Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125281
Status:
TERMINATED
Last Update Posted:
2017-07-02
First Post:
2005-07-29
Brief Title:
SAMe to Treat Biliary Cirrhosis Symptoms
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
S-Adenosyl Methionine for Symptomatic Treatment of Primary Biliary Cirrhosis
Status:
TERMINATED
Status Verified Date:
2008-07-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
To assess the efficacy of S-adenosyl methionine SAMe in symptomatic relief of primary biliary cirrhosis PBC we will treat up to 50 patients with either SAM-e 800 mg BID or placebo for 12 weeks in a cross-over double-blind placebo-controlled study
S-adenosyl methionine is a nutritional supplement which is available as an over-the-counter formula and is used for treatment of depression and arthritic pain SAMe is produced in virtually all cells and participates in many biochemical pathways as a major methyl contributor Intracellular levels of SAMe are often decreased in advanced liver disease At present SAMe is undergoing extensive evaluation in a large multicenter randomized controlled trial as an adjunctive therapy of alcoholic liver disease SAMe has also been evaluated in patients with intrahepatic cholestasis and cholestasis of pregnancy with promising effects of relieving pruritus and fatigue and improving serum liver associated enzymes
In this study we will recruit patients with PBC who have pruritus or fatigue despite therapy with ursodiol the currently recommended therapy of PBC which is partially effective in relieving pruritus and fatigue After medical evaluation and a brief period of monitoring patients will be randomized to receive either SAMe or placebo given in oral form in similar appearing capsules twice daily Patients will be followed at regular intervals for symptoms as monitored by validated questionnaires as well as for side effects and serum biochemical and hematological tests After 12 weeks therapy will be withdrawn for 2 weeks and patients will then be switched to the alternative capsules either SAMe or placebo for another 12 weeks The primary endpoints of therapy will be improvements in symptoms of pruritus or fatigue or both Secondary endpoints will be improvements in serum biochemical liver related enzymes
S-adenosyl methionine is a nutritional supplement which is available as an over-the-counter formula and is used for treatment of depression and arthritic pain SAMe is produced in virtually all cells and participates in many biochemical pathways as a major methyl contributor Intracellular levels of SAMe are often decreased in advanced liver disease At present SAMe is undergoing extensive evaluation in a large multicenter randomized controlled trial as an adjunctive therapy of alcoholic liver disease SAMe has also been evaluated in patients with intrahepatic cholestasis and cholestasis of pregnancy with promising effects of relieving pruritus and fatigue and improving serum liver associated enzymes
In this study we will recruit patients with PBC who have pruritus or fatigue despite therapy with ursodiol the currently recommended therapy of PBC which is partially effective in relieving pruritus and fatigue After medical evaluation and a brief period of monitoring patients will be randomized to receive either SAMe or placebo given in oral form in similar appearing capsules twice daily Patients will be followed at regular intervals for symptoms as monitored by validated questionnaires as well as for side effects and serum biochemical and hematological tests After 12 weeks therapy will be withdrawn for 2 weeks and patients will then be switched to the alternative capsules either SAMe or placebo for another 12 weeks The primary endpoints of therapy will be improvements in symptoms of pruritus or fatigue or both Secondary endpoints will be improvements in serum biochemical liver related enzymes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-DK-0207 | None | None | None |