CLINICAL TRIALS PROFILE FOR SODIUM BICARBONATE

505(b)(2) Clinical Trials for Sodium Bicarbonate

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
OTC	NCT01077076 ↗	Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)	Completed	Bayer	Phase 3	2008-12-01	This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to: 1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments; 2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing. 3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.
OTC	NCT04651088 ↗	Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet	Not yet recruiting	University of Texas Southwestern Medical Center	Early Phase 1	2021-12-01	The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.

All Clinical Trials for Sodium Bicarbonate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00045799 ↗	Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill	Completed	Bausch Health Americas, Inc.	Phase 3	2002-05-01	Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00045799 ↗	Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill	Completed	Valeant Pharmaceuticals International, Inc.	Phase 3	2002-05-01	Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00130598 ↗	PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION	Completed	Swiss National Science Foundation	Phase 2/Phase 3	2005-06-01	Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure. Only hydration with saline is uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN. But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with a prolonged infusion of sodium chloride in the prevention of CN. Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.
NCT00130598 ↗	PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION	Completed	University Hospital, Basel, Switzerland	Phase 2/Phase 3	2005-06-01	Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure. Only hydration with saline is uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN. But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with a prolonged infusion of sodium chloride in the prevention of CN. Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.

Clinical Trial Conditions for Sodium Bicarbonate

Condition Name

Condition Name for Sodium Bicarbonate
Intervention	Trials
Metabolic Acidosis	16
Acute Kidney Injury	16
Contrast Induced Nephropathy	15
Chronic Kidney Disease	14

Condition MeSH

Condition MeSH for Sodium Bicarbonate
Intervention	Trials
Kidney Diseases	48
Acute Kidney Injury	30
Renal Insufficiency, Chronic	23
Renal Insufficiency	20

Clinical Trial Locations for Sodium Bicarbonate

Trials by Country

Trials by Country for Sodium Bicarbonate
Location	Trials
United States	196
Italy	19
Brazil	14
Canada	13
Australia	13

Trials by US State

Trials by US State for Sodium Bicarbonate
Location	Trials
California	13
Texas	13
North Carolina	11
New York	11
Florida	11

Clinical Trial Progress for Sodium Bicarbonate

Clinical Trial Phase

Clinical Trial Phase for Sodium Bicarbonate
Clinical Trial Phase	Trials
Phase 4	72
Phase 3	40
Phase 2/Phase 3	14

Clinical Trial Status

Clinical Trial Status for Sodium Bicarbonate
Clinical Trial Phase	Trials
Completed	138
Recruiting	31
Unknown status	30

Clinical Trial Sponsors for Sodium Bicarbonate

Sponsor Name

Sponsor Name for Sodium Bicarbonate
Sponsor	Trials
University of Colorado, Denver	5
Bausch Health Americas, Inc.	5
Valeant Pharmaceuticals International, Inc.	5

Sponsor Type

Sponsor Type for Sodium Bicarbonate
Sponsor	Trials
Other	316
Industry	66
NIH	12

Sodium Bicarbonate: Clinical Trials, Market Analysis, and Projections

Introduction to Sodium Bicarbonate

Sodium bicarbonate, commonly known as baking soda, is a versatile compound with a wide range of applications, from culinary and household uses to medical and industrial purposes. This article will delve into the current clinical trials, market analysis, and future projections for sodium bicarbonate, particularly focusing on its medical applications.

Clinical Trials: Investigating the Efficacy of Sodium Bicarbonate

SODa-BIC Trial

The SODa-BIC (SODium BICarbonate for Metabolic Acidosis in the Intensive Care Unit) trial is a significant multicentre, randomised controlled trial aimed at evaluating the efficacy of sodium bicarbonate in treating metabolic acidosis in critically ill patients. This study compares the use of sodium bicarbonate diluted in 5% dextrose with 5% dextrose alone in patients receiving vasopressor infusions. The primary objective is to determine if sodium bicarbonate reduces Major Adverse Kidney Events within 30 days of randomization[1].

BASE Trial

The BASE Trial, conducted in the UK, investigates the impact of managing metabolic acidosis with sodium bicarbonate in very preterm babies. This multicentre, pragmatic, open-label trial randomizes babies into two groups: one receiving routine sodium bicarbonate infusions for metabolic acidosis and the other not receiving such infusions. The trial aims to assess both short-term and long-term effects on the health and development of these babies[4].

