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Delayed Release Prednisone in PMR

NCT02702778 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-05-03

No results posted yet for this study

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

DRUG

Delayed-Release (DR) Prednisone

delayed release prednisone

DRUG

Immediate Release (IR) Prednisone

standard prednisone

Sponsors & Collaborators

  • Analgesic Solutions

    collaborator INDUSTRY

  • PharPoint Research, Inc.

    collaborator INDUSTRY

  • Dinora, Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-12-31
Completion
2017-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02702778 on ClinicalTrials.gov