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
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.

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	3
Gastric Cancer	2
Non-Genital Warts	2

Condition MeSH

Condition MeSH for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Breast Neoplasms	4
Warts	4
Carcinoma	3
Infections	3

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

Trials by Country

Trials by Country for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
United States	85
China	10
Germany	5
Egypt	3
Canada	2

Trials by US State

Trials by US State for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
Texas	13
Florida	4
Massachusetts	4
Washington	4
Illinois	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
PHASE2	1
PHASE1	1
Phase 4	10

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	6
Genentech, Inc.	4

Sponsor Type

Sponsor Type for CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
Other	64
Industry	36
NIH	4

Last updated: May 27, 2026

Cimetidine Hydrochloride in Sodium Chloride 0.9% in Plastic Container: Clinical Trials Update, Market Analysis, and Launch-Projections

What clinical trials are active or completed for cimetidine hydrochloride in sodium chloride 0.9% (plastic container)?

No complete, citable dataset is available here to identify trial registries (e.g., ClinicalTrials.gov), match the specific combination product (“cimetidine hydrochloride in sodium chloride 0.9% in plastic container”), and summarize status by phase with regulatory milestones.

How is the market structured for IV cimetidine in 0.9% saline plastic containers?

No complete, citable dataset is available here to quantify the addressable market for this exact dosage form (IV admixture: cimetidine HCl in 0.9% NaCl) in plastic containers, by geography, channel (hospital vs retail), and payer category.

What is the revenue outlook and pricing trajectory for IV cimetidine HCl in 0.9% saline plastic containers?

No complete, citable dataset is available here to provide credible projections for unit sales, ASP/WAC trends, or reimbursement shifts for this exact product configuration.

When will exclusivity and patents block or permit generic entry for this specific IV formulation?

No complete, citable Orange Book/patent-registry mapping is available here that ties exclusivity and patent status to the exact FDA product listing for “cimetidine hydrochloride in sodium chloride 0.9% in plastic container.”

Are there Paragraph IV or biosimilar-style risks for IV cimetidine hydrochloride in saline?

No complete, citable dataset is available here to document Paragraph IV filings, court cases, or settlement agreements for this specific product and container presentation.

How competitive is this product versus famotidine and other H2 antagonists (IV saline)?

No complete, citable dataset is available here to compare competitive penetration and interchangeability impacts versus other H2 blockers for the IV setting (including relative formulary position, utilization drivers, and adverse event or guideline shifts) for the exact saline-in-plastic presentation.

What manufacturing and container-related IP or regulatory constraints affect supply?

No complete, citable dataset is available here to identify container-specific regulatory hurdles (e.g., plasticizer/extractables, stability by container type) or any formulation/manufacturing IP that would affect supply continuity for this product presentation.

What is the safest commercialization timeline for new entrants based on FDA and trial-readiness?

No complete, citable dataset is available here to map FDA regulatory status, facility readiness, stability package sufficiency, and clinical bridging requirements for this exact product form.

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Key Takeaways

• A market and clinical-trial projection requires product-specific, citable mapping to FDA listings, patent/exclusivity status, and trial registry records for “cimetidine hydrochloride in sodium chloride 0.9% in plastic container.”
• No sufficient source-backed information is present in this workspace to produce accurate clinical updates, market sizing, or forecasted launch/exclusivity outcomes for this exact formulation and packaging.

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FAQs

1. What FDA submission type applies to generic versions of cimetidine HCl IV in 0.9% saline plastic containers?
2. How do container materials (plastic vs glass) affect IV stability for cimetidine-saline admixtures?
3. What are the typical IV indications driving cimetidine utilization in hospitals?
4. How does formulary preference between cimetidine and famotidine shift IV demand?
5. What data requirements (bridging vs full trials) are commonly demanded for IV H2 antagonist generics?

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References (APA)

No sources cited.