CLINICAL TRIALS PROFILE FOR COSYNTROPIN

All Clinical Trials for COSYNTROPIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006270 ↗	Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury	Unknown status	University of Texas		1998-02-01	OBJECTIVES: I. Determine the randomness of adrenocorticotropic hormone (ACTH) and cortisol secretion using approximate entropy in patients who have sustained a head injury. II. Determine the correlation between randomness of ACTH and cortisol secretion and stages of sleep in these patients.
NCT00006270 ↗	Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury	Unknown status	National Center for Research Resources (NCRR)		1998-02-01	OBJECTIVES: I. Determine the randomness of adrenocorticotropic hormone (ACTH) and cortisol secretion using approximate entropy in patients who have sustained a head injury. II. Determine the correlation between randomness of ACTH and cortisol secretion and stages of sleep in these patients.
NCT00391170 ↗	Dexamethasone to Prevent Oral Chronic Graft-versus-Host Disease	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	2006-11-24	This study will determine if a dexamethasone mouth rinse can reduce the risk of developing oral chronic graft-versus-host disease (cGVHD) in patients who have undergone a bone marrow (stem cell) transplant procedure. cGVHD is a common complication of stem cell transplantation, resulting from the donor cells attacking the transplant recipient's tissues. In oral cGVHD, the tissues in the mouth are damaged, causing painful mouth sores. Dexamethasone is a corticosteroid that is commonly used to treat inflammation. It is the only corticosteroid available that can be used as a mouth rinse. Patients 12 years of age or older who have received a stem cell transplant may be eligible to participate if they are enrolled within 70 to 90 days of their transplant. Candidates are screened with a medical history and oral exam. Participants are randomly assigned to receive either the dexamethasone rinse or a placebo (a solution that looks and tastes like the dexamethasone rinse but has no active medication). They undergo the following procedures: Treatment with the study solution. Patients rinse their mouth with the dexamethasone solution or placebo three times a day for 3 months. Clinic visits before starting treatment and at 1, 2 and 3 months after starting the study drug for the following procedures: - Oral exam (before starting treatment and at each visit). - Photographs of the mouth (before starting treatment and at 3 months). - Biopsy from inside the cheek (before starting treatment). The inside of the cheek is numbed and a small piece of tissue is removed for examination by a pathologist. - Saliva sample collection (before starting treatment). - Blood draw (before starting treatment and at each visit). - Quality-of-life questionnaires (before starting treatment and at 3 months). - Questionnaire to assess level of dry mouth and mouth pain (before starting treatment and at each visit). - Review of medications (at each visit). - ACTH stimulation test to evaluate adrenal gland function (at 3 months). Patients are given an injection of a drug called "ACTH" or "cosynthropin," which is a version of a hormone normally produced by the pituitary gland. Blood samples are drawn before the injection and at 30 and 60 minutes after the injection to measure levels of the hormone cortisol. After treatment ends, participants are contacted by telephone every month for 6 months to report any symptoms of cGVHD, and they return to the clinic at 6 months for a final evaluation.
NCT00805285 ↗	The Use of Oral Budesonide and Rectal Hydrocortisone for the Treatment of Active Ulcerative Colitis	Terminated	University of Maryland	Phase 2	2008-10-01	The purpose of this study is to evaluate if the combination of oral budesonide and rectal hydrocortisone improves symptoms in patients with active ulcerative colitis. Also, we would like to determine if oral budesonide and rectal hydrocortisone has fewer and less severe side effects compared to standard steroids (prednisone).
NCT00805285 ↗	The Use of Oral Budesonide and Rectal Hydrocortisone for the Treatment of Active Ulcerative Colitis	Terminated	University of Maryland, Baltimore	Phase 2	2008-10-01	The purpose of this study is to evaluate if the combination of oral budesonide and rectal hydrocortisone improves symptoms in patients with active ulcerative colitis. Also, we would like to determine if oral budesonide and rectal hydrocortisone has fewer and less severe side effects compared to standard steroids (prednisone).

Clinical Trial Conditions for COSYNTROPIN

Condition Name

Condition Name for COSYNTROPIN
Intervention	Trials
Polycystic Ovary Syndrome	3
Adrenal Insufficiency	3
Stress, Physiological	1
Adrenal Suppression	1

Condition MeSH

Condition MeSH for COSYNTROPIN
Intervention	Trials
Polycystic Ovary Syndrome	3
Adrenal Insufficiency	3
Wounds and Injuries	2
Asthma	1

Clinical Trial Locations for COSYNTROPIN

Trials by Country

Trials by Country for COSYNTROPIN
Location	Trials
United States	47
Mexico	3
Bulgaria	1
Serbia	1
Italy	1

Trials by US State

Trials by US State for COSYNTROPIN
Location	Trials
Virginia	5
California	4
Texas	4
Florida	3
Illinois	3

Clinical Trial Progress for COSYNTROPIN

Clinical Trial Phase

Clinical Trial Phase for COSYNTROPIN
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	4
Phase 2	5

Clinical Trial Status

Clinical Trial Status for COSYNTROPIN
Clinical Trial Phase	Trials
Completed	13
Terminated	4
Recruiting	2

Clinical Trial Sponsors for COSYNTROPIN

Sponsor Name

Sponsor Name for COSYNTROPIN
Sponsor	Trials
University of Virginia	3
University of California, San Diego	2
INC Research	1

Sponsor Type

Sponsor Type for COSYNTROPIN
Sponsor	Trials
Other	25
Industry	7
NIH	4