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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research Limited
ClinicalTrials.gov Identifier:
NCT01821040
First received: March 14, 2013
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Polymyalgia Rheumatica
Drug: Lodotra®
Drug: Prednisone IR (immediate release)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Mundipharma Research Limited:

Primary Outcome Measures:
  • To show that treatment with Lodotra® is noninferior to treatment with prednisone IR with regards to the percentage of complete responders. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient reported outcomes [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: March 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lodotra®
Lodotra, starting dose of 15mg administered in the evening
Drug: Lodotra®
Lodotra, starting dose of 15mg administered in the evening
Other Name: Modified release prednisone
Active Comparator: Prednisone IR
Prednisone IR 15mg daily start dose (immediate release) administered in the morning
Drug: Prednisone IR (immediate release)
Prednisone IR 15mg daily start dose (immediate release) administered in the morning,

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01821040

Locations
United Kingdom
Southend University Hospital
Westcliff on Sea, United Kingdom, SS9 9RY
Sponsors and Collaborators
Mundipharma Research Limited
  More Information

No publications provided

Responsible Party: Mundipharma Research Limited
ClinicalTrials.gov Identifier: NCT01821040     History of Changes
Other Study ID Numbers: LOD3501, 2011-002353-57
Study First Received: March 14, 2013
Last Updated: April 1, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Mundipharma Research Limited:
Polymyalgia rheumatica
PMR
Modified release prednisone

Additional relevant MeSH terms:
Polymyalgia Rheumatica
Giant Cell Arteritis
Stress, Psychological
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Arteritis
Vascular Diseases
Cardiovascular Diseases
Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Behavioral Symptoms
Prednisone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 28, 2014