CLINICAL TRIALS PROFILE FOR TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

All Clinical Trials for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00038402 ↗	Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer	Completed	Genentech, Inc.	Phase 3	2001-04-01	The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer. Other objectives: 1) to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, and 4) evaluate significance of HER2 expression by two different methods.
NCT00038402 ↗	Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer	Completed	M.D. Anderson Cancer Center	Phase 3	2001-04-01	The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer. Other objectives: 1) to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, and 4) evaluate significance of HER2 expression by two different methods.
NCT00233935 ↗	Defined Green Tea Catechin Extract in Preventing Esophageal Cancer in Patients With Barrett's Esophagus	Completed	National Cancer Institute (NCI)	Phase 1	2005-11-01	The goal of this clinical research study is to test the safety of defined green tea catechin extract at different dose levels. Researchers also want to find out what effects, good and bad, it may have on individual and their risk for esophagus cancer. Esophagus cancer is an increased risk associated with Barrett's esophagus. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of defined green tea catechin extract may prevent esophageal cancer.
NCT01256879 ↗	Cimetidine Biowaivers	Completed	Food and Drug Administration (FDA)	Phase 4	2011-03-01	The purpose of this research is to see if non-drug ingredients in capsules and oral solutions affect how well drugs are absorbed. This is called "bioequivalence." Medications taken by mouth, such as capsules and solutions, need to be absorbed into the body in order to do any good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are called excipients or fillers. Excipients in the capsules and solutions can impact how much drug is absorbed into the body. This is called "bioINequivalence." Capsules and solutions in this research contain the drug cimetidine. This drug is being used since it has high water solubility (can dissolve in water) and low ability to be absorbed.
NCT01256879 ↗	Cimetidine Biowaivers	Completed	University of Maryland	Phase 4	2011-03-01	The purpose of this research is to see if non-drug ingredients in capsules and oral solutions affect how well drugs are absorbed. This is called "bioequivalence." Medications taken by mouth, such as capsules and solutions, need to be absorbed into the body in order to do any good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are called excipients or fillers. Excipients in the capsules and solutions can impact how much drug is absorbed into the body. This is called "bioINequivalence." Capsules and solutions in this research contain the drug cimetidine. This drug is being used since it has high water solubility (can dissolve in water) and low ability to be absorbed.

Clinical Trial Conditions for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container

Condition Name

Condition Name for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container
Intervention	Trials
Anatomic Stage IV Breast Cancer AJCC v8	1
Prognostic Stage IB Breast Cancer AJCC v8	1
Anatomic Stage I Breast Cancer AJCC v8	1
Barrett Esophagus	1

Condition MeSH

Condition MeSH for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container
Intervention	Trials
Breast Neoplasms	2
Breast Carcinoma In Situ	1
Ulcer	1
Barrett Esophagus	1

Clinical Trial Locations for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container

Trials by Country

Trials by Country for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container
Location	Trials
United States	7
China	1

Trials by US State

Trials by US State for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container
Location	Trials
Washington	2
Texas	2
Ohio	1
Maryland	1
New York	1

Clinical Trial Progress for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container
Clinical Trial Phase	Trials
Completed	4
Recruiting	3

Clinical Trial Sponsors for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container

Sponsor Name

Sponsor Name for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container
Sponsor	Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2
Food and Drug Administration (FDA)	1
University of Maryland	1

Sponsor Type

Sponsor Type for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container
Sponsor	Trials
Other	6
NIH	4
Industry	2

TAGAMET Hydrochloride in Sodium Chloride 0.9%: Clinical Trials, Market Analysis, and Projections

Introduction

TAGAMET, known generically as cimetidine, is a potent H2-receptor antagonist used to treat various conditions associated with acid peptic digestion in the gastrointestinal tract. When administered in a solution of sodium chloride 0.9% in a plastic container, it offers a convenient and stable formulation for intravenous use. Here, we will delve into the clinical trials, market analysis, and projections for this specific formulation.

Clinical Trials and Efficacy

Healing Rates and Symptom Relief

Clinical trials have demonstrated the efficacy of cimetidine in healing ulcers and relieving symptoms of heartburn. A U.S. double-blind, placebo-controlled, dose-ranging study showed that once-daily at bedtime regimens of cimetidine were superior to placebo in ulcer healing. Specifically, the 800 mg at bedtime regimen healed 75% of patients at four weeks, which was significantly superior to the 400 mg at bedtime regimen and not significantly different from the 1600 mg at bedtime regimen[1].

Comparative Regimens

Studies comparing different dosing regimens (e.g., 800 mg b.i.d., 400 mg q.i.d.) have shown that cimetidine is effective in improving symptoms of day- and night-time heartburn, with many differences being statistically significant. The q.i.d. regimen was generally somewhat better than the b.i.d. regimen where these were compared[1].

Pathological Hypersecretory Conditions

Cimetidine has also been effective in treating pathological hypersecretory conditions such as Zollinger-Ellison Syndrome, further highlighting its broad therapeutic utility[1].

Safety and Adverse Reactions

Common Adverse Effects

While cimetidine has shown encouraging preliminary results with minimal adverse reactions, long-term use effects are still under observation. Common adverse effects include gynecomastia, which may be related to its weak antiandrogenic effect, and dose-related increases in serum transaminase levels. These liver enzyme elevations are usually reversible and do not progress with continued therapy[1].

Rare but Serious Adverse Effects

Rare cases of pancreatitis, allergic reactions including anaphylaxis, and hypersensitivity vasculitis have been reported. These conditions typically resolve upon withdrawal of the drug[1].

Market Analysis

Sodium Chloride Market Overview

The sodium chloride market, which is crucial for the formulation of TAGAMET Hydrochloride in Sodium Chloride 0.9%, is expected to grow significantly. The global sodium chloride market was valued at US$ 18.0 billion in 2022 and is projected to reach US$ 26.1 billion by 2031, growing at a CAGR of 3.8% from 2023 to 2031. This growth is driven by increasing demand in the food processing, pharmaceutical, and chemical sectors[2].

Pharmaceutical-Grade Sodium Chloride

The pharmaceutical-grade sodium chloride market, specifically, is anticipated to be worth USD 355 million in 2024 and is projected to reach USD 618 million by 2034, growing at a CAGR of 5.70%. This growth is fueled by the increasing consumption of pharmaceutical-grade sodium chloride for various applications, including the treatment of chronic and renal disorders[5].

Market Projections

Demand Drivers

The demand for TAGAMET Hydrochloride in Sodium Chloride 0.9% is expected to be driven by several factors:

• Increasing Prevalence of Gastrointestinal Disorders: The rising incidence of conditions like peptic ulcers and gastroesophageal reflux disease (GERD) will continue to drive the demand for effective treatments like cimetidine.
• Advancements in Formulation: The use of sodium chloride 0.9% in plastic containers enhances the stability and convenience of cimetidine administration, making it more appealing to healthcare providers and patients.
• Expansion of Healthcare Sector: The growing healthcare sector, particularly in emerging markets, will increase the demand for pharmaceutical-grade sodium chloride and cimetidine formulations[2][5].

Regional Market Growth

The market for TAGAMET Hydrochloride in Sodium Chloride 0.9% is expected to grow across various regions:

• North America and Europe: These regions are expected to maintain a significant share of the market due to the presence of key manufacturers and well-established industrial infrastructure[2].
• Asia Pacific, Latin America, and Middle East & Africa: These regions are considered emerging markets with steady growth in the chemical and food & beverage sectors, which will augment the market dynamics for sodium chloride and cimetidine formulations[2].

Key Takeaways

• Clinical Efficacy: Cimetidine has been shown to be highly effective in healing ulcers and relieving symptoms of heartburn in various clinical trials.
• Safety Profile: While generally safe, cimetidine can have rare but serious adverse effects, and long-term use effects are still under observation.
• Market Growth: The sodium chloride market and pharmaceutical-grade sodium chloride market are expected to grow significantly, driven by increasing demand in food processing, pharmaceuticals, and other sectors.
• Regional Expansion: The market for TAGAMET Hydrochloride in Sodium Chloride 0.9% is expected to grow across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

FAQs

What is the primary use of TAGAMET Hydrochloride in Sodium Chloride 0.9%?

TAGAMET Hydrochloride in Sodium Chloride 0.9% is primarily used to treat conditions associated with acid peptic digestion in the gastrointestinal tract, such as peptic ulcers and GERD.

What are the common dosing regimens for cimetidine?

Common dosing regimens include 300 mg q.i.d., 400 mg b.i.d., 800 mg h.s., and 1600 mg h.s., with the 800 mg h.s. regimen being particularly effective in clinical trials[1].

What are the potential adverse effects of cimetidine?

Potential adverse effects include gynecomastia, dose-related increases in serum transaminase levels, pancreatitis, allergic reactions, and hypersensitivity vasculitis[1].

How is the sodium chloride market expected to grow?

The global sodium chloride market is expected to grow at a CAGR of 3.8% from 2023 to 2031, reaching US$ 26.1 billion by the end of 2031[2].

What drives the demand for pharmaceutical-grade sodium chloride?

The demand is driven by increasing consumption for various applications, including the treatment of chronic and renal disorders, and the expansion of the healthcare sector[5].

Which regions are expected to see significant market growth for TAGAMET Hydrochloride in Sodium Chloride 0.9%?

North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa are expected to see significant market growth due to various demand drivers and regional market dynamics[2][5].

Sources

1. Drugs.com: Cimetidine: Package Insert / Prescribing Information.
2. Transparency Market Research: Sodium Chloride Market Size, Share & Growth Analysis 2031.
3. Baxter: USHP Supply Availability Report - March 12th, 2024.
4. JAMA Network: Evaluation of Cimetidine (Tagamet): An Antagonist of Hydrochloric Acid Secretion.
5. Accesswire: Pharmaceutical Grade Sodium Chloride Market Expected to Reach USD 618 million by 2034.

Last updated: 2025-01-03