CLINICAL TRIALS PROFILE FOR COSYNTROPIN
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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). |
| NCT00936793 ↗ | Drug Interaction Study Between Inhaled Beclomethasone and Protease Inhibitors in Healthy Volunteers | Completed | National Institutes of Health Clinical Center (CC) | Phase 1 | 2009-07-06 | Patients with human immunodeficiency virus (HIV) and respiratory disease commonly require protease inhibitors (PIs) and orally inhaled corticosteroids. Inhaled corticosteroids alone do not generally cause systemic adverse effects because of low systemic bioavailability, but the combination of inhaled fluticasone and various PIs has led to increased systemic fluticasone levels and multiple cases of secondary adrenal insufficiency. A study in healthy volunteers showed > 350-fold increase in fluticasone area under the curve when ritonavir (RTV) 100mg twice daily was coadministered with intranasal fluticasone compared to intranasal fluticasone alone. The mechanism of this drug interaction is presumably secondary to PI inhibition of cytochrome P450 3A4, the enzyme responsible for fluticasone metabolism. As a result, inhaled fluticasone is not recommended in combination with most PIs unless the benefit outweighs the risk. One possible alternative to fluticasone is inhaled beclomethasone, which has not been studied in combination with PIs. Although beclomethasone also undergoes metabolism via CYP3A4 in vitro to its more active metabolite, beclomethasone-17-monopropionate, it appears to be largely hydrolyzed by esterases in vivo. Furthermore, the pharmacokinetic properties of beclomethasone-17-monopropionate, such as relatively short half-life, low maximum plasma concentration, and low volume of distribution, suggest that systemic accumulation leading to significant adverse effects is unlikely even in the presence of a CYP3A4 inhibitor such as a PI. In this open-label study, 46 subjects will receive inhaled beclomethasone for 6 weeks from Days 1 to 42. Subjects will be randomized into 1 of 3 groups, such that from Days 15 to 42, 18 subjects will add no additional study drugs, 14 subjects will add RTV 100mg twice daily, and 14 subjects will add DRV/r 600/100mg twice daily. Pharmacokinetic sampling for beclomethasone and beclomethasone-17-monopropionate levels will occur on Days 14 and 28. Pre-cosyntropin cortisol levels and a low-dose adrenocorticotropic hormone (ACTH) stimulation test will be performed on all subjects on Days 1, 14, 28, and 42. Data from this investigation will determine whether RTV and/or DRV/r, potent CYP 3A4 inhibitors, alter the pharmacokinetics of beclomethasone and its active metabolite, beclomethasone-17-monopropionate (primary objective), and whether or not a possible increase in systemic bioavailability of beclomethasone and beclomethasone-17-monopropionate alters pre-cosyntropin cortisol levels and responses to ACTH stimulation test over a 4-week period (secondary objective). Results from this investigation will provide pharmacokinetic and pharmacodynamic data to assist clinicians in determining whether inhaled beclomethasone is an appropriate option in HIV-infected patients requiring concomitant therapy with an inhaled corticosteroid and PIs. |
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