Trials / Completed
CompletedNCT04322669
Study of Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI)
Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI), A Randomized, Double Blind, Placebo Controlled Clinical Trial (P-CRESCENT)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 338 (actual)
- Sponsor
- Almirall, S.A. · Industry
- Sex
- All
- Age
- 3 Years – 14 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the efficacy of pidotimod as treatment in participants with recurrent respiratory tract infections.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pidotimod | Participants will be randomized in ratio of 1:1 to receive Pidotimod 400 milligrams (mg), once daily (no infection present) or twice daily (infection present) orally up to Day 60 during the double-blind treatment period. |
| DRUG | Placebo | Participants will be randomized in ratio of 1:1 to receive placebo matched to Pidotimod, once daily (no infection present) or twice daily (infection present) orally up to Day 60 during the double-blind treatment period. |
Timeline
- Start date
- 2021-08-04
- Primary completion
- 2021-11-04
- Completion
- 2021-11-04
- First posted
- 2020-03-26
- Last updated
- 2022-02-02
Locations
16 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04322669. Inclusion in this directory is not an endorsement.