CLINICAL TRIALS PROFILE FOR DEXONE 0.5

All Clinical Trials for Dexone 0.5

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004228 ↗	Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma	Completed	National Cancer Institute (NCI)	Phase 3	2000-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
NCT00004228 ↗	Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma	Completed	Children's Oncology Group	Phase 3	2000-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
NCT00025259 ↗	Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease	Completed	National Cancer Institute (NCI)	Phase 3	2002-09-01	This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
NCT00025259 ↗	Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease	Completed	Children's Oncology Group	Phase 3	2002-09-01	This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.

Clinical Trial Conditions for Dexone 0.5

Condition Name

Condition Name for Dexone 0.5
Intervention	Trials
Recurrent Plasma Cell Myeloma	34
Refractory Plasma Cell Myeloma	29
Acute Lymphoblastic Leukemia	19
Plasma Cell Myeloma	14

Condition MeSH

Condition MeSH for Dexone 0.5
Intervention	Trials
Multiple Myeloma	61
Neoplasms, Plasma Cell	60
Leukemia	43
Precursor Cell Lymphoblastic Leukemia-Lymphoma	40

Clinical Trial Locations for Dexone 0.5

Trials by Country

Trials by Country for Dexone 0.5
Location	Trials
Canada	140
Australia	64
New Zealand	28
Puerto Rico	15
Switzerland	9

Trials by US State

Trials by US State for Dexone 0.5
Location	Trials
Texas	64
Minnesota	61
California	50
Michigan	44
Florida	44

Clinical Trial Progress for Dexone 0.5

Clinical Trial Phase

Clinical Trial Phase for Dexone 0.5
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	26
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for Dexone 0.5
Clinical Trial Phase	Trials
Recruiting	48
Completed	31
Active, not recruiting	30

Clinical Trial Sponsors for Dexone 0.5

Sponsor Name

Sponsor Name for Dexone 0.5
Sponsor	Trials
National Cancer Institute (NCI)	126
M.D. Anderson Cancer Center	30
Mayo Clinic	24

Sponsor Type

Sponsor Type for Dexone 0.5
Sponsor	Trials
NIH	127
Other	126
Industry	35

Dexona 0.5 MG: Clinical Trials, Market Analysis, and Projections

Introduction

Dexona 0.5 MG, containing the active ingredient dexamethasone, is a steroid medication widely used for its anti-inflammatory, immunosuppressive, and anti-allergic properties. This article will delve into the clinical trials associated with dexamethasone, market analysis, and projections for Dexona 0.5 MG.

Clinical Trials Overview

COVID-19 and ARDS

One of the significant clinical trials involving dexamethasone is the COVID-19 Dexamethasone (CoDEX) trial. This multicenter, randomized, open-label trial was conducted in Brazil to evaluate the efficacy of intravenous dexamethasone in patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to COVID-19. The trial showed that patients receiving dexamethasone had a higher number of ventilator-free days and lower mortality rates compared to those receiving standard care alone[1].

Cancer and Chemotherapy

Dexamethasone is also used in combination with other drugs in cancer treatment. For instance, in the trials for AKYNZEO, dexamethasone was used in conjunction with palonosetron to prevent nausea and vomiting in patients undergoing highly emetogenic chemotherapy. These trials demonstrated the efficacy of this combination in reducing emetic episodes[3].

Multiple Myeloma

In the context of multiple myeloma, dexamethasone was used in combination with XPOVIO (selinexor) in a multicenter, single-arm, open-label trial. This trial showed that 25% of patients treated with this combination experienced an improvement in their disease that lasted about 4 months[4].

Uses and Indications of Dexona 0.5 MG

Inflammatory Conditions and Allergies

Dexona 0.5 MG is primarily used to treat a wide range of inflammatory conditions, allergies, and autoimmune disorders. It reduces the formation of inflammation-causing substances in the body, making it effective for conditions such as rheumatoid arthritis, asthma, and severe allergic reactions[2].

Cancer Treatment

Dexamethasone is also used in the treatment of certain types of cancer, including multiple myeloma, where it is often combined with other chemotherapeutic agents to enhance efficacy[4].

