drugset / Trial / NCT02702778

Delayed Release Prednisone in PMR

NCT02702778 ↗

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

EvaluationDrugModalityDoseRoute
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 —