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

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.

Timeline

Start

2015-01

Primary completion

2015-02

Completion

2015-02

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Test Tablet vs Placebo; p = 0.9473; Mean Difference (Final Values) 0.03 (95% CI -0.77 to 0.83); ANCOVA NCT02246166 ↗

Drugs

Indications