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CLINICAL TRIALS PROFILE FOR RANITIDINE HYDROCHLORIDE

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505(b)(2) Clinical Trials for Ranitidine Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

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Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00443963	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-Steroidal Anti-Inflammatory Drugs	Terminated	AstraZeneca	Phase 4	2006-12-01	We hypothesize that patients receiving NSAID drugs with dyspeptic symptoms have increased production of gastric levels of free radicals. The primary objective of the study is to determine if Esomeprazole Magnesium increases gastric total antioxidant capacity and decreases gastric free radical production in humans. Patients (age 18 years and older) with no history of upper GI bleeding who are receiving non-steroidal anti-inflammatory drugs and then develop dyspepsia will be recruited from our primary care clinic in Washington, DC. All eligible individuals will undergo biopsies of antrum and corpus. The subjects will be randomized to receive either Zantac OTC or Nexium for 15 days. On day 15, all patients will undergo repeat upper endoscopy to obtain biopsies of antrum and corpus. Tissue samples will then be extracted to determine total antioxidant capacity and lipid peroxide levels (as an indirect marker of free radical production).
OTC	NCT00443963	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-Steroidal Anti-Inflammatory Drugs	Terminated	Medstar Health Research Institute	Phase 4	2006-12-01	We hypothesize that patients receiving NSAID drugs with dyspeptic symptoms have increased production of gastric levels of free radicals. The primary objective of the study is to determine if Esomeprazole Magnesium increases gastric total antioxidant capacity and decreases gastric free radical production in humans. Patients (age 18 years and older) with no history of upper GI bleeding who are receiving non-steroidal anti-inflammatory drugs and then develop dyspepsia will be recruited from our primary care clinic in Washington, DC. All eligible individuals will undergo biopsies of antrum and corpus. The subjects will be randomized to receive either Zantac OTC or Nexium for 15 days. On day 15, all patients will undergo repeat upper endoscopy to obtain biopsies of antrum and corpus. Tissue samples will then be extracted to determine total antioxidant capacity and lipid peroxide levels (as an indirect marker of free radical production).
OTC	NCT03145012	Histamine Receptor 2 Antagonists as Enhancers of Anti-Tumour Immunity	Not yet recruiting	Dalhousie University	Phase 4	2018-03-01	The immune response against tumors can be highly effective in preventing tumor development, growth and metastasis under certain circumstances. However, tumor associated immune suppression can profoundly limit the impact of natural tumor immunity and also reduce the effectiveness of tumor immunotherapy strategies. A major component of tumor associated immune suppression is mediated by myeloid cells, especially the monocytic subset of myeloid derived suppressor cells (MDSC). In recent studies that were conducted through a CCSRI Innovation grant, the investigators discovered that oral treatment of mice with the commonly used histamine receptor 2 (H2) antagonists ranitidine or famotidine inhibits both primary breast tumor development and metastasis, in three distinct mouse tumor models and reduces the numbers of monocytic MDSC. These findings have enormous potential to aid in effective cancer immunotherapy and may have immediate implications for cancer patients. The objective of this investigation is to determine whether treatment with the H2 receptor antagonist ranitidine alters immune suppression, through modulation of immune cell populations. The investigators will examine peripheral blood monocyte, neutrophil and NK cell numbers, subsets and activation status from healthy volunteers treated for 6 weeks with daily oral ranitidine. Ranitidine is widely available and used over the counter in Canada. These drugs are widely recognized as safe, well tolerated and have very few side effects. It has been suggested that among the general population, over 10% of those over the age of 65 take such medications on a regular basis for relief against gastrointestinal discomfort. The outcome of pre-clinical studies in mice warrant further investigation into transferability to humans. If the outcome of the current proposal proves to be viable, then these drugs could provide a safe method to reduce tumor associated immunosuppression with broad implications, both for current cancer patients and for those at high risk of developing cancer. Further to this, the outcome of our proposal may provide a new strategy for improving the effectiveness of T-cell mediated immunotherapy.
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All Clinical Trials for Ranitidine Hydrochloride

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000964	The Effect of Stomach Acid on Foscarnet	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To see if ranitidine, by reducing stomach acidity, can enhance the effectiveness of foscarnet, by making foscarnet more available to the body. Foscarnet is an antiviral compound. Laboratory studies have shown it to be active against HIV. However, only 12 - 22 percent of an oral foscarnet dose is absorbed by the body. Ranitidine suppresses gastric acid output, increasing gastric pH. Thus by increasing gastric pH (decreasing stomach acidity), less foscarnet is expected to be decomposed or broken down in the stomach. Thus, more foscarnet should be absorbed into the body.
NCT00002106	A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter Trial to Evaluate the Effect of Ranitidine on Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects With a CD4 Cell Count Between 400-700 Cells/mm3	Completed	Glaxo Wellcome	Phase 2	1969-12-31	To evaluate the effect of ranitidine on immunologic indicators in asymptomatic HIV-1 infected patients with CD4 counts of 400-700 cells/mm3.
NCT00037570	Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 2	2000-11-01	This is a multicenter, randomized, double-blind, parallel-group, dose-ranging, comparator-controlled study of the effect of pantoprazole on intragastric pH after successful endoscopic hemostasis in hospitalized patients. Patients will receive either intravenous pantoprazole (one of two regimens) or ranitidine (the comparator) within 2 hours of successful hemostasis and administration will continue for 72 hours after hemostasis.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary