NCT01821040

A Study Assessing the Efficacy and Safety of Lodotra® Compared to Prednisone IR in Subjects Suffering From PMR

A Randomised, Multi-centre, Double-blind, Active-controlled, Parallel Group Study to Assess the Efficacy and Safety of Modified Release Prednisone (Lodotra®) Compared to Immediate Release Prednisone (Prednisone IR) in Subjects Suffering From Polymyalgia Rheumatica (PMR).

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The study compares the efficacy and safety of modified release prednisone versus immediate release prednisone in patients suffering from polymyalgia rheumatica.

Detailed description

The study consists of a screening phase, followed by a 4 week double-blind phase. During the double-blind phase, the patients will be randomised in a 1:1 ratio to either Lodotra® or immediate release prednisone (prednisone IR) plus respective placebo. After completion of the double-blind phase, patients will be re-randomised in a 1:1 ratio to open-label Lodotra® or prednisone IR for 48 weeks. During the open-label phase, the dose of study medication will be tapered based on titration criteria.

Conditions

• Polymyalgia Rheumatica

Interventions

Type	Name	Description
DRUG	Lodotra®	Lodotra, starting dose of 15mg administered in the evening
DRUG	Prednisone IR (immediate release)	Prednisone IR 15mg daily start dose (immediate release) administered in the morning,

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-03-29
• Last updated: 2018-10-24

Locations

1 site across 1 country: United Kingdom