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Last Updated: November 18, 2019

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CLINICAL TRIALS PROFILE FOR FAMOTIDINE

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505(b)(2) Clinical Trials for Famotidine

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
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.
OTC NCT03145012 Histamine Receptor 2 Antagonists as Enhancers of Anti-Tumour Immunity Not yet recruiting Nova Scotia Health Authority 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.
OTC NCT03145012 Histamine Receptor 2 Antagonists as Enhancers of Anti-Tumour Immunity Not yet recruiting Lisa Barrett 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Famotidine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00141960 Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease Completed Astellas Pharma Inc Phase 2/Phase 3 2005-09-01 Gastroesophageal reflux disease (GERD) considered to be associated with mucosal damages in the esophagus and heartburn, which may sometimes interfere with daily activities due likely to reflux of acid gastric contents. While most of the patients given the diagnosis of GERD do not exhibit endoscopically obvious impairment in esophageal mucous membrane, they have subjective symptoms of non-erosive GERD including heartburn. But no drug has been launched in Japan, which targets non-erosive GERD. This study will examine the efficacy and safety of famotidine in subjects with non-erosive GERD.
NCT00153673 Effect of Selective COX-2 Inhibition on Ulcer Healing Suspended Chinese University of Hong Kong Phase 3 2001-02-01 The purpose of this study is to compare the effect of Famotidine plus a COX-2 inhibitor (celecoxib) with Famotidine plus dologesics in ulcer healing in arthritis patients.
NCT00229424 Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine - Completed UCB Pharma Phase 3 2005-04-01 The purpose of the study is to verify superiority of the lafutidine group over the placebo group and non-inferiority to the famotidine group in terms of endoscopic healing rate of the patients with mild reflux oesophagitis. Furthermore, the followings are compared: The improvement effect in heartburn and other subjective symptoms, and dosing frequency of MALFA ® suspension (neutralizer) as well as incidence of adverse events among the lafutidine 20 mg/day treatment group, the famotidine 40 mg/day treatment group and the placebo treatment group in patients with mild reflux oesophagitis.
NCT00229424 Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine - Completed Taiho Pharmaceutical Co., Ltd. Phase 3 2005-04-01 The purpose of the study is to verify superiority of the lafutidine group over the placebo group and non-inferiority to the famotidine group in terms of endoscopic healing rate of the patients with mild reflux oesophagitis. Furthermore, the followings are compared: The improvement effect in heartburn and other subjective symptoms, and dosing frequency of MALFA ® suspension (neutralizer) as well as incidence of adverse events among the lafutidine 20 mg/day treatment group, the famotidine 40 mg/day treatment group and the placebo treatment group in patients with mild reflux oesophagitis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Famotidine

Condition Name

Condition Name for Famotidine
Intervention Trials
Healthy 5
Peptic Ulcer 4
HIV Infections 3
Cancer 3
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Condition MeSH

Condition MeSH for Famotidine
Intervention Trials
Ulcer 9
Peptic Ulcer 7
Carcinoma 4
Gastroesophageal Reflux 4
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Clinical Trial Locations for Famotidine

Trials by Country

Trials by Country for Famotidine
Location Trials
United States 47
China 16
Taiwan 9
Korea, Republic of 8
Canada 7
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Trials by US State

Trials by US State for Famotidine
Location Trials
Texas 11
California 6
Florida 4
Pennsylvania 4
Illinois 2
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Clinical Trial Progress for Famotidine

Clinical Trial Phase

Clinical Trial Phase for Famotidine
Clinical Trial Phase Trials
Phase 4 17
Phase 3 10
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Famotidine
Clinical Trial Phase Trials
Completed 36
Recruiting 12
Not yet recruiting 7
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Clinical Trial Sponsors for Famotidine

Sponsor Name

Sponsor Name for Famotidine
Sponsor Trials
M.D. Anderson Cancer Center 5
Horizon Pharma Ireland, Ltd., Dublin Ireland 5
Bristol-Myers Squibb 5
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Sponsor Type

Sponsor Type for Famotidine
Sponsor Trials
Other 49
Industry 35
NIH 2
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