NCT02702778

Delayed Release Prednisone in PMR

A Randomized, Open-label, Dose-ranging Study of Oral Delayed Release Prednisone in Patients With Untreated Polymyalgia Rheumatic (PMR)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Dinora, Inc. · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polymyalgia Rheumatica

Interventions

Type	Name	Description
DRUG	Delayed-Release (DR) Prednisone	delayed release prednisone
DRUG	Immediate Release (IR) Prednisone	standard prednisone

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-12-31
• Completion: 2017-03-31
• First posted: 2016-03-09
• Last updated: 2017-05-03

Locations

6 sites across 1 country: United States