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Last Updated: January 19, 2022

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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 Egalet Ltd 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 the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects 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, subjects 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. Subjects 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.
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 the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects 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, subjects 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. Subjects 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.
>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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zinc Sulfate

Condition Name

Condition Name for Zinc Sulfate
Intervention Trials
Pain 37
HIV Infections 35
Healthy 32
Postoperative Pain 28
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Condition MeSH

Condition MeSH for Zinc Sulfate
Intervention Trials
Lymphoma 81
Leukemia 60
Precursor Cell Lymphoblastic Leukemia-Lymphoma 56
Leukemia, Lymphoid 56
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Clinical Trial Locations for Zinc Sulfate

Trials by Country

Trials by Country for Zinc Sulfate
Location Trials
United States 4,040
Canada 292
Australia 93
Egypt 78
Brazil 45
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Trials by US State

Trials by US State for Zinc Sulfate
Location Trials
California 181
Texas 166
New York 166
Pennsylvania 140
Ohio 139
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Clinical Trial Progress for Zinc Sulfate

Clinical Trial Phase

Clinical Trial Phase for Zinc Sulfate
Clinical Trial Phase Trials
Phase 4 168
Phase 3 190
Phase 2/Phase 3 31
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Clinical Trial Status

Clinical Trial Status for Zinc Sulfate
Clinical Trial Phase Trials
Completed 504
Recruiting 129
Unknown status 111
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Clinical Trial Sponsors for Zinc Sulfate

Sponsor Name

Sponsor Name for Zinc Sulfate
Sponsor Trials
National Cancer Institute (NCI) 160
Assiut University 30
AstraZeneca 21
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Sponsor Type

Sponsor Type for Zinc Sulfate
Sponsor Trials
Other 907
Industry 369
NIH 202
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