Trials / Completed
CompletedNCT03911401
Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis
A Multicenter, Randomized, Double-blind, Vehicle Controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% and 1% OPA-15406 Ointment to the Vehicle in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 251 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 2 Years – 14 Years
- Healthy volunteers
- Not accepted
Summary
To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in pediatric patients with Atopic Dermatitis (AD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 0.3% OPA-15406 | Twice daily |
| DRUG | 1% OPA-15406 | Twice daily |
| DRUG | Placebos | Twice daily |
Timeline
- Start date
- 2019-05-07
- Primary completion
- 2019-12-13
- Completion
- 2019-12-13
- First posted
- 2019-04-11
- Last updated
- 2021-01-25
- Results posted
- 2021-01-25
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03911401. Inclusion in this directory is not an endorsement.