Side Effects and Contraindications

Common Side Effects

The use of Dexona 0.5 MG is associated with several side effects, including stomach discomforts, insomnia, mood swings, dizziness, and restlessness. Prolonged use can lead to more severe side effects such as Cushing's syndrome, visual disturbances, and suppressed adrenal gland activity[2].

Contraindications

While Dexona 0.5 MG is beneficial for many conditions, it is contraindicated in patients with certain infections, such as fungal infections, and in those with a history of peptic ulcers. It also impairs fertility and should be used cautiously in children and adolescents due to its potential to retard growth[2].

Market Analysis

Demand and Supply

The demand for Dexona 0.5 MG is driven by its versatile use in various medical conditions. The COVID-19 pandemic has further increased the demand for dexamethasone due to its role in treating severe COVID-19 cases. The supply chain, however, has been subject to fluctuations due to global health crises and regulatory changes.

Competitive Landscape

The market for dexamethasone is competitive, with several brands available, including Decdan, Dexacron, and Dexacip. The pricing is generally affordable, with the offer price for Dexona 0.5 MG tablets being around ₹6.50 per tablet[2].

Regulatory Environment

Regulatory approvals and guidelines play a crucial role in the market dynamics of Dexona 0.5 MG. For instance, the FDA's accelerated approval program for drugs like XPOVIO, which is used in combination with dexamethasone, has expanded the therapeutic indications for dexamethasone[4].

Projections

Future Demand

Given the broad therapeutic applications of dexamethasone, the demand for Dexona 0.5 MG is expected to remain steady. The ongoing need for effective treatments in autoimmune diseases, allergies, and cancer will continue to drive the market.

Emerging Trends

The use of dexamethasone in combination therapies, as seen in the trials for AKYNZEO and XPOVIO, is an emerging trend. This approach is likely to expand the market for Dexona 0.5 MG as more combination therapies are developed and approved.

Challenges and Opportunities

One of the challenges facing the market is the potential for side effects and contraindications, which may lead to the development of alternative treatments. However, the versatility and efficacy of dexamethasone provide significant opportunities for growth, especially in the context of personalized medicine and precision healthcare.

Key Takeaways

• Clinical Efficacy: Dexamethasone has shown significant efficacy in various clinical trials, including those for COVID-19, cancer, and multiple myeloma.
• Market Demand: The demand for Dexona 0.5 MG is driven by its wide range of therapeutic applications and is expected to remain steady.
• Regulatory Environment: Regulatory approvals and guidelines continue to shape the market dynamics for dexamethasone.
• Side Effects and Contraindications: While effective, the use of Dexona 0.5 MG is associated with several side effects and contraindications that need careful management.

FAQs

Q: What are the primary uses of Dexona 0.5 MG?

A: Dexona 0.5 MG is used to treat inflammatory conditions, allergies, autoimmune disorders, and certain types of cancer.

Q: What were the findings of the CoDEX trial regarding dexamethasone in COVID-19 patients?

A: The CoDEX trial found that dexamethasone increased the number of days alive and free from mechanical ventilation in patients with moderate to severe ARDS due to COVID-19[1].

Q: How is dexamethasone used in cancer treatment?

A: Dexamethasone is often used in combination with other chemotherapeutic agents to prevent nausea and vomiting and to treat certain types of cancer, such as multiple myeloma[3][4].

Q: What are the common side effects of Dexona 0.5 MG?

A: Common side effects include stomach discomforts, insomnia, mood swings, dizziness, and restlessness. Prolonged use can lead to more severe side effects like Cushing's syndrome[2].

Q: Is Dexona 0.5 MG contraindicated in any specific conditions?

A: Yes, it is contraindicated in patients with certain infections, peptic ulcers, and those with a history of fungal infections. It also impairs fertility and should be used cautiously in children and adolescents[2].

Sources

1. Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With COVID-19 and Moderate to Severe Acute Respiratory Distress Syndrome: The CoDEX Randomized Clinical Trial. JAMA. 2020.
2. Dexona 0.5 MG Tablet (30): Uses, Side Effects, Price & Dosage. Pharmeasy.
3. Drug Trials Snapshots: AKYNZEO. FDA.
4. Drug Trials Snapshots: XPOVIO. FDA.

Last updated: 2025-01-04