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

NCT01821040 | Terminated Phase 3

• 2 other identifiers: LOD35012011-002353-57
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polymyalgia Rheumatica

Keywords

Polymyalgia rheumatica; PMR; Modified release prednisone

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (1)

• Patient reported outcomes

  4 weeks

Study Arms (2)

Lodotra®

EXPERIMENTAL

Lodotra, starting dose of 15mg administered in the evening

Drug: Lodotra®

Prednisone IR

ACTIVE COMPARATOR

Prednisone IR 15mg daily start dose (immediate release) administered in the morning

Drug: Prednisone IR (immediate release)

Interventions

Lodotra® DRUG

Lodotra, starting dose of 15mg administered in the evening

Also known as: Modified release prednisone

Lodotra®

Prednisone IR (immediate release) DRUG

Prednisone IR 15mg daily start dose (immediate release) administered in the morning,

Prednisone IR

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mundipharma Research Limited: lead

Study Sites (1)

Southend University Hospital

Westcliff-on-Sea, SS9 9RY, United Kingdom

Location

Related Links

• Link to Results

MeSH Terms

Conditions

Polymyalgia Rheumatica

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 29, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

GB (1)