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Last Updated: February 24, 2020

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CLINICAL TRIALS PROFILE FOR ZINC SULFATE

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505(b)(2) Clinical Trials for Zinc Sulfate

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
New Dosage NCT00266786 Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery Completed Luitpold Pharmaceuticals Phase 3 2005-12-01 Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when their pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, patients will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, patients will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Patients will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
OTC NCT01067547 A Trial of Iron Replacement in Patients With Iron Deficiency. Completed Richard Fedorak Phase 4 2010-03-01 Primary Hypothesis: There is no difference in the efficacy of iron replacement by oral or intravenous route in Inflammatory Bowel Disease patients. Iron deficiency anaemia is a common problem in people with inflammatory bowel disease (IBD) and patients with excessive blood loss from the bowel or heavy menstrual loss. Treatment options include a blood transfusion, oral iron with (Ferrograd ®) or intravenous iron replacement with iron sucrose (Venofer®). Iron deficiency anaemia is associated with poor quality of life, poor concentration span and low energy level. Blood transfusion may improve symptomatic anaemia quickly but there is a risk of transfusion reaction and blood born infection transmission. Moreover, packed cells are scarce resource therefore its use needs to be carefully prioritized. Oral iron supplement has been widely used and it can be purchased over the counter, however, its efficacy is not known in IBD population. Oral iron is poorly tolerated with side effects include altered bowel habit, nausea and darken stools, making it difficult to adhere to. In contrast, intravenous iron therapy with Venofer® has been shown to replenish iron store and improve anaemia quickly. To date, the safety of Venofer® use has been supported by its post marketing surveillance. Limitations with intravenous iron replacement include the need for medical supervision in the setting of limited healthcare resources; the need for patients to take multiple days off work and the cost of Venofer®. Currently it is uncertain which method of iron replacement is better. The purpose of this study is to compare the efficacy and the cost of oral and intravenous iron replacement in the setting of iron deficiency anaemia.
New Formulation NCT01893905 Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis Completed Tedec-Meiji Farma, S.A. Phase 3 2013-06-01 The main objective is to assess the efficacy of a new formulation containing chondroitin sulfate and glucosamine sulfate (CS+GS) compared with placebo in patients with primary osteoarthritis of the knee.
OTC NCT02189889 Active Preoperative Anemia Management in Patients Undergoing Cardiac Surgery Recruiting AMAG Pharmaceuticals, Inc. Phase 1/Phase 2 2013-04-01 Anemia which is a decreased blood count or lower than normal hemoglobin (hgb), is a major health problem for patients having heart surgery. Hemoglobin is the part of our blood that carries oxygen from the lungs to the rest of the body. Anemia that is present before surgery, called preoperative anemia, is a risk factor for an increased chance of morbidity (illness) and/or mortality (death) after heart surgery. It is also an important indicator of blood transfusion necessity. Recent clinical research investigations done to study preoperative anemia suggest a blood transfusion can damage the immune system (the system that protects us from disease) which can lead to infection, organ dysfunction (especially of the heart, kidney, brain), prolonged hospital stays, as well as increased supplies, resources and cost in surgical patients. Comprehensive anemia management can reduce or eliminate the need for blood transfusions and provide better outcomes after surgery. Therefore, controlling anemia before surgery is extremely important, and could be a lifesaving measure. This pilot, feasibility study is being done for several reasons. First of all, it will test the the safety and effectiveness of using a short-course of two medications, erythropoietin (EPO) and Feraheme (iron given intravenously [IV]), to increase hemoglobin levels in order to improve preoperative anemia, reduce transfusions and lower postoperative complications in anemic patients undergoing heart surgery. Secondly, findings will be used to design a large randomized controlled trial (RCT). The RCT will establish a protocol to actively manage anemia before surgery, thus reducing transfusions during surgery and improving recovery afterwards. It will also help identify valuable information regarding what needs to be done for timely completion of the planned RCT. EPO is a medication approved by the Food and Drug Administration (FDA) used to treat anemia in patients with certain conditions in order to reduce blood transfusions. And although approved for use during surgery, it has not been FDA approved for use in cardiac (heart) or vascular (blood vessels, including veins and arteries) surgery. Common side effects include nausea, vomiting, itching, headache, injection site pain, chills, deep vein thrombosis (blood clot), cough, and changes in blood pressure (BP). Feraheme is an iron replacement product approved for the treatment of low iron anemia in adult patients. It may cause serious allergic reactions, including anaphylaxis (severe, whole body allergic reaction), as well as low BP and excessive iron storage. Patients meeting all eligibility requirements that consent to participate will be randomized into the study. Randomization is being placed by chance (like a flip of a coin) into one of two study groups, the treatment group or the control group. There is an equal chance of being placed into either group, which will be done by a computer. 1. The Treatment Group will receive a 300 unit (U) per kilogram (kg) injection of EPO and a 510 milligram (mg) IV infusion of Feraheme 7-28 days before the day of surgery. And again 1-7 days before the day of surgery, a second dose of both of these medications will be given. The third dose, of EPO only, will be administered 2 days after surgery. Before initiating a dose or giving a subsequent dose, laboratory parameters will be measured to assess the hemoglobin level and response to the medication. If blood values increase too rapidly or are too high, the meds will not be started or, if already dosed, they will not be given again. 2. The Control Group will receive no preoperative intervention for anemia unless lab results show iron deficiency anemia. The control group will be screened for the presence of iron deficiency anemia by evaluating blood laboratory values drawn during the baseline or preoperative visit. If lab results indicate iron deficiency anemia, over-the-counter oral iron will be recommended, to take until the day of surgery. In doing so, patients may benefit by potentially reducing the need for blood transfusions. Data will be collected from all participants from the preoperative visits throughout the admission, including lab results, medications, vital signs, information about the procedure, transfusions, and any problems or adverse events.
