CLINICAL TRIALS PROFILE FOR DELTA-CORTEF

All Clinical Trials for DELTA-CORTEF

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003593 ↗	Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome	Completed	National Cancer Institute (NCI)	Phase 3	1999-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating children who have Down syndrome and myeloproliferative disorder, acute myelogenous leukemia, or myelodysplastic syndrome.
NCT00002970 ↗	506U78 in Treating Patients With Refractory Hematologic Cancer	Completed	Children's Cancer Group	Phase 2	1997-06-01	Phase II trial to study the effectiveness of 506U78 in treating patients with recurrent or refractory hematologic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
NCT00002970 ↗	506U78 in Treating Patients With Refractory Hematologic Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1997-06-01	Phase II trial to study the effectiveness of 506U78 in treating patients with recurrent or refractory hematologic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
NCT00002798 ↗	Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome	Completed	National Cancer Institute (NCI)	Phase 3	1996-08-01	Randomized phase III trial to compare the effectiveness of different chemotherapy regimens with or without bone marrow transplantation in treating children who have acute myelogenous leukemia or myelodysplastic syndrome. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia or myelodysplastic syndrome
NCT00002855 ↗	Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 3	1996-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
NCT00002855 ↗	Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer	Completed	M.D. Anderson Cancer Center	Phase 3	1996-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.

Clinical Trial Conditions for DELTA-CORTEF

Condition Name

Condition Name for DELTA-CORTEF
Intervention	Trials
Prostate Cancer	4
Adrenal Insufficiency	3
Recurrent Childhood Acute Lymphoblastic Leukemia	3
T-cell Childhood Acute Lymphoblastic Leukemia	3

Condition MeSH

Condition MeSH for DELTA-CORTEF
Intervention	Trials
Leukemia	10
Precursor Cell Lymphoblastic Leukemia-Lymphoma	7
Leukemia, Lymphoid	7
Prostatic Neoplasms	5

Clinical Trial Locations for DELTA-CORTEF

Trials by Country

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Trials by Country for DELTA-CORTEF
Location	Trials
United States	366
Canada	46
Australia	13
New Zealand	6
Puerto Rico	6

Trials by US State

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Trials by US State for DELTA-CORTEF
Location	Trials
California	15
Texas	12
Pennsylvania	11
Massachusetts	10
Ohio	10

Clinical Trial Progress for DELTA-CORTEF

Clinical Trial Phase

Clinical Trial Phase for DELTA-CORTEF
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	9
Phase 2	9

Clinical Trial Status

Clinical Trial Status for DELTA-CORTEF
Clinical Trial Phase	Trials
Completed	15
Recruiting	5
Active, not recruiting	4

Clinical Trial Sponsors for DELTA-CORTEF

Sponsor Name

Sponsor Name for DELTA-CORTEF
Sponsor	Trials
National Cancer Institute (NCI)	15
Children's Oncology Group	6
Diurnal Limited	4

Sponsor Type

Sponsor Type for DELTA-CORTEF
Sponsor	Trials
Other	43
NIH	18
Industry	14

Delta-Cortef: Clinical Trials, Market Analysis, and Projections

Introduction

Delta-Cortef, also known as prednisolone, is a widely used corticosteroid for treating various medical conditions, including inflammation, immune system disorders, and certain types of cancer. This article will provide an update on the clinical trials involving Delta-Cortef, analyze its market position, and offer projections for its future use.

Clinical Trials Overview

Recent Studies

Several clinical trials have been conducted to evaluate the efficacy and safety of corticosteroids like Delta-Cortef in different patient populations.

Dexamethasone and Hydrocortisone Interaction

A recent phase 3, double-blind, randomized controlled trial investigated the use of hydrocortisone to mitigate dexamethasone-induced neurobehavioral problems in pediatric patients with acute lymphoblastic leukemia (ALL). While this study focused on hydrocortisone, it highlights the complex interactions between different corticosteroids and their side effects, which is relevant to Delta-Cortef[1].

Adrenal Suppression

A phase 2b clinical trial compared the effects of vamorolone and prednisone on adrenal suppression in patients with Duchenne muscular dystrophy. This study, although focused on vamorolone, provides insights into the adrenal suppression effects of corticosteroids like prednisone, which is closely related to Delta-Cortef[4].

Ongoing and Planned Trials

Ongoing clinical trials continue to explore the efficacy and safety of Delta-Cortef in various conditions. For instance, numerous phase 2, 3, and 4 trials are listed on clinical trial registries, indicating a robust pipeline of research aimed at optimizing the use of this medication[5].

Mechanism of Action and Uses

Mechanism of Action

Delta-Cortef acts as a glucocorticoid receptor agonist, which means it binds to glucocorticoid receptors in cells, influencing gene expression and reducing inflammation and immune responses. This mechanism is crucial for its therapeutic effects in conditions such as arthritis, blood problems, immune system disorders, skin and eye conditions, and breathing problems[5].

Indicated Conditions

Delta-Cortef is used to treat a wide range of conditions, including:

• Arthritis: To reduce inflammation and pain.
• Blood Problems: Such as anemia and blood clotting disorders.
• Immune System Disorders: Including autoimmune diseases.
• Skin and Eye Conditions: Such as eczema and uveitis.
• Breathing Problems: Including asthma and COPD.
• Cancer: To manage symptoms and side effects of chemotherapy[2].

Market Analysis

Market Position

Delta-Cortef is a well-established medication with a strong market presence. Its versatility in treating various conditions makes it a staple in many healthcare settings. The market for corticosteroids is substantial, driven by the prevalence of inflammatory and immune-mediated diseases.

Competition

The corticosteroid market is competitive, with several other medications available, such as dexamethasone and hydrocortisone. However, Delta-Cortef's broad range of indications and its well-documented safety and efficacy profile maintain its market share.

Economic Impact

The economic impact of Delta-Cortef is significant, given its widespread use. It is often prescribed for long-term management of chronic conditions, which contributes to its steady demand. Additionally, the medication is relatively affordable compared to newer, more specialized treatments, making it accessible to a broader patient population.

Projections and Future Outlook

Growing Demand

The demand for Delta-Cortef is expected to grow due to the increasing prevalence of chronic inflammatory and immune-mediated diseases. Aging populations and rising healthcare standards in developing countries are also likely to drive demand.

Emerging Trends

There is a trend towards more targeted and safer corticosteroid therapies, which could impact the market share of Delta-Cortef. However, its established position and the ongoing research to optimize its use are likely to sustain its relevance.

Regulatory Environment

Regulatory changes and guidelines can influence the market for Delta-Cortef. For example, stricter regulations on the use of corticosteroids to minimize side effects could affect prescribing patterns. However, given its long history of safe use, Delta-Cortef is likely to remain a preferred option for many healthcare providers.

Side Effects and Safety Considerations

Common Side Effects

Delta-Cortef can cause several side effects, including stomach upset, mood changes, and increased appetite. Long-term use can lead to more serious side effects such as adrenal suppression, osteoporosis, and increased risk of infections[2].

Safety Measures

To mitigate these risks, healthcare providers closely monitor patients on long-term corticosteroid therapy. Gradual tapering of the dose is recommended when stopping the medication to avoid withdrawal symptoms and adrenal insufficiency[2].

Key Takeaways

• Clinical Trials: Ongoing and recent trials continue to evaluate the efficacy and safety of Delta-Cortef, particularly in mitigating side effects and optimizing dosing regimens.
• Market Position: Delta-Cortef remains a widely used and essential medication due to its broad range of indications and established safety profile.
• Projections: The demand for Delta-Cortef is expected to grow driven by increasing prevalence of chronic diseases and aging populations.
• Safety Considerations: Healthcare providers must be aware of potential side effects and take necessary precautions to ensure safe use.

FAQs

Q: What is Delta-Cortef used for?

A: Delta-Cortef, or prednisolone, is used to treat conditions such as arthritis, blood problems, immune system disorders, skin and eye conditions, breathing problems, and certain types of cancer.

Q: How does Delta-Cortef work?

A: Delta-Cortef acts as a glucocorticoid receptor agonist, reducing inflammation and immune responses by influencing gene expression.

Q: What are the common side effects of Delta-Cortef?

A: Common side effects include stomach upset, mood changes, and increased appetite. Long-term use can lead to more serious side effects like adrenal suppression and osteoporosis.

Q: Can Delta-Cortef be stopped abruptly?

A: No, Delta-Cortef should not be stopped abruptly. The dose should be gradually tapered to avoid withdrawal symptoms and adrenal insufficiency.

Q: Is Delta-Cortef safe for long-term use?

A: While Delta-Cortef is generally safe, long-term use requires careful monitoring to mitigate risks such as adrenal suppression and osteoporosis.

Sources

1. Hydrocortisone to reduce dexamethasone-induced neurobehavioral problems in pediatric patients with ALL. European Journal of Cancer, 2023.
2. Delta-Cortef Tablet - Uses, Side Effects, and More. WebMD.
3. CLINICAL TRIAL PROTOCOL A Phase II, Randomized, Double-Blind, Placebo-Controlled Study. ClinicalTrials.gov.
4. Adrenal Suppression From Vamorolone and Prednisone in Duchenne Muscular Dystrophy. Journal of Clinical Endocrinology and Metabolism, 2024.
5. Prednisone: Uses, Interactions, Mechanism of Action. DrugBank.