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

All Clinical Trials for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00050167 ↗	Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer	Completed	Roche Pharma AG	Phase 1	2002-11-01	Primary Objectives: - Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer. - Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly paclitaxel. - Determine the ability of each regimen to enhance breast conservation therapy when administered in the neoadjuvant setting. (See protocol text for additional objectives and details).
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.
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.
NCT00002733 ↗	Biological Therapy in Treating Patients With Metastatic Cancer	Completed	Hoag Memorial Hospital Presbyterian	Phase 2	1996-01-01	RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies, including interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of biological therapies, including interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, in treating patients with metastatic cancer.
NCT00002092 ↗	A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection	Completed	Community Research Initiative of New England	N/A	1969-12-31	To determine the change in CD4 count after 4 and 8 weeks in HIV-infected patients treated with cimetidine compared to placebo. To observe time-associated trends at weeks 4, 8, 12, and 16 in the change of CD4 counts for patients taking cimetidine for the full 16 weeks. To establish a safety record for cimetidine use in HIV-positive patients.

Clinical Trial Conditions for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Condition Name

Condition Name for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Healthy	5
Breast Cancer	2
Rectal Cancer	2
Gastric Cancer	2

Condition MeSH

Condition MeSH for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Carcinoma	3
Infections	3
Breast Neoplasms	3
Warts	3

Clinical Trial Locations for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trials by Country

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Trials by Country for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
United States	85
China	9
Germany	5
France	2
Ireland	2

Trials by US State

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Trials by US State for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
Texas	13
Washington	4
Florida	4
Massachusetts	4
Pennsylvania	3

Clinical Trial Progress for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	10
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	34
Unknown status	12
Recruiting	8

Clinical Trial Sponsors for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
M.D. Anderson Cancer Center	9
Assiut University	5
Genentech, Inc.	4

Sponsor Type

Sponsor Type for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
Other	61
Industry	35
NIH	4

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

Introduction

Cimetidine hydrochloride, a histamine H2-receptor antagonist, is widely used in the treatment of various gastrointestinal disorders, including peptic ulcers, gastroesophageal reflux disease (GERD), and pathological hypersecretory conditions. Here, we will delve into the clinical trials, market analysis, and future projections for cimetidine hydrochloride, particularly when administered in a sodium chloride 0.9% solution.

Clinical Trials Overview

Efficacy in Duodenal Ulcers

Clinical trials have consistently shown the efficacy of cimetidine in treating active duodenal ulcers. Studies involving cimetidine tablets have demonstrated significant healing rates compared to placebo. For instance, trials where patients were administered 800 mg of cimetidine twice daily or 400 mg four times daily showed healing rates of 45% to 67% by week 12, which were statistically superior to placebo[1].

Symptom Relief

Cimetidine has also been effective in improving symptoms of day- and night-time heartburn. The twice-daily and four-times-daily regimens were both effective, with the four-times-daily regimen showing slightly better results in some comparisons[1].

Maintenance Therapy

In addition to treating active ulcers, cimetidine has been used in maintenance therapy to prevent the recurrence of gastric and duodenal ulcers. This has been particularly beneficial in patients with a history of recurrent ulcers[1].

Mechanism of Action and Pharmacology

Histamine H2-Receptor Antagonism

Cimetidine works by competitively inhibiting the action of histamine at the histamine H2 receptors of the parietal cells in the stomach. This inhibition reduces both basal and stimulated gastric acid secretion, including secretion stimulated by food, caffeine, insulin, betazole, and pentagastrin[1][4].

Pharmacokinetics

Cimetidine is absorbed orally, with an absolute bioavailability of approximately 60% in healthy patients, which can be higher in patients with peptic ulcer disease. It is primarily excreted in the urine, with a half-life of around 2 hours[4].

Market Analysis

Current Market

The market for cimetidine, including its formulations in sodium chloride solutions, has been stable due to its established use in treating gastrointestinal disorders. In North America, the market for cimetidine was valued at several million USD in 2023 and is expected to grow at a significant Compound Annual Growth Rate (CAGR) through 2030[5].

Competitive Landscape

Cimetidine faces competition from other H2-receptor antagonists and proton pump inhibitors (PPIs), which are also used to treat similar conditions. However, its long history of use and generic availability have maintained its market presence[4].

Projections and Future Outlook

Growing Demand

The demand for cimetidine is expected to continue due to the prevalence of gastrointestinal disorders. The increasing incidence of GERD and peptic ulcers, particularly in aging populations and those with lifestyle factors contributing to these conditions, will drive the market growth[5].

Generic and Branded Formulations

The availability of both generic and branded formulations of cimetidine will continue to influence market dynamics. Generic versions, such as those from various manufacturers, will likely remain a significant portion of the market, while branded versions like Tagamet will maintain their niche based on brand loyalty and specific indications[4].

Innovations in Delivery

The formulation of cimetidine in a sodium chloride 0.9% solution, often used for intravenous administration, may see innovations in delivery systems to enhance patient compliance and ease of administration. This could include pre-mixed solutions in plastic containers, which simplify the preparation process for healthcare providers[1].

Quality Control and Analysis

Qualitative and Quantitative Analysis

Ensuring the quality of cimetidine formulations is crucial. Studies have developed and validated ultraviolet spectrophotometric methods for the qualitative and quantitative analysis of cimetidine in tablet preparations, which can also be applied to solutions. These methods ensure the efficacy, safety, and quality of the drug[2].

Adverse Effects and Safety

Common Adverse Effects

Cimetidine is generally well-tolerated, but it can cause adverse effects such as gynecomastia, particularly in patients treated for pathological hypersecretory states, and reversible impotence in some cases. It also inhibits the cytochrome P-450 enzyme system, which can affect the metabolism of co-administered medications[1][4].

Long-Term Use

Long-term use of cimetidine has been associated with an increased incidence of benign Leydig cell tumors in animal studies, although this has not been conclusively linked to human use. Monitoring for potential endocrine dysfunction is recommended, especially in patients receiving high doses for extended periods[1].

Key Takeaways

• Clinical Efficacy: Cimetidine hydrochloride is effective in treating duodenal ulcers, GERD, and other gastrointestinal disorders.
• Mechanism of Action: It works by inhibiting histamine H2 receptors, reducing gastric acid secretion.
• Market Growth: The market for cimetidine is expected to grow significantly through 2030 due to the prevalence of gastrointestinal disorders.
• Quality Control: Ultraviolet spectrophotometric methods ensure the quality and efficacy of cimetidine formulations.
• Safety Profile: While generally safe, cimetidine can cause adverse effects such as gynecomastia and reversible impotence, and it may interact with other medications.

FAQs

What is the primary mechanism of action of cimetidine hydrochloride?

Cimetidine hydrochloride works by competitively inhibiting the action of histamine at the histamine H2 receptors of the parietal cells, reducing gastric acid secretion.

What are the common indications for cimetidine hydrochloride?

Cimetidine is indicated for the treatment of duodenal ulcers, non-malignant gastric ulcers, GERD, and pathological hypersecretory conditions.

How is cimetidine hydrochloride administered?

Cimetidine can be administered orally in tablet form or intravenously in a sodium chloride 0.9% solution.

What are the potential adverse effects of long-term cimetidine use?

Long-term use can lead to gynecomastia, reversible impotence, and potential interactions with other medications due to its inhibition of the cytochrome P-450 enzyme system.

What is the expected market growth for cimetidine hydrochloride through 2030?

The market for cimetidine is expected to grow at a significant CAGR through 2030 due to the increasing prevalence of gastrointestinal disorders.

How is the quality of cimetidine formulations ensured?

The quality is ensured through qualitative and quantitative analysis using ultraviolet spectrophotometric methods.

Sources

1. Drugs.com: Cimetidine Tablets: Package Insert / Prescribing Info.
2. AIP: Qualitative and quantitative analysis of marketed cimetidine tablet preparations.
3. Gilead: VEKLURY® (remdesivir) for injection, for intravenous use (not directly relevant but included for context on drug administration).
4. DrugBank: Cimetidine: Uses, Interactions, Mechanism of Action.
5. DrugPatentWatch: Drug prices and trends for cimetidine.