Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113503
Status:
TERMINATED
Last Update Posted:
2017-10-06
First Post:
2005-06-08
Brief Title:
Imuran Dosing in Crohns Disease Study
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
A Multi-site Trial of Azathioprine Dosing in Crohns Disease
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare two different dosing methods of azathioprine IMURAN in participants with Crohns disease who are currently taking steroids eg prednisone or budesonideor who have just started steroids The study can be up to 54 weeks long All participants enrolled will receive active drug Participants will take doses either based upon weight or based on the patients ability to breakdown the drug monitored by 6-thioguanine nucleotides 6-TGN metabolite levels in the blood All patients enrolled in the study will receive active study drug
Detailed Description:
This multi-center double blind patients and doctors do not know treatment group assignment randomized patients are put in 1 of 2 groups clinical trial which will compare two 52-week-long azathioprineAZA dosing methods
The patients enrolled will all be taking steroids prednisone or budesonideor have just been prescribed a steroid The patients will be either in remission on steroids but cannot taper off without a flare patients who are on steroids and are still having Crohns symptoms or patients who need to start taking steroids
After a two week screening period patients fitting enrollment criteria will be begin taking study drug Patients will begin to taper steroids per a set schedule and taper off steroids completely by week 13 Patients who need to go back on steroids because of returned symptoms are allowed to per a set schedule in the protocol Patients will have monthly visits that include physical exams blood tests and a quality of life questionnaire Patients will be required to keep a diary of abdominal pain liquid or soft stools and general well being
After 6 months only patients in remission patients not on steroids and not having active symptoms will be allowed to continue for last 6 months of the study Study visits during the last 6 months will be every 2 months and include physical exams and blood tests and a quality of life questionnaire
Patients in the study may receive dose changes and this will require additional blood tests for safety
The patients enrolled will all be taking steroids prednisone or budesonideor have just been prescribed a steroid The patients will be either in remission on steroids but cannot taper off without a flare patients who are on steroids and are still having Crohns symptoms or patients who need to start taking steroids
After a two week screening period patients fitting enrollment criteria will be begin taking study drug Patients will begin to taper steroids per a set schedule and taper off steroids completely by week 13 Patients who need to go back on steroids because of returned symptoms are allowed to per a set schedule in the protocol Patients will have monthly visits that include physical exams blood tests and a quality of life questionnaire Patients will be required to keep a diary of abdominal pain liquid or soft stools and general well being
After 6 months only patients in remission patients not on steroids and not having active symptoms will be allowed to continue for last 6 months of the study Study visits during the last 6 months will be every 2 months and include physical exams and blood tests and a quality of life questionnaire
Patients in the study may receive dose changes and this will require additional blood tests for safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| U01DK060083 | NIH | None | httpsreporternihgovquickSearchU01DK060083 |