A study assessing Lodotra compared to prednisone IR in PMR patients

• Research type

  Research Study

• Full title

  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)

• IRAS ID

  119268

• Contact name

  Bhaskar Dasgupta

• Sponsor organisation

  Mundipharma Research Limited

• Eudract number

  2011-002353-57

• Research summary

  Polymyalgia rheumatica (PMR) is the most common inflammatory rheumatic disease of the elderly. It is characterised by persisting pain and morning stiffness of the neck, shoulder and hips of at least 4 weeks duration. The stiffness is marked in the morning, causing patients difficulty with getting out of bed and with performing activities of daily living, such as washing and dressing. Pain often interferes with sleep at night and results in significant daytime tiredness. Lodotra© is a modified release tablet originally developed for the low dose prednisone therapy of Rheumatoid Arthritis (RA). The tablet consists of a conventional prednisone core and a press-coated inactive shell which delays the release of prednisone for a defined period of time. Prednisone immediate release products (IR prednisone) are well established drugs for the treatment of several diseases and have been successfully used for decades. However, the benefit of long-term glucocorticoid treatment may often not be optimised in diseases that are characterised by a pronounced cycle variation of symptom severity. The modified release system of Lodotra© was developed to improve oral prednisone treatment by adapting glucocorticoid release and endogenous cortisol and symptom severity. Both of which have their peaks during the early morning hours. This is achieved by the administration of the tablet in the evening, resulting in the release of prednisone in the early morning hours. In patients with active RA already receiving treatment with conventional prednisone, switching to the same dose of Lodotra© for 12 weeks resulted in a significant relative reduction in morning stiffness in RA compared with continuation of prednisone in the morning. PMR and RA have many characteristics in common. In all, prednisone is considered as standard treatment for PMR and patients could potentially benefit from timing prednisone treatment with Lodotra© to mimic the pattern of endogenous cortisol release.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0854

• Date of REC Opinion

  16 Jan 2013

• REC opinion

  Further Information Favourable Opinion