Trials / Completed
CompletedNCT03098823
A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLE
A Randomized, Double-Blind, Active Comparator-Controlled, Crossover Study to Assess the Capacity of RAYOS® Compared to Immediate-Release Prednisone to Improve Fatigue and Control Morning Symptoms in Subjects With Systemic Lupus Erythematosus
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Ampel BioSolutions, LLC · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
To compare the effect of RAYOS® versus immediate-release (IR) prednisone on fatigue as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RAYOS | FDA approved RAYOS for indication of fatigue in Lupus. |
| DRUG | Prednisone | FDA approved corticosteroid frequently used for SLE. |
Timeline
- Start date
- 2017-09-12
- Primary completion
- 2019-05-28
- Completion
- 2020-06-15
- First posted
- 2017-04-04
- Last updated
- 2020-07-08
Locations
21 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03098823. Inclusion in this directory is not an endorsement.