OTC NCT02189889 Active Preoperative Anemia Management in Patients Undergoing Cardiac Surgery Recruiting University of Texas Southwestern Medical Center Phase 1/Phase 2 2013-04-01 Anemia which is a decreased blood count or lower than normal hemoglobin (hgb), is a major health problem for patients having heart surgery. Hemoglobin is the part of our blood that carries oxygen from the lungs to the rest of the body. Anemia that is present before surgery, called preoperative anemia, is a risk factor for an increased chance of morbidity (illness) and/or mortality (death) after heart surgery. It is also an important indicator of blood transfusion necessity. Recent clinical research investigations done to study preoperative anemia suggest a blood transfusion can damage the immune system (the system that protects us from disease) which can lead to infection, organ dysfunction (especially of the heart, kidney, brain), prolonged hospital stays, as well as increased supplies, resources and cost in surgical patients. Comprehensive anemia management can reduce or eliminate the need for blood transfusions and provide better outcomes after surgery. Therefore, controlling anemia before surgery is extremely important, and could be a lifesaving measure. This pilot, feasibility study is being done for several reasons. First of all, it will test the the safety and effectiveness of using a short-course of two medications, erythropoietin (EPO) and Feraheme (iron given intravenously [IV]), to increase hemoglobin levels in order to improve preoperative anemia, reduce transfusions and lower postoperative complications in anemic patients undergoing heart surgery. Secondly, findings will be used to design a large randomized controlled trial (RCT). The RCT will establish a protocol to actively manage anemia before surgery, thus reducing transfusions during surgery and improving recovery afterwards. It will also help identify valuable information regarding what needs to be done for timely completion of the planned RCT. EPO is a medication approved by the Food and Drug Administration (FDA) used to treat anemia in patients with certain conditions in order to reduce blood transfusions. And although approved for use during surgery, it has not been FDA approved for use in cardiac (heart) or vascular (blood vessels, including veins and arteries) surgery. Common side effects include nausea, vomiting, itching, headache, injection site pain, chills, deep vein thrombosis (blood clot), cough, and changes in blood pressure (BP). Feraheme is an iron replacement product approved for the treatment of low iron anemia in adult patients. It may cause serious allergic reactions, including anaphylaxis (severe, whole body allergic reaction), as well as low BP and excessive iron storage. Patients meeting all eligibility requirements that consent to participate will be randomized into the study. Randomization is being placed by chance (like a flip of a coin) into one of two study groups, the treatment group or the control group. There is an equal chance of being placed into either group, which will be done by a computer. 1. The Treatment Group will receive a 300 unit (U) per kilogram (kg) injection of EPO and a 510 milligram (mg) IV infusion of Feraheme 7-28 days before the day of surgery. And again 1-7 days before the day of surgery, a second dose of both of these medications will be given. The third dose, of EPO only, will be administered 2 days after surgery. Before initiating a dose or giving a subsequent dose, laboratory parameters will be measured to assess the hemoglobin level and response to the medication. If blood values increase too rapidly or are too high, the meds will not be started or, if already dosed, they will not be given again. 2. The Control Group will receive no preoperative intervention for anemia unless lab results show iron deficiency anemia. The control group will be screened for the presence of iron deficiency anemia by evaluating blood laboratory values drawn during the baseline or preoperative visit. If lab results indicate iron deficiency anemia, over-the-counter oral iron will be recommended, to take until the day of surgery. In doing so, patients may benefit by potentially reducing the need for blood transfusions. Data will be collected from all participants from the preoperative visits throughout the admission, including lab results, medications, vital signs, information about the procedure, transfusions, and any problems or adverse events.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Zinc Sulfate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000304 Dextroamphetamine as an Adjunct in Cocaine Treatment - 1 Completed University of Texas Phase 2 1997-08-01 The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in cocaine treatment; an evaluation of the ""replacement"" strategy.
NCT00000304 Dextroamphetamine as an Adjunct in Cocaine Treatment - 1 Completed National Institute on Drug Abuse (NIDA) Phase 2 1997-08-01 The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in cocaine treatment; an evaluation of the ""replacement"" strategy.
NCT00000306 Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3 Completed University of Texas Phase 2 1994-09-01 The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients.
NCT00000306 Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3 Completed National Institute on Drug Abuse (NIDA) Phase 2 1994-09-01 The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients.
NCT00000579 Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1994-09-01 The purposes of this study are to assess rapidly innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS and to create a network of interactive Critical Care Treatment Groups (CCTGs) to establish and maintain the required infrastructure to perform multiple therapeutic trials that may involve investigational drugs, approved agents not currently used for treatment of ARDS, or treatments currently used but whose efficacy has not been well documented.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zinc Sulfate

Condition Name

Condition Name for Zinc Sulfate
Intervention Trials
Pain 36
HIV Infections 35
Healthy 30
Postoperative Pain 22
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Condition MeSH

Condition MeSH for Zinc Sulfate
Intervention Trials
Lymphoma 67
Leukemia 46
HIV Infections 44
Precursor Cell Lymphoblastic Leukemia-Lymphoma 44
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Clinical Trial Locations for Zinc Sulfate

Trials by Country

Trials by Country for Zinc Sulfate
Location Trials
Canada 214
Australia 74
Egypt 46
Brazil 37
China 34
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Trials by US State

Trials by US State for Zinc Sulfate
Location Trials
California 141
New York 127
Texas 116
Pennsylvania 111
Illinois 102
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Clinical Trial Progress for Zinc Sulfate

Clinical Trial Phase

Clinical Trial Phase for Zinc Sulfate
Clinical Trial Phase Trials
Phase 4 136
Phase 3 164
Phase 2/Phase 3 26
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Clinical Trial Status

Clinical Trial Status for Zinc Sulfate
Clinical Trial Phase Trials
Completed 332
Recruiting 175
Not yet recruiting 111
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Clinical Trial Sponsors for Zinc Sulfate

Sponsor Name

Sponsor Name for Zinc Sulfate
Sponsor Trials
National Cancer Institute (NCI) 133
Assiut University 22
Children's Oncology Group 21
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Sponsor Type

Sponsor Type for Zinc Sulfate
Sponsor Trials
Other 655
Industry 293
NIH 170
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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Boehringer Ingelheim
Mallinckrodt
Harvard Business School
Baxter

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