CAPSTONE 2
Research type
Research Study
Full title
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
IRAS ID
216177
Contact name
Paul McEleny
Contact email
Sponsor organisation
Shionogi Ltd.
Eudract number
2016-002688-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
“Influenza” is a disease caused by the “influenza” infection, also known as the “flu”, which is transmitted primarily through airborne droplets. Unlike the common cold, flu usually causes a high fever, headache, a feeling of fever or chills, muscle or joint pain, a feeling of fatigue (tiredness), and respiratory symptoms such as cough, sore throat, and nasal congestion (stuffiness). Although illness with influenza generally is self-limiting, severe disease with fatal outcome can occur in both the otherwise healthy and in those with underlying comorbidities, which are at high risk of influenza complications.
The study medicine, S-033188, is an experimental medicine and has not yet been approved for sale or use in the United Kingdom. It is being studied to see if it is better at treating flu infections (“the flu”) in participants at high risk for complications and who have had flu symptoms for up to 48 hours before joining the study.
This study will see if S-033188 may work better than the current treatment (oseltamivir, Tamiflu®), or an inactive “dummy” also known as placebo treatment. It is hoped that in the case of the flu it will make the participant’s feel better more quickly.
This study will enrol 2157 eligible adult and adolescent participants at high risk for flu ages 12 and older.
This study is conducted in North America, Asia/Pacific, and European countries.
Participation in this study will last for approximately up to 22 days and will include at least 7 visits to the study site.
This study will enrol participants who developed flu symptoms within the last 48 hours, who are at high risk for complications from influenza.REC name
North East - York Research Ethics Committee
REC reference
17/NE/0009
Date of REC Opinion
10 Feb 2017
REC opinion
Further Information Favourable Opinion