drugset / Trial / 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.
Phase 4
Completed
53 enrolled
GlaxoSmithKline
Sino-American Tianjin Smith Kline & French Laboratories Ltd · collab
RandomizedParallel-groupQuadruple-blindTreatment
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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 500 mg | Oral |
| Subject | Chlorpheniramine | Unknown | 2 mg | Oral |
| Subject | Dextromethorphan | Unknown | 15 mg | Oral |
| Subject | Pseudoephedrine | Small molecule | 30 mg | Oral |