  30 minutes

• Symptom Severity Assessment at 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.

  1 hour

• Symptom Severity Assessment at 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.

  2 hours

• Symptom Severity Assessment at 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.

  3 hours

• Symptom Severity Assessment at 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.

  4 hours

Secondary Outcomes (9)

• Global Assessment of Treatment

  4 hours

• Sore Throat Severity Assessment

  Change from baseline in 15, 30, 60,120, 180, and 240 minutes

• Headache Severity Assessment

  Change from baseline in 15, 30, 60,120, 180, and 240 minutes

• Extremities Pain Severity Assessment

  Change from baseline in 15, 30, 60,120, 180, and 240 minutes

• Nasal Congestion Severity Assessment

  Change from baseline in 15, 30, 60,120, 180, and 240 minutes

Study Arms (2)

Test tablet

EXPERIMENTAL

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

Drug: Test tablet

Placebo

PLACEBO COMPARATOR

Matching placebo tablet

Other: Placebo

Interventions

Test tablet DRUG

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

Test tablet

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Sino-American Tianjin Smith Kline & French Laboratories Ltd: collaborator

Study Sites (2)

GSK Investigational Site

Shanghai, 200025, China

Location

GSK Investigational Site

Shanghai, 200120, China

Location

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 22, 2014
• Study Start: January 1, 2015
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: September 14, 2016
• Results First Posted: June 21, 2016

Record last verified: 2016-05

Locations

CN (2)