At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Test tablet and Placebo for Common Cold. Completed, enrolled 53 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
The active tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity
The placebo tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity