CLINICAL TRIALS PROFILE FOR CIMETIDINE

All Clinical Trials for Cimetidine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
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.
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).

Clinical Trial Conditions for Cimetidine

Condition Name

Condition Name for Cimetidine
Intervention	Trials
Healthy	5
Rectal Cancer	2
Gastric Cancer	2
Breast Cancer	2

Condition MeSH

Condition MeSH for Cimetidine
Intervention	Trials
Warts	3
Carcinoma	3
Infections	3
Breast Neoplasms	3

Clinical Trial Locations for Cimetidine

Trials by Country

Trials by Country for Cimetidine
Location	Trials
United States	85
China	9
Germany	5
Israel	2
France	2

Trials by US State

Trials by US State for Cimetidine
Location	Trials
Texas	13
Massachusetts	4
Washington	4
Florida	4
California	3

Clinical Trial Progress for Cimetidine

Clinical Trial Phase

Clinical Trial Phase for Cimetidine
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	10
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Cimetidine
Clinical Trial Phase	Trials
Completed	34
Unknown status	12
Recruiting	8

Clinical Trial Sponsors for Cimetidine

Sponsor Name

Sponsor Name for Cimetidine
Sponsor	Trials
M.D. Anderson Cancer Center	9
Assiut University	5
Genentech, Inc.	4

Sponsor Type

Sponsor Type for Cimetidine
Sponsor	Trials
Other	61
Industry	35
NIH	4

Cimetidine: Clinical Trials, Market Analysis, and Projections

Introduction to Cimetidine

Cimetidine is a well-established histamine H2 receptor antagonist widely used to manage various gastrointestinal conditions, including duodenal ulcers, non-malignant gastric ulcers, gastroesophageal reflux disease (GERD), and pathological hypersecretion associated with conditions like Zollinger-Ellison Syndrome[4].

Clinical Trials Update

Efficacy and Safety in Protoporphyrias

A recent clinical trial, NCT05020184, is investigating the efficacy and safety of oral cimetidine in treating protoporphyrias, a group of rare genetic disorders characterized by the accumulation of protoporphyrin in the body. This study employs a prospective, blinded, randomized, 2x2 cross-over design, comparing cimetidine to a placebo in patients with protoporphyria. The trial aims to assess the impact of cimetidine on protoporphyrin levels, photosensitivity, and quality of life. If successful, this would be the first study to provide quality evidence for a disease-modifying therapy for erythropoietic protoporphyria (EPP) using an already approved drug with a favorable side effect profile[1].

Market Analysis

Global Market Overview

The global cimetidine market is segmented by region, type, and application. Key regions include North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The market is dominated by several major players, such as Union Quimico Farmaceutica, S.A., Apotex Pharmachem, Corden Pharma Bergamo Spa, and others[2][5].

Regional Market Performance

• North America: The North American market for cimetidine was valued at a significant amount in 2023 and is expected to grow at a certain CAGR through 2030.
• Europe: Similarly, the European market held a substantial value in 2023 and is projected to grow at a specific CAGR during the forecast period.
• Asia-Pacific: This region is anticipated to record a higher growth rate in the cimetidine market due to increasing demand and expanding healthcare infrastructure[2][5].

Market Segmentation by Type and Application

• Type: The market is segmented into different purity levels, such as 98% and 99% purity cimetidine.
• Application: Cimetidine is used in various forms, including tablet products, injection products, and capsules. Each application segment has its own market size and development potential[2].

Market Projections

Forecast and Growth Potential

The global cimetidine market is expected to grow significantly from 2024 to 2030. Here are some key projections:

• Revenue and Volume Forecast: The market is forecasted to increase in both sales volume and revenue, with detailed forecasts provided for each region and application segment[2].
• Growth Rate: The Asia-Pacific region is expected to exhibit the highest growth rate during the forecast period, driven by increasing healthcare needs and economic growth[5].

Competitive Landscape

The market is highly competitive, with the top five players holding a significant share of the global revenue. Companies like Union Quimico Farmaceutica, S.A., Apotex Pharmachem, and Hengdian Group are among the key players. The competitive landscape is analyzed in terms of market share, latest developments, mergers, and acquisitions[2][5].

Clinical Uses and Efficacy

Duodenal Ulcer Treatment

Cimetidine has been extensively proven to be effective in treating active duodenal ulcers. Clinical studies have shown that cimetidine accelerates the healing rate of duodenal ulcers, with healing rates of 79-85% reported in foreign double-blind studies after four weeks of treatment with 800 mg of cimetidine at bedtime[3].

Maintenance Therapy

Cimetidine is also effective as maintenance therapy to prevent the recurrence of duodenal ulcers. Studies have shown that treatment with a reduced dose of cimetidine (400 mg at bedtime) significantly lowers the percentage of patients with observed ulcers at the end of one year compared to placebo[3].

Other Clinical Uses

In addition to duodenal ulcers, cimetidine is used to treat active benign gastric ulcers, GERD, and other conditions associated with excessive gastric acid secretion. It has also been used in the management of cystic fibrosis in children and to treat NSAID-induced lesions and gastrointestinal symptoms[4].

Safety and Side Effects

While cimetidine is generally well-tolerated, it can have side effects such as decreased white blood cell counts, thrombocytopenia, and rare cases of immune hemolytic anemia. Long-term studies in rats have shown an increase in benign Leydig cell tumors at higher doses, although these findings are not directly applicable to humans[3].

Key Takeaways

• Clinical Trials: Cimetidine is being investigated for its potential in treating protoporphyrias, which could lead to a new therapeutic application.
• Market Growth: The global cimetidine market is expected to grow, particularly in the Asia-Pacific region.
• Clinical Efficacy: Cimetidine is highly effective in treating duodenal ulcers and other gastrointestinal conditions.
• Safety Profile: While generally safe, cimetidine can have rare but significant side effects that need monitoring.

FAQs

What is the primary use of cimetidine in clinical practice?

Cimetidine is primarily used to reduce gastric acid secretion and treat conditions such as duodenal ulcers, non-malignant gastric ulcers, and gastroesophageal reflux disease (GERD)[4].

What is the current status of the clinical trial on cimetidine for protoporphyrias?

The clinical trial (NCT05020184) is ongoing, aiming to determine the efficacy and safety of oral cimetidine in treating protoporphyrias through a prospective, blinded, randomized design[1].

Which regions are expected to drive the growth of the cimetidine market?

The Asia-Pacific region is anticipated to record the highest growth rate in the cimetidine market during the forecast period due to increasing healthcare needs and economic growth[5].

What are the common side effects of cimetidine?

Common side effects include decreased white blood cell counts, thrombocytopenia, and rare cases of immune hemolytic anemia. Long-term use can also be associated with an increased risk of certain tumors in animal studies[3].

Who are the major players in the global cimetidine market?

Key players include Union Quimico Farmaceutica, S.A., Apotex Pharmachem, Corden Pharma Bergamo Spa, Hengdian Group, and others[2][5].

Sources

1. CenterWatch: Effect of Oral Cimetidine in the Protoporphyrias.
2. QYResearch: Cimetidine - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030.
3. Drugs.com: Cimetidine Injection: Package Insert / Prescribing Info.
4. DrugBank: Cimetidine: Uses, Interactions, Mechanism of Action.
5. OpenPR: A Spotlight on Cimetidine Market from 2020 to 2025: Top Key Manufacturers.

Last updated: 2025-01-03