drugset / Trial / NCT02702778
Delayed Release Prednisone in PMR
Phase 2
Terminated
8 enrolled
Dinora, Inc.
Analgesic Solutions · collabPharPoint Research, Inc. · collab
RandomizedSingle-groupOpen-labelTreatment
Summary
A four-week, randomized, controlled, open-label trial of DR prednisone in which patients receive in period 1 one of three-night time doses of treatment (4mg, 7mg or 10mg) for two weeks followed in period 2 by treatment with 15mg IR prednisone in the morning for two weeks. Period 1 is randomized and open-label and period 2 is open label. Before enrollment and randomization patient diagnosis and responsiveness to 15mg IR prednisone in the morning is established. 45 patients will be randomized, 15 patients in each treatment arm.
Timeline
- Start
- 2016-02
- Primary completion
- 2016-12-31
- Completion
- 2017-03-31
Outcome
Outcome not reported
Stopped (Enrollment): “lack of study recruitment”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Prednisone | Other / unclassified | 4 mg | Oral |
| Comparator | Prednisone | Other / unclassified | 7 mg | Oral |
| Comparator | Prednisone | Other / unclassified | 10 mg | Oral |
| Comparator | Prednisone | Other / unclassified | 15 mg | — |