TerminatedPhase 3

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

United Kingdom62 participantsStarted 2013-03

Plain-language summary

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

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Males or females, 50 years of age or older who provided written informed consent.
. Females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner).
. Subjects newly diagnosed with polymyalgia rheumatica and previously untreated with glucocorticoids for PMR. The diagnosis of polymyalgia rheumatica must be confirmed by all of the following criteria:
. Subjects willing and able to participate in all aspects of the study and comply with the use of study medication.

Exclusion criteria

. Females who are pregnant (positive β-hCG test) or lactating.
. Subjects with any contraindication/history of hypersensitivity to predniso(lo)ne or other ingredients.
. Significant renal impairment (serume creatinine \> 150 µmol/L).
. Significant hepatic impairment (ALT, AST and GGT \> 2.5 ULN).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To show that treatment with Lodotra® is noninferior to treatment with prednisone IR with regards to the percentage of complete responders.

Timeframe: 4 weeks

Trial details

NCT IDNCT01821040

SponsorMundipharma Research Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-04

View on ClinicalTrials.gov More Polymyalgia Rheumatica trials