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Last Updated: July 5, 2020

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CLINICAL TRIALS PROFILE FOR VICKS FORMULA 44

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505(b)(2) Clinical Trials for Vicks Formula 44

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 NCT00125281 SAMe to Treat Biliary Cirrhosis Symptoms Terminated National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2005-07-01 This study will examine the effect of S-adenosyl methionine (SAMe) on itching and fatigue in patients with primary biliary cirrhosis, a disease of the small bile ducts in the liver. Ursodiol, the only currently available treatment for biliary cirrhosis, does not cure the disease, and many people continue to have symptoms or liver test abnormalities despite treatment. SAMe is a naturally occurring substance found in most cells of the body. The highest levels of the substance are produced by the liver, where it helps to rid the body of toxins and breakdown products of metabolism. Studies in Europe suggest that SAMe may help to: 1) decrease the fatigue and itching that are common in persons with liver problems, and 2) decrease levels of liver enzymes in the blood, suggesting that it may decrease the amount of liver injury. Patients 21 years of age or older with primary biliary cirrhosis who are taking ursodiol and have symptoms of itching or fatigue may be eligible for this study. Candidates are screened with a medical history, physical examination, review of medical records, routine blood tests, and a symptoms rating scale. Participants stop all medications for itching 4 weeks before starting the study, but continue to take ursodiol during the 42-week trial. On entering the study, patients are assigned to take either SAMe or placebo tablets twice a day for 12 weeks. While taking the medications, they are followed in the clinic every 2 weeks for the first month and then every 4 weeks to fill out symptoms questionnaires and have a short medical evaluation and blood tests. At the end of 12 weeks, treatment is interrupted for a 2-week "wash-out" period, after which patients begin a 12-week crossover treatment; that is, patients who were taking SAMe are switched to placebo, and those who were taking placebo are switched to SAMe. After completing the second 12-week treatment course, patients come to the clinic at 4, 8, and 12 weeks to fill out symptoms questionnaires and have a medical evaluation and blood tests. At the last visit, patients are told which type of tablet they received during the two courses of treatment. SAMe is available without prescription in many forms as an over-the-counter medication.
New Formulation NCT00490932 New Hypo-Osmolar ORS (Recommended by WHO) for Routine Use in the Diarrhea Management– Surveillance Study for Adverse Effects Completed Society for Applied Studies Phase 4 2005-03-01 For more than 25 years WHO and UNICEF have recommended a single formulation of glucose-based Oral Rehydration Salts (ORS) to prevent or treat dehydration from diarrhoea irrespective of the cause or age group affected. This product has proven effective and contributed substantially to the dramatic global reduction in mortality from diarrhoeal disease during the period. Based on more than two decades of research and recommendations by an expert group, WHO and UNICEF reviewed the effectiveness of a new ORS formula with reduced concentration of glucose and salts. Because of the improved effectiveness of this new ORS solution WHO and UNICEF recommended that countries use and manufacture this new formulation in place of the old one. While recommending this new ORS the experts also recommended that further monitoring is desirable to better assess the risk, if any of symptomatic hyponatraemia (low blood level of sodium salt). This is a surveillance study to evaluate adverse effect of routinely using the new ORS in a hospital admitting over 20,000 patients with diarrhea of all ages including cholera. If the new ORS is found safe, it will provide added confidence in its global use.
OTC NCT01451918 Regulation of Intestinal and Hepatic Lipoprotein Secretion by Resveratrol Completed Canadian Institutes of Health Research (CIHR) Phase 2 2011-10-01 Resveratrol, an ingredient of red wine and available in Canada in highly purified form as an over-the-counter health supplement, has been shown to have a number of health benefits. Data from in vitro and animal studies suggest that it has beneficial effects on insulin sensitivity and lipid lowering. The investigators are not aware, however, of any mechanistic studies that have examined the effect of highly purified resveratrol in vivo on lipoprotein metabolism in humans. Given the potential therapeutic benefit of resveratrol in correcting the metabolic abnormalities of insulin resistant individuals the investigators plan to examine the effects of resveratrol on intestinal and hepatic lipoprotein production in humans.
OTC NCT01451918 Regulation of Intestinal and Hepatic Lipoprotein Secretion by Resveratrol Completed University Health Network, Toronto Phase 2 2011-10-01 Resveratrol, an ingredient of red wine and available in Canada in highly purified form as an over-the-counter health supplement, has been shown to have a number of health benefits. Data from in vitro and animal studies suggest that it has beneficial effects on insulin sensitivity and lipid lowering. The investigators are not aware, however, of any mechanistic studies that have examined the effect of highly purified resveratrol in vivo on lipoprotein metabolism in humans. Given the potential therapeutic benefit of resveratrol in correcting the metabolic abnormalities of insulin resistant individuals the investigators plan to examine the effects of resveratrol on intestinal and hepatic lipoprotein production in humans.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Vicks Formula 44

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000574 Ibuprofen in Sepsis Study Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1990-09-01 To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
NCT00000574 Ibuprofen in Sepsis Study Completed Vanderbilt University Medical Center Phase 3 1990-09-01 To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
NCT00000873 A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) N/A 1969-12-31 This study examines the effects of an infant formula containing increased calories, as compared to commercial formulas, when given during the first 6 months of life. It will examine effects on growth, disease progress, immune system, and quality of life of infected infants. HIV disease in infants often leads to nutritional deficiencies. Providing increased nutrition early in their lives may help the quality of life of children who contract HIV from their mothers.
NCT00000873 A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 This study examines the effects of an infant formula containing increased calories, as compared to commercial formulas, when given during the first 6 months of life. It will examine effects on growth, disease progress, immune system, and quality of life of infected infants. HIV disease in infants often leads to nutritional deficiencies. Providing increased nutrition early in their lives may help the quality of life of children who contract HIV from their mothers.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Vicks Formula 44

Condition Name

Condition Name for Vicks Formula 44
Intervention Trials
HIV Infections 9
Healthy 8
Obesity 8
Anemia 6
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Condition MeSH

Condition MeSH for Vicks Formula 44
Intervention Trials
Syndrome 28
Kidney Diseases 20
Diabetes Mellitus 17
Renal Insufficiency 13
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Clinical Trial Locations for Vicks Formula 44

Trials by Country

Trials by Country for Vicks Formula 44
Location Trials
United States 441
China 110
Italy 26
Canada 25
Taiwan 24
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Trials by US State

Trials by US State for Vicks Formula 44
Location Trials
New York 26
California 26
Texas 25
Maryland 24
Florida 23
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Clinical Trial Progress for Vicks Formula 44

Clinical Trial Phase

Clinical Trial Phase for Vicks Formula 44
Clinical Trial Phase Trials
Phase 4 134
Phase 3 80
Phase 2/Phase 3 33
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Clinical Trial Status

Clinical Trial Status for Vicks Formula 44
Clinical Trial Phase Trials
Completed 259
Recruiting 135
Not yet recruiting 81
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Clinical Trial Sponsors for Vicks Formula 44

Sponsor Name

Sponsor Name for Vicks Formula 44
Sponsor Trials
Hoosier Cancer Research Network 17
National Institute of Allergy and Infectious Diseases (NIAID) 11
Shanghai University of Traditional Chinese Medicine 9
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Sponsor Type

Sponsor Type for Vicks Formula 44
Sponsor Trials
Other 832
Industry 164
NIH 54
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