A Study Assessing the Efficacy and Safety of Lodotra® Compared to Prednisone IR in Subjects Suffering From PMR
Primary Purpose
Polymyalgia Rheumatica
Status
Terminated
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Lodotra®
Prednisone IR (immediate release)
Sponsored by
About this trial
This is an interventional treatment trial for Polymyalgia Rheumatica focused on measuring Polymyalgia rheumatica, PMR, Modified release prednisone
Eligibility Criteria
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:
- 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).
- 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).
- 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.
- Continued use of systemic glucocorticoids within 4 weeks prior to the Screening Visit.
- Joint injections with glucocorticoids within 6 weeks prior to the Screening Visit.
- Subjects who require treatment with non-permitted concomitant therapies.
- 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.
- Active alcohol or drug abuse.
- Subjects suffering from giant cell arteritis, late onset rheumatoid arthritis or other inflammatory rheumatoid diseases.
- Subjects suffering from drug-induced myalgia.
- Subjects suffering from fibromyalgia
- Subjects suffering from systemic lupus erythemathosus.
- Subjects suffering from neurological conditions, e.g. Parkinson's disease.
- Subjects suffering from active cancer.
- Subjects suffering from an active infection.
- 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.
Sites / Locations
- Southend University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lodotra®
Prednisone IR
Arm Description
Lodotra, starting dose of 15mg administered in the evening
Prednisone IR 15mg daily start dose (immediate release) administered in the morning
Outcomes
Primary Outcome Measures
To show that treatment with Lodotra® is noninferior to treatment with prednisone IR with regards to the percentage of complete responders.
Secondary Outcome Measures
Patient reported outcomes
Full Information
NCT ID
NCT01821040
First Posted
March 14, 2013
Last Updated
October 22, 2018
Sponsor
Mundipharma Research Limited
1. Study Identification
Unique Protocol Identification Number
NCT01821040
Brief Title
A Study Assessing the Efficacy and Safety of Lodotra® Compared to Prednisone IR in Subjects Suffering From PMR
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 Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Research Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polymyalgia Rheumatica
Keywords
Polymyalgia rheumatica, PMR, Modified release prednisone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lodotra®
Arm Type
Experimental
Arm Description
Lodotra, starting dose of 15mg administered in the evening
Arm Title
Prednisone IR
Arm Type
Active Comparator
Arm Description
Prednisone IR 15mg daily start dose (immediate release) administered in the morning
Intervention Type
Drug
Intervention Name(s)
Lodotra®
Other Intervention Name(s)
Modified release prednisone
Intervention Description
Lodotra, starting dose of 15mg administered in the evening
Intervention Type
Drug
Intervention Name(s)
Prednisone IR (immediate release)
Intervention Description
Prednisone IR 15mg daily start dose (immediate release) administered in the morning,
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Patient reported outcomes
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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).
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).
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.
Continued use of systemic glucocorticoids within 4 weeks prior to the Screening Visit.
Joint injections with glucocorticoids within 6 weeks prior to the Screening Visit.
Subjects who require treatment with non-permitted concomitant therapies.
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.
Active alcohol or drug abuse.
Subjects suffering from giant cell arteritis, late onset rheumatoid arthritis or other inflammatory rheumatoid diseases.
Subjects suffering from drug-induced myalgia.
Subjects suffering from fibromyalgia
Subjects suffering from systemic lupus erythemathosus.
Subjects suffering from neurological conditions, e.g. Parkinson's disease.
Subjects suffering from active cancer.
Subjects suffering from an active infection.
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.
Facility Information:
Facility Name
Southend University Hospital
City
Westcliff on Sea
ZIP/Postal Code
SS9 9RY
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=LOD3501
Description
Link to Results
Learn more about this trial
A Study Assessing the Efficacy and Safety of Lodotra® Compared to Prednisone IR in Subjects Suffering From PMR
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