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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Common Cold

Intervention: Test tablet (Drug); Placebo (Other)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

Primary outcome:

Symptom severity assessment at 15 minutes (mins)

Symptom severity assessment at 30 mins

Symptom severity assessment at 1 hr

Symptom severity assessment at 2 hrs

Symptom severity assessment at 3 hrs

Symptom severity assessment at 4 hrs

Secondary outcome:

Global assessment of treatment

Sore throat severity assessment at 15 mins

Sore throat severity assessment at 30 mins

Sore throat severity assessment at 1 hr

Sore throat severity assessment at 2 hrs

Sore throat severity assessment at 3 hrs

Sore throat severity assessment at 4 hrs

Headache severity assessment at 15 mins

Headache severity assessment at 30 mins

Headache severity assessment at 1 hr

Headache severity assessment at 2 hrs

Headache severity assessment at 3 hrs

Headache severity assessment at 4 hrs

Extremities pain severity assessment at 15 mins

Extremities pain severity assessment at 30 mins

Extremities pain severity assessment at 1 hr

Extremities pain severity assessment at 2 hrs

Extremities pain severity assessment at 3 hrs

Extremities pain severity assessment at 4 hrs

Nasal congestion severity assessment at 15 mins

Nasal congestion severity assessment at 30 mins

Nasal congestion severity assessment at 1 hr

Nasal congestion severity assessment at 2 hrs

Nasal congestion severity assessment at 3 hrs

Nasal congestion severity assessment at 4 hrs

Sneezing severity assessment at 15 mins

Sneezing severity assessment at 30 mins

Sneezing severity assessment at 1 hr

Sneezing severity assessment at 2 hrs

Sneezing severity assessment at 3 hrs

Sneezing severity assessment at 4 hrs

Runny nose severity assessment at 15 mins

Runny nose severity assessment at 30 mins

Runny nose severity assessment at 1 hr

Runny nose severity assessment at 2 hrs

Runny nose severity assessment at 3 hrs

Runny nose severity assessment at 4 hrs

Cough severity assessment at 15 mins

Cough severity assessment at 30 mins

Cough severity assessment at 1 hr

Cough severity assessment at 2 hrs

Cough severity assessment at 3 hrs

Cough severity assessment at 4 hrs

Body temperature reduction at 15 mins

Body temperature reduction at 30 mins

Body temperature reduction at 1 hr

Body temperature reduction at 2 hrs

Body temperature reduction at 3 hrs

Body temperature reduction at 4 hrs

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

GSK Investigational Site, Shanghai 200025, China

GSK Investigational Site, Shanghai 200120, China

Additional Information

Starting date: January 2015
Last updated: March 23, 2015

Page last updated: August 20, 2015

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