Market Analysis: Current Trends and Projections

Global Market Size and Growth

The global sodium bicarbonate market is experiencing steady growth, driven by increasing demand from various industries such as healthcare, pharmaceuticals, and food and beverages. As of 2023, the market was valued at approximately $4.6 billion and is projected to reach $7.7 billion by 2033, growing at a CAGR of 5.2% during this period[2].

Key Market Segments

Processed Food Segment

The processed food segment is a major driver of the sodium bicarbonate market, accounting for almost 45% of the overall market share. The demand for convenience foods and the need to maintain stable pH levels in baked products contribute significantly to this segment's growth[2].

Pharmaceutical Industry

The pharmaceutical industry is another significant end-user, accounting for close to 18% of overall sales. Sodium bicarbonate is used extensively as an antacid and in hemodialysis solutions for treating chronic kidney diseases. The growing geriatric population and the expansion of the pharmaceutical industry, particularly in India and China, are expected to boost demand further[2][3].

Regional Market Insights

• India and South Asia & Pacific Region: India is a leading market in the South Asia & Pacific region, expected to witness a CAGR of 4.8% during the forecast period. The rapid expansion of the Indian pharmaceutical industry and the high reliance on poultry farming are key factors driving growth[2].
• United States and Canada: These countries are expected to see significant growth, with the U.S. market projected to rise at a CAGR of 2% and Canada at 4.9% during the forecast period[2].

Pharmaceutical-Grade Sodium Bicarbonate Market

The pharmaceutical-grade sodium bicarbonate market is a niche but growing segment. This market is expected to reach $387.7 million by 2034, growing at a CAGR of 3.5% during the forecast period. The increasing consumption of sodium bicarbonate as an active pharmaceutical ingredient (API) in treatments for metabolic acidosis, hemodialysis, and other medical conditions is driving this growth[3].

Emerging Applications

Research and development activities are uncovering new applications for pharmaceutical-grade sodium bicarbonate. For instance, a study by the University of Liverpool and the Karolinska Institute found that administering pharma-grade sodium bicarbonate to women in addition to oxytocin increased their chances of natural vaginal delivery by 17%. Such findings are expected to drive further growth and unlock new uses for sodium bicarbonate[3].

Key Takeaways

• Clinical Trials: Ongoing trials like SODa-BIC and BASE are crucial for understanding the efficacy and safety of sodium bicarbonate in treating metabolic acidosis in different patient populations.
• Market Growth: The global sodium bicarbonate market is projected to grow significantly, driven by demand from the healthcare, pharmaceutical, and food industries.
• Regional Insights: India, China, and the U.S. are key regions expected to drive market growth due to their expanding pharmaceutical and food processing sectors.
• Pharmaceutical-Grade Market: This segment is growing steadily, driven by its use as an API in various medical treatments.

FAQs

What is the primary objective of the SODa-BIC trial?

The primary objective of the SODa-BIC trial is to determine if sodium bicarbonate reduces Major Adverse Kidney Events within 30 days of randomization in critically ill patients with metabolic acidosis.

How is the BASE Trial different from the SODa-BIC trial?

The BASE Trial focuses on the management of metabolic acidosis in very preterm babies, comparing routine use of sodium bicarbonate infusions with no routine use, while the SODa-BIC trial investigates the use of sodium bicarbonate in critically ill adults.

What are the key drivers of the sodium bicarbonate market?

The key drivers include increasing demand from the healthcare and pharmaceutical industries, the processed food segment, and growing awareness of sustainable and natural products.

What is the projected growth rate of the pharmaceutical-grade sodium bicarbonate market?

The pharmaceutical-grade sodium bicarbonate market is projected to grow at a CAGR of 3.5% from 2023 to 2034.

Which regions are expected to drive the growth of the sodium bicarbonate market?

India, China, and the U.S. are expected to be significant drivers of market growth due to their expanding pharmaceutical and food processing sectors.

Sources

1. ANZICS: SODa-BIC RCT - ANZICS.
2. Future Market Insights: Sodium Bicarbonate Market Share, Trend & Forecast 2033.
3. GlobeNewswire: Rising Usage of Sodium Bicarbonate in Cleansing Solutions and Systemic Alkalizer to Surge Pharma Grade Sodium Bicarbonate Market at 3.5% CAGR by 2034.
4. NPEU: Information for Clinicians | BASE | NPEU.

Last updated: 2024-12-31