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Serving leading biopharmaceutical companies globally:

US Army
Fish and Richardson
Healthtrust
Chubb
McKinsey
Medtronic
Cantor Fitzgerald
Baxter
Chinese Patent Office
Farmers Insurance

Generated: November 21, 2017

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR
NEO-MEDROL

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Clinical Trial Listing

Trial ID Title Status Sponsor Phase Summary
NCT00023231 Pediatric Kidney Transplant Without Calcineurin InhibitorsCompletedNational Institute of Allergy and Infectious Diseases (NIAID)N/A The purpose of this study is to see the effect of using drugs other than calcineurin inhibitors to improve the rate of kidney transplant failure. Kidney transplantation can help children with end-stage kidney disease. However, it has been difficult to find treatment for donor graft rejection that does not have a lot of side effects. Researchers hope to find treatments (immunosuppressants) with fewer side effects. One approach is to avoid using calcineurin inhibitors and to try a new drug known as sirolimus instead. Another is to use steroids less often. This study will test whether using sirolimus, fewer steroid treatments, MMF, and certain antibodies will improve long-term graft survival in children receiving kidney transplants from living donors.
NCT00104299 Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic PolyangiitisCompletedGenentech, Inc.Phase 2/Phase 3 Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types of cancer. The purpose of this study is to determine the effectiveness of rituximab in treating patients with WG and MPA. Study hypothesis: Rituximab is not inferior to conventional therapy in its ability to induce disease remission by Month 6.
NCT00104299 Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic PolyangiitisCompletedImmune Tolerance Network (ITN)Phase 2/Phase 3 Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types of cancer. The purpose of this study is to determine the effectiveness of rituximab in treating patients with WG and MPA. Study hypothesis: Rituximab is not inferior to conventional therapy in its ability to induce disease remission by Month 6.
NCT00104299 Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic PolyangiitisCompletedNational Institute of Allergy and Infectious Diseases (NIAID)Phase 2/Phase 3 Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types of cancer. The purpose of this study is to determine the effectiveness of rituximab in treating patients with WG and MPA. Study hypothesis: Rituximab is not inferior to conventional therapy in its ability to induce disease remission by Month 6.
NCT00241982 Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid ArthritisCompletedUtrecht UniversityPhase 2 Trial to study the safety of a single, intravenous administration of long-circulating liposomal prednisolone disodium phosphate in patients with active rheumatoid arthritis.
NCT00241982 Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid ArthritisCompletedRadboud UniversityPhase 2 Trial to study the safety of a single, intravenous administration of long-circulating liposomal prednisolone disodium phosphate in patients with active rheumatoid arthritis.
NCT00279903 Is Botox Effective in Relieving Pain From Knee Osteoarthritis?CompletedMayo ClinicPhase 1 Patients with painful knee osteoarthritis will be randomly allocated to one of three groups. Each group will receive a knee injection of: 1) cortisone, 2) low dose Botox, or 3) high dose Botox. Patients will then be followed for 6 months to see if they have significant pain relief or improvement in their activity level after the injection.
NCT00307606 Does a Single Steroid Injection Reduce the Formation of Postmastectomy SeromaUnknown statusHerlev HospitalPhase 4 Background Seroma formation is a common problem after mastectomy. The incidence various between 30% to 92%. It is often an ongoing problem after removal of the suction drain, and repeated skin puncture is necessary to remove the seroma. In addition to many ambulatory visits this also leads to an increased risk of infection, and the adjuvant treatment can be delayed for several weeks Different procedures have been tried to avoid seroma formation. Among these are for ex. : immobilisation of the arm and shoulder after mastectomy, different drain regimens, closing of the dead space of the cavity, different chemical substances as thrombin, tranexamacid and fibrin. Non of these results has been successful. Seroma formation is most likely the result of the inflammatory response due to wound healing. In the seroma fluid several factors have been detected that support this assumption. These factors are: high levels of IgG, leucocytes, granulocytes, proteinases, proteinases inhibitors, different kinds of cytokines ( tPA, uPA,, uPAR, PAI-1, PAI-2, IL-6 og IL-1). On the basis of this, an inhibition of the inflammatory response might result in a decrease of seroma formation, and perhaps improve quality of life after mastectomy. Steroids inhibit the inflammatory response for example by inhibition of the cytokine function. It has been shown that a high single dose of steroid infusion (30mg/kg solu-medrol) inhibits the normal IL 6 response after colon resection. Newer studies have shown that even at a lower dose the inflammatory response is inhibited. In several studies of head and neck surgery the oedema in surgical area is reduced after a single dose of 125 mg solumedrol. It is precisely this effect of reduced fluid formation we want to obtain in our study. We have therefore chosen to use a single dose of 125 mg of solumedrol in this study. Even at the largest single dose of glucocorticoids there have not been seen any increasing in surgical complications. The aim of the study: To find out whether single dose of glucocorticoid can reduce the seroma formation after mastectomy Study design : A randomised pilot study, with 2 x 20 patients. 125 mg solumedrol is given 1,5 hours before surgery in 20 patients, and the other 20 patients are the control group Inclusion criteria: Women with primary breast cancer, undergoing a mastectomy with either sentinel node biopsy or complete axillary dissection.
NCT00376077 A Randomized Study of IVIG vs. IVIG With High Dose Methylprednisolone in Childhood ITP.CompletedBayerPhase 3 Childhood immune thrombocytopenia purpura (ITP) is a disorder characterized by the production of antibodies against platelets, resulting in enhanced destruction of platelets. Most children with ITP present with low platelet counts (PC) but minimal bleeding. Very rarely a child may present with a severe life-threatening bleed, such as a bleed in the head. In this case it is very important that the PC be raised as quickly as possible. The combination of corticosteroids and intravenous gammaglobulin (IVIG) is commonly used in the management of such severe bleeding in children with ITP to quickly raise the PC and yet this treatment combination has not been tested against using IVIG alone. If it is shown that the combination of these agents does result in a quicker rise in PC then when using IVIG alone would support the use of this combination therapy in emergency situations. As we can not ethically conduct this study in patients with life-threatening bleeds, we plan to study patients with ITP and PC less than 20 X 109/L, but without life threatening bleeding. Eligible patients will be randomized to one of these 2 regimens (IVIG + placebo or IVIG + IV corticosteroids). The study is designed as a double-blind trial, where the patient or the treating physician will not be aware of the regimen that a patient is randomized to. PC's will be measured as a surrogate measure of bleeding risk; bleeding scores (a score generated by observing patients for bleeding symptoms) will be used to grade bleeding severity, and adverse effects to treatment will be monitored by the means of questionnaires throughout the study.
NCT00376077 A Randomized Study of IVIG vs. IVIG With High Dose Methylprednisolone in Childhood ITP.CompletedThe Hospital for Sick ChildrenPhase 3 Childhood immune thrombocytopenia purpura (ITP) is a disorder characterized by the production of antibodies against platelets, resulting in enhanced destruction of platelets. Most children with ITP present with low platelet counts (PC) but minimal bleeding. Very rarely a child may present with a severe life-threatening bleed, such as a bleed in the head. In this case it is very important that the PC be raised as quickly as possible. The combination of corticosteroids and intravenous gammaglobulin (IVIG) is commonly used in the management of such severe bleeding in children with ITP to quickly raise the PC and yet this treatment combination has not been tested against using IVIG alone. If it is shown that the combination of these agents does result in a quicker rise in PC then when using IVIG alone would support the use of this combination therapy in emergency situations. As we can not ethically conduct this study in patients with life-threatening bleeds, we plan to study patients with ITP and PC less than 20 X 109/L, but without life threatening bleeding. Eligible patients will be randomized to one of these 2 regimens (IVIG + placebo or IVIG + IV corticosteroids). The study is designed as a double-blind trial, where the patient or the treating physician will not be aware of the regimen that a patient is randomized to. PC's will be measured as a surrogate measure of bleeding risk; bleeding scores (a score generated by observing patients for bleeding symptoms) will be used to grade bleeding severity, and adverse effects to treatment will be monitored by the means of questionnaires throughout the study.
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Conditions

