Trials / Completed
CompletedNCT02954354
A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza
A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Otherwise Healthy Patients With Influenza
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,436 (actual)
- Sponsor
- Shionogi · Industry
- Sex
- All
- Age
- 12 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo by measuring the time to alleviation of symptoms in patients with uncomplicated influenza virus infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Baloxavir Marboxil | 2 to4 X 20-mg tablets taken orally |
| DRUG | Placebo to Baloxavir Marboxil | 2 to4 X 20-mg tablets taken orally |
| DRUG | Oseltamivir | 75 mg capsules taken orally |
| DRUG | Placebo to Oseltamivir | Placebo capsules matching oseltamivir 75 mg capsules |
Timeline
- Start date
- 2016-12-08
- Primary completion
- 2017-04-04
- Completion
- 2017-04-24
- First posted
- 2016-11-03
- Last updated
- 2019-05-08
- Results posted
- 2018-12-14
Source: ClinicalTrials.gov record NCT02954354. Inclusion in this directory is not an endorsement.