A Study Assessing the Efficacy and Safety of Lodotra® Compared to Prednisone IR in Subjects Suffering From PMR
Information source: Mundipharma Research Limited
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polymyalgia Rheumatica
Intervention: Lodotra® (Drug); Prednisone IR (immediate release) (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Mundipharma Research Limited
Summary
The study compares the efficacy and safety of modified release prednisone versus immediate
release prednisone in patients suffering from polymyalgia rheumatica.
Clinical Details
Official 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).
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: To show that treatment with Lodotra® is noninferior to treatment with prednisone IR with regards to the percentage of complete responders.
Secondary outcome: Patient reported outcomes
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.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Males or females, 50 years of age or older who provided written informed consent.
2. 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).
3. 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:
- New onset bilateral shoulder pain or new onset bilateral shoulder and hip girdle
pain.
- PMR VAS score over the last 24 hours before the Screening Visit ≥ 50 (on a 0 -
100 scale).
- Morning stiffness duration of ≥ 45 min on the day before the Screening Visit.
- Acute phase response shown by elevated C-reactive protein (CRP; ≥ 2 times ULN).
4. Subjects willing and able to participate in all aspects of the study and comply with
the use of study medication.
Exclusion Criteria:
1. Females who are pregnant (positive β-hCG test) or lactating.
2. Subjects with any contraindication/history of hypersensitivity to predniso(lo)ne or
other ingredients.
3. Significant renal impairment (serume creatinine > 150 µmol/L).
4. Significant hepatic impairment (ALT, AST and GGT > 2. 5 ULN).
5. Subjects suffering from another disease which requires glucocorticosteroid treatment.
Topical glucocorticosteroids, e. g. intra-nasal or inhaled glucocorticosteroids are
allowed but should be kept at a stable dose throughout the study.
6. Continued use of systemic glucocorticoids within 4 weeks prior to the Screening
Visit.
7. Joint injections with glucocorticoids within 6 weeks prior to the Screening Visit.
8. Subjects who require treatment with non-permitted concomitant therapies.
9. Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal
or psychiatric disease at the time of screening, as determined by medical history,
clinical laboratory tests, ECG results, and physical examination, that would place
the subject at risk upon exposure to the study medication or that may confound the
analysis and/or interpretation of the study results.
10. Active alcohol or drug abuse.
11. Subjects suffering from giant cell arteritis, late onset rheumatoid arthritis or
other inflammatory rheumatoid diseases.
12. Subjects suffering from drug-induced myalgia.
13. Subjects suffering from fibromyalgia
14. Subjects suffering from systemic lupus erythemathosus.
15. Subjects suffering from neurological conditions, e. g. Parkinson's disease.
16. Subjects suffering from active cancer.
17. Subjects suffering from an active infection.
18. Subjects who participated in a clinical research study involving a new chemical
entity or an experimental drug within 30 days prior to the Screening Visit.
Locations and Contacts
Southend University Hospital, Westcliff on Sea SS9 9RY, United Kingdom
Additional Information
CSR published on Mundipharma web page
Starting date: March 2013
Last updated: April 9, 2015
|