Condition Name

Condition Name for NEO-MEDROL
Intervention Trials
Osteoarthrosis 6
Leukemia 5
Graft Versus Host Disease 1
Vasculitis 1
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Condition MeSH

Condition MeSH for NEO-MEDROL
Intervention Trials
Osteoarthritis 9
Joint Diseases 6
Leukemia 5
Precursor Cell Lymphoblastic Leukemia-Lymphoma 5
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Trial Locations

Trials by Country

Trials by Country for NEO-MEDROL
Location Trials
United States 31
Denmark 9
India 3
Netherlands 2
Belgium 2
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Trials by US State

Trials by US State for NEO-MEDROL
Location Trials
Texas 5
New York 3
Maryland 3
Illinois 2
Pennsylvania 2
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Clinical Trial Progress

Clinical Trial Phase

Clinical Trial Phase for NEO-MEDROL
Clinical Trial Phase Trials
Phase 4 4
Phase 3 8
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for NEO-MEDROL
Clinical Trial Phase Trials
Completed 14
Recruiting 10
Unknown status 6
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Clinical Trial Sponsors

Sponsor Name

Sponsor Name for NEO-MEDROL
Sponsor Trials
Bispebjerg Hospital 7
Rigshospitalet, Denmark 6
M.D. Anderson Cancer Center 5
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Sponsor Type

Sponsor Type for NEO-MEDROL
Sponsor Trials
Other 45
Industry 14
NIH 4
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Serving leading biopharmaceutical companies globally:

Healthtrust
Colorcon
Cantor Fitzgerald
Teva
Novartis
Argus Health
Chinese Patent Office
US Department of Justice
QuintilesIMS
Fish and Richardson

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