CLINICAL TRIALS PROFILE FOR SINCALIDE

All Clinical Trials for sincalide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004414 ↗	Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis	Completed	University of Michigan	N/A	1997-09-01	OBJECTIVES: I. Compare conjugated bilirubin levels and serum bile acid levels in severely premature newborns on long term parenteral nutrition and given either sincalide or placebo. II. Compare morbidity and mortality rates in this patient population. III. Evaluate ultrasonographic images of the hepatobiliary tree during and 1 to 2 years after the administration of sincalide or placebo to assess the development of biliary sludge and biliary stone formation.
NCT00685477 ↗	Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying	Completed	Johns Hopkins University	N/A	2008-05-01	This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease.
NCT00685477 ↗	Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying	Completed	Memorial Health University Medical Center	N/A	2008-05-01	This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease.
NCT00685477 ↗	Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying	Completed	Penn State University	N/A	2008-05-01	This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease.
NCT00685477 ↗	Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying	Completed	Temple University	N/A	2008-05-01	This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease.
NCT00706381 ↗	Thyroid Hormones Homeostasis and Energy Metabolism Changes During Stimulation of Endogenously Secreted Bile Acids (BAs)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	2008-06-23	Postprandial thermogenesis, or thermic effect of food are terms that describe the increase in utilization of energy by the human body following a meal. The mechanisms involved in this process are believed to differ according to the type of food consumed, whether fat, protein or carbohydrate. The bile acids (BAs), unique substances secreted by the gall bladder into the gut after a meal, play an important role in the absorption of fat and the management of cholesterol stores in the body. Recent studies suggest that BAs may also serve as regulators of energy expenditure (consumption) in the cells of our body by increasing the production of T3, an active form of thyroid hormone. T3 in turn is believed to increase the efficiency with which our bodies burn calories thereby generating heat. Although this process has been shown to be effective in rodents who demonstrated weight loss after treatment, the role of BAs in humans is poorly understood. Thus we do not know whether endogenous (produced by the body) or exogenous (taken as medication) BAs play a significant role in the maintenance of body weight. We hypothesize that, similarly to rodents, humans will respond to BAs by increasing energy expenditure via the production of the active form of thyroid hormone. This randomized, cross-over study will look at changes in thyroid hormones and energy consumption in response to stimuli of endogenous BA secretion including dietary content, and to the intake of pharmacological doses of bile acids. Following a two-day period of equilibration diet, 30 healthy volunteers will be randomly assigned to receive either a high-fat or high-carbohydrate isocaloric meal followed by a 6-hour metabolic chamber stay; the next day they will be crossed-over to the alternate intervention. During the following three days, the study subjects will again be randomized to receive either an intravenous injection of sincalide (the C-terminal octapeptide fragment of cholecystokinin) 0.04 mcg/kg or placebo and P.O. placebo, or I.V. placebo and 15 mg/kg of BA (ursodiol) with similar metabolic chamber stays and cross-over design. The data gathered from this study will provide greater insight into the physiological and molecular mechanism(s) regulating the relation between endogenous bile acid secretion and energy metabolism in response to meals, as well as the role of BAs per se on energy metabolism.

Clinical Trial Conditions for sincalide

Condition Name

Condition Name for sincalide
Intervention	Trials
Healthy Volunteers	2
Cholestasis	1
Healthy	1

Condition MeSH

Condition MeSH for sincalide
Intervention	Trials
Thyroid Diseases	1
Cholestasis	1

Clinical Trial Locations for sincalide

Trials by Country

Trials by Country for sincalide
Location	Trials
United States	9

Trials by US State

Trials by US State for sincalide
Location	Trials
Maryland	2
Texas	1
Rhode Island	1
Ohio	1
New York	1

Clinical Trial Progress for sincalide

Clinical Trial Phase

Clinical Trial Phase for sincalide
Clinical Trial Phase	Trials
Phase 3	1
Phase 1	1
N/A	2

Clinical Trial Status

Clinical Trial Status for sincalide
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	1

Clinical Trial Sponsors for sincalide

Sponsor Name

Sponsor Name for sincalide
Sponsor	Trials
University of Michigan	1
Johns Hopkins University	1
Memorial Health University Medical Center	1

Sponsor Type

Sponsor Type for sincalide
Sponsor	Trials
Other	5
NIH	1
Industry	1