NCT02246166

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-09-22
• Last updated: 2016-09-14
• Results posted: 2016-06-21

Locations

2 sites across 1 country: China