drugset / Trial / NCT02678234
An Efficacy and Safety Study of Theraflu Day Powder as Oral Solution for Cold and Flu
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to assess the short term efficacy of the Theraflu Aktiv powder for oral solution in the Russian population as compared to an untreated group to support the indication of "Short term relief of the symptoms of colds, chills and influenza, including mild to moderate pain, fever and nasal congestion".
Timeline
- Start
- 2017-02-01
- Primary completion
- 2017-04-01
- Completion
- 2017-04-01
Outcome
Outcome not reported
Stopped: “The clinical phase of the study (from FSFV to LSLV) was never initiated due to the sponsor's decision.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 500 mg | Oral |
| Subject | Phenylephrine | Small molecule | 10 mg | Oral |
| Subject | Vitamin C | Other / unclassified | 200 mg | Oral |