CLINICAL TRIALS PROFILE FOR ZINC SULFATE
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505(b)(2) Clinical Trials for Zinc Sulfate
| 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. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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