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Last Updated: November 2, 2024

CLINICAL TRIALS PROFILE FOR PREDNISONE


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505(b)(2) Clinical Trials for PREDNISONE

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 Combination NCT00116961 ↗ Velcade, Doxil, and Dexamethasone (VDd) as First Line Therapy for Multiple Myeloma Completed University of Michigan Cancer Center Phase 2 2005-06-01 This is a research study for patients with newly diagnosed multiple myeloma. Multiple myeloma remains a non-curable disease however, newer medications and their combinations appear to provide higher response rates and higher complete response rates than current treatment options. One of the new medications in multiple myeloma is Velcade. Preliminary results from a study using a combination of Velcade with Doxil have shown high response rates (disease reduction). Preliminary results also show that an addition of dexamethasone to Velcade in patients not responding to Velcade alone showed improved response rates. This study involves treatment with a new combination of three standard medications: Velcade, Doxil, and dexamethasone (VDd combination). The proposed combination of all three drugs may improve efficacy and response. Velcade is approved by the Food and Drug Administration (FDA) for treatment in multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Velcade is still currently under investigation for other indications. Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients with some other cancers. Several published clinical trials provide evidence that Doxil is an active agent in multiple myeloma and it is used in treatment combinations for multiple myeloma in general practice. Dexamethasone is a standard therapy for multiple myeloma, but is not approved by the FDA for that use. The combination of all three drugs is experimental (not FDA approved). The goals of this study are to determine if this new combination therapy with Velcade, Doxil and dexamethasone is an effective treatment and also to determine the side effects that occur when this combination treatment is given.
New Combination NCT00116961 ↗ Velcade, Doxil, and Dexamethasone (VDd) as First Line Therapy for Multiple Myeloma Completed University of Michigan Rogel Cancer Center Phase 2 2005-06-01 This is a research study for patients with newly diagnosed multiple myeloma. Multiple myeloma remains a non-curable disease however, newer medications and their combinations appear to provide higher response rates and higher complete response rates than current treatment options. One of the new medications in multiple myeloma is Velcade. Preliminary results from a study using a combination of Velcade with Doxil have shown high response rates (disease reduction). Preliminary results also show that an addition of dexamethasone to Velcade in patients not responding to Velcade alone showed improved response rates. This study involves treatment with a new combination of three standard medications: Velcade, Doxil, and dexamethasone (VDd combination). The proposed combination of all three drugs may improve efficacy and response. Velcade is approved by the Food and Drug Administration (FDA) for treatment in multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Velcade is still currently under investigation for other indications. Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients with some other cancers. Several published clinical trials provide evidence that Doxil is an active agent in multiple myeloma and it is used in treatment combinations for multiple myeloma in general practice. Dexamethasone is a standard therapy for multiple myeloma, but is not approved by the FDA for that use. The combination of all three drugs is experimental (not FDA approved). The goals of this study are to determine if this new combination therapy with Velcade, Doxil and dexamethasone is an effective treatment and also to determine the side effects that occur when this combination treatment is given.
New Dosage NCT01760226 ↗ Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies Completed National Cancer Institute (NCI) Early Phase 1 2013-01-01 The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage NCT01760226 ↗ Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies Completed Texas Children's Hospital Early Phase 1 2013-01-01 The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage NCT01760226 ↗ Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies Completed Baylor College of Medicine Early Phase 1 2013-01-01 The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for PREDNISONE

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.
NCT00000178 ↗ Multicenter Trial of Prednisone in Alzheimer's Disease Completed National Institute on Aging (NIA) Phase 3 1969-12-31 This is a randomized placebo controlled, double blind study. Patients who meet eligibility criteria and decide to participate in the study will be randomly assigned to receive either drug treatment or a placebo. Neither the patients nor the participating investigators will know who is receiving the drugs and who is receiving the placebo. Participation involves 15 outpatient clinic visits over a 68 week period. Patients take study medication at varying doses (the maximum dose is 20 mg daily), along with calcium and vitamin supplements.
NCT00000361 ↗ Autoimmunity in Inner Ear Disease Terminated National Institute on Deafness and Other Communication Disorders (NIDCD) Phase 3 1998-03-01 The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive sensorineural hearing loss in both ears. This condition is called autoimmune inner ear disease (AIED), because it is thought that the hearing loss is triggered by an autoimmune process. Treatment attempts to suppress or control this process with powerful anti-inflammatory drugs. This is a Phase III, outpatient study. All study participants will be assigned to one of four different groups testing the experimental use of drugs. The study is scheduled to run for 18 months, with a minimum of 11 visits per participant.
NCT00000401 ↗ Oral Collagen for Rheumatoid Arthritis Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 2 1999-07-01 Rheumatoid arthritis (RA) is an autoimmune disease characterized by swelling and inflammation of the joints. In RA, the immune system attacks a person's own cells inside joints, eventually leading to joint damage and disability. This study will determine if oral bovine type II collagen (bovine CII) will lead to decreased joint inflammation in RA patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PREDNISONE

Condition Name

Condition Name for PREDNISONE
Intervention Trials
Prostate Cancer 161
Lymphoma 151
Multiple Myeloma 82
Leukemia 66
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Condition MeSH

Condition MeSH for PREDNISONE
Intervention Trials
Lymphoma 471
Prostatic Neoplasms 328
Lymphoma, B-Cell 179
Lymphoma, Large B-Cell, Diffuse 165
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Clinical Trial Locations for PREDNISONE

Trials by Country

Trials by Country for PREDNISONE
Location Trials
Canada 801
Mexico 92
Switzerland 82
Czechia 72
Austria 72
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Trials by US State

Trials by US State for PREDNISONE
Location Trials
California 418
New York 396
Texas 356
Maryland 295
Ohio 283
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Clinical Trial Progress for PREDNISONE

Clinical Trial Phase

Clinical Trial Phase for PREDNISONE
Clinical Trial Phase Trials
Phase 4 264
Phase 3 437
Phase 2/Phase 3 68
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Clinical Trial Status

Clinical Trial Status for PREDNISONE
Clinical Trial Phase Trials
Completed 883
Recruiting 337
Terminated 201
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Clinical Trial Sponsors for PREDNISONE

Sponsor Name

Sponsor Name for PREDNISONE
Sponsor Trials
National Cancer Institute (NCI) 291
M.D. Anderson Cancer Center 58
Hoffmann-La Roche 50
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Sponsor Type

Sponsor Type for PREDNISONE
Sponsor Trials
Other 2172
Industry 1010
NIH 443
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