Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Medtronic
Baxter
Moodys
Dow

Last Updated: December 12, 2019

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR METHYLPREDNISOLONE

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

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.
>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.
>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
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Condition MeSH

Condition MeSH for methylprednisolone
Intervention Trials
Leukemia 78
Lymphoma 62
Syndrome 57
Myelodysplastic Syndromes 40
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Locations for methylprednisolone

Trials by Country

Trials by Country for methylprednisolone
Location Trials
United States 925
Canada 76
China 55
Australia 30
Denmark 26
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Trials by US State

Trials by US State for methylprednisolone
Location Trials
Texas 68
New York 50
California 48
Pennsylvania 43
Ohio 38
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Progress for methylprednisolone

Clinical Trial Phase

Clinical Trial Phase for methylprednisolone
Clinical Trial Phase Trials
Phase 4 103
Phase 3 103
Phase 2/Phase 3 33
[disabled in preview] 162
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Status

Clinical Trial Status for methylprednisolone
Clinical Trial Phase Trials
Completed 199
Recruiting 112
Not yet recruiting 64
[disabled in preview] 52
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Sponsors for methylprednisolone

Sponsor Name

Sponsor Name for methylprednisolone
Sponsor Trials
National Cancer Institute (NCI) 61
M.D. Anderson Cancer Center 24
Rigshospitalet, Denmark 13
[disabled in preview] 11
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Sponsor Type

Sponsor Type for methylprednisolone
Sponsor Trials
Other 625
Industry 113
NIH 102
[disabled in preview] 7
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
McKinsey
AstraZeneca
Baxter
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.