Trials / Completed
CompletedNCT02949011
Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications
A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Patients With Influenza at High Risk of Influenza Complications
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,184 (actual)
- Sponsor
- Shionogi · Industry
- Sex
- All
- Age
- 12 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 improvement of influenza symptoms in patients with influenza presenting within 48 hours of symptom onset.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Baloxavir Marboxil | Tablets taken orally |
| DRUG | Placebo to Baloxavir Marboxil | Matching tablets taken orally |
| DRUG | Oseltamivir | Capsules taken orally |
| DRUG | Placebo to Oseltamivir | Matching placebo capsules taken orally |
Timeline
- Start date
- 2017-01-11
- Primary completion
- 2018-04-12
- Completion
- 2018-04-20
- First posted
- 2016-10-31
- Last updated
- 2019-11-19
- Results posted
- 2019-11-06
Source: ClinicalTrials.gov record NCT02949011. Inclusion in this directory is not an endorsement.