Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098111
Status:
TERMINATED
Last Update Posted:
2014-02-21
First Post:
2004-12-03
Brief Title:
Imuran Azathioprine Dose-Ranging Study in Crohns Disease
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Double-Blinded Randomized Parallel Arm Dose Ranging Study of IMURAN in Subjects With Active Crohns Disease Requiring Treatment With Prednisone A Crohns Disease Optimal Range Dose of IMURAN Study ACORDIS
Status:
TERMINATED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to identify an optimal weight based dose of azathioprine that is safe and effective in the treatment of subjects with active Crohns disease requiring treatment with corticosteroids and for maintaining remission in those subjects
Detailed Description:
DESCRIPTION Medical therapy for Crohns disease is of variable success in ameliorating the cardinal symptoms of the disease diarrhea abdominal pain in treating extraintestinal manifestations fatigue anorexia fever weight loss arthralgias skin eye liver and kidney manifestations and in preventing complications stricture fistula abscess Currently therapy is most often implemented in a stepwise fashion progressing through anti-inflammatory medications sulfasalazine mesalamine antibiotics metronidazole ciprofloxacin corticosteroids immunomodulatory or immunosuppressive medications including thioguanine compounds 6 mercaptopurine or its prodrug azathioprine methotrexate and finally infliximab anti-tumor necrosis factor A common approach is the gradual addition of more potent medications to agents that are believed to be safer but may also be less effective Despite the current approach to medical therapy in Crohns disease a substantial number of patients-from 20 to 40-require surgery within 3 years of diagnosis excluding those requiring surgery at the time of diagnosis Nearly 80 of patients require surgery by 20 years from the onset of disease
Corticosteroids have long been a mainstay of therapy in Crohns disease although side effects are frequently observed with both short term and long-term use Potential side effects are well-described and may include relatively minor problems such as insomnia and acne as well as more serious adverse effects including hypertension narrow-angle glaucoma depression weight gain adrenal suppression Cushings syndrome diminished bone mineral density and infections
Azathioprine is often used to treat patients with steroid resistant or dependent Crohns disease Azathioprine is used as a steroid sparing agent as treatment for active inflammatory disease for maintenance of remission as therapy for perforating disease fistulae and for specific extraintestinal manifestations To date however randomized controlled clinical studies assessing a range of doses of azathioprine in Crohns disease have not been conducted The optimal weight-based dose is not known
EXPECTED CONTRIBUTION This study will identify an optimal weight based dose of azathioprine for treatment of patients with active Crohns disease requiring treatment with corticosteroids
STUDY HYPOTHESIS An optimal weight-based dose of azathioprine will induce and maintain remission in subjects with steroid-dependent Crohns disease
COMPARISON Three different doses of azathioprine will be compared in this study 05 25 and 35mgkgday Subjects will take the study medication for 9 months
Corticosteroids have long been a mainstay of therapy in Crohns disease although side effects are frequently observed with both short term and long-term use Potential side effects are well-described and may include relatively minor problems such as insomnia and acne as well as more serious adverse effects including hypertension narrow-angle glaucoma depression weight gain adrenal suppression Cushings syndrome diminished bone mineral density and infections
Azathioprine is often used to treat patients with steroid resistant or dependent Crohns disease Azathioprine is used as a steroid sparing agent as treatment for active inflammatory disease for maintenance of remission as therapy for perforating disease fistulae and for specific extraintestinal manifestations To date however randomized controlled clinical studies assessing a range of doses of azathioprine in Crohns disease have not been conducted The optimal weight-based dose is not known
EXPECTED CONTRIBUTION This study will identify an optimal weight based dose of azathioprine for treatment of patients with active Crohns disease requiring treatment with corticosteroids
STUDY HYPOTHESIS An optimal weight-based dose of azathioprine will induce