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Last Updated: April 16, 2021

DrugPatentWatch Database Preview

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.
New Formulation NCT01405131 A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Withdrawn Pfizer Phase 1 2012-01-01 A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets.
New Formulation NCT01405157 A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Under Fasting Conditions Withdrawn Pfizer Phase 1 2012-01-01 A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fasting conditions.
>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.
NCT00000596 Diffuse Fibrotic Lung Disease Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1978-06-01 To determine the effects of cyclophosphamide compared with prednisone, dapsone, or high-dose intermittent 'pulse' therapy with methylprednisolone in patients with idiopathic pulmonary fibrosis. Also, to evaluate the use of intermittent, short-term, high-dose intravenous corticosteroids in patients with sarcoidosis. There were actually four separate clinical trials.
NCT00000730 Comparison of Three Treatments for Pneumocystis Pneumonia in AIDS Patients Terminated National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1969-12-31 This study compares three different therapies for treatment of refractory Pneumocystis carinii pneumonia (PCP) in patients with AIDS. "Refractory" means that the patient has failed to respond to at least 4 days of treatment with either of two standard therapies: (1) sulfamethoxazole/trimethoprim (SMX/TMP) or (2) pentamidine (PEN). This study compares therapy with trimetrexate (TMTX) and leucovorin (LCV) to standard therapy and standard therapy plus high-dose steroids (methylprednisolone). The purpose is to find better and safer forms of treatment for PCP in AIDS patients. There is at present no scientific information about the best treatment for an AIDS patient with PCP who is not improving while receiving the standard therapies (SMX/TMP or PEN). New drug treatments are available, including steroid therapy and TMTX, but there is no information proving that these new treatments work better than the standard therapies.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Methylprednisolone

Condition Name

Condition Name for Methylprednisolone
Intervention Trials
Leukemia 57
Lymphoma 46
Myelodysplastic Syndromes 32
Graft Versus Host Disease 25
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Condition MeSH

Condition MeSH for Methylprednisolone
Intervention Trials
Leukemia 78
Lymphoma 63
Syndrome 63
Graft vs Host Disease 43
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Clinical Trial Locations for Methylprednisolone

Trials by Country

Trials by Country for Methylprednisolone
Location Trials
Canada 78
China 62
Italy 42
Spain 33
Australia 33
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Trials by US State

Trials by US State for Methylprednisolone
Location Trials
Texas 72
California 56
New York 55
Pennsylvania 47
Ohio 41
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Clinical Trial Progress for Methylprednisolone

Clinical Trial Phase

Clinical Trial Phase for Methylprednisolone
Clinical Trial Phase Trials
Phase 4 115
Phase 3 124
Phase 2/Phase 3 38
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Clinical Trial Status

Clinical Trial Status for Methylprednisolone
Clinical Trial Phase Trials
Completed 209
Recruiting 133
Not yet recruiting 107
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Clinical Trial Sponsors for Methylprednisolone

Sponsor Name

Sponsor Name for Methylprednisolone
Sponsor Trials
National Cancer Institute (NCI) 63
M.D. Anderson Cancer Center 25
Rigshospitalet, Denmark 14
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Sponsor Type

Sponsor Type for Methylprednisolone
Sponsor Trials
Other 727
Industry 128
NIH 105
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