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Last Updated: May 28, 2022

CLINICAL TRIALS PROFILE FOR METHYLPREDNISOLONE


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505(b)(2) Clinical Trials for Methylprednisolone

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00977444 ↗ Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment Unknown status National Council of Science and Technology, Mexico Phase 2/Phase 3 2007-11-01 Abstract Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of knee. A 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried out. 117 patients with OA of the knee will be randomized to receive 1 intra-articular monthly injection of 5 mL of one of the following: 75 mg/mL of Kondrium, 82.5 mg/mL of Kondriumf or 8 mg/mL of methylprednisolone once a month during 3 months. The primary efficacy variable will be the change from baseline to final assessment in the Western Ontario and McMaster University OA index (WOMAC subscale score for pain), and Lequesne´s functional index.
New Formulation NCT00977444 ↗ Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment Unknown status Nucitec Phase 2/Phase 3 2007-11-01 Abstract Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of knee. A 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried out. 117 patients with OA of the knee will be randomized to receive 1 intra-articular monthly injection of 5 mL of one of the following: 75 mg/mL of Kondrium, 82.5 mg/mL of Kondriumf or 8 mg/mL of methylprednisolone once a month during 3 months. The primary efficacy variable will be the change from baseline to final assessment in the Western Ontario and McMaster University OA index (WOMAC subscale score for pain), and Lequesne´s functional index.
New Formulation NCT01267201 ↗ A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form Completed Pfizer Phase 1 2010-11-01 A new formulation of methylprednisolone is being developed. A study is needed to determine the drug availability using the new formulation, a powder for reconstitution into a suspension, versus the current commercially available tablet formulation in healthy volunteers.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Methylprednisolone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000146 ↗ Optic Neuritis Treatment Trial (ONTT) Unknown status National Eye Institute (NEI) Phase 3 1988-07-01 To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis. To determine the natural history of vision in patients who suffer optic neuritis. To identify risk factors for the development of multiple sclerosis in patients with optic neuritis.
NCT00000147 ↗ Longitudinal Optic Neuritis Study (LONS) Unknown status National Eye Institute (NEI) N/A 1988-07-01 To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis. To determine the natural history of vision in patients who suffer optic neuritis. To identify risk factors for the development of multiple sclerosis in patients with optic neuritis.
NCT00000579 ↗ Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1994-09-01 The purposes of this study are to assess rapidly innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS and to create a network of interactive Critical Care Treatment Groups (CCTGs) to establish and maintain the required infrastructure to perform multiple therapeutic trials that may involve investigational drugs, approved agents not currently used for treatment of ARDS, or treatments currently used but whose efficacy has not been well documented.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Methylprednisolone

Condition Name

Condition Name for Methylprednisolone
Intervention Trials
Leukemia 59
Lymphoma 46
Myelodysplastic Syndromes 33
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Condition MeSH

Condition MeSH for Methylprednisolone
Intervention Trials
Leukemia 85
Syndrome 74
Lymphoma 71
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Clinical Trial Locations for Methylprednisolone

Trials by Country

Trials by Country for Methylprednisolone
Location Trials
Canada 150
China 100
Spain 83
Italy 74
France 52
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Trials by US State

Trials by US State for Methylprednisolone
Location Trials
Texas 101
California 94
New York 88
Pennsylvania 70
Ohio 69
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Clinical Trial Progress for Methylprednisolone

Clinical Trial Phase

Clinical Trial Phase for Methylprednisolone
Clinical Trial Phase Trials
Phase 4 156
Phase 3 158
Phase 2/Phase 3 44
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Clinical Trial Status

Clinical Trial Status for Methylprednisolone
Clinical Trial Phase Trials
Completed 368
Recruiting 118
Terminated 92
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Clinical Trial Sponsors for Methylprednisolone

Sponsor Name

Sponsor Name for Methylprednisolone
Sponsor Trials
National Cancer Institute (NCI) 68
M.D. Anderson Cancer Center 27
Hoffmann-La Roche 25
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Sponsor Type

Sponsor Type for Methylprednisolone
Sponsor Trials
Other 968
Industry 208
NIH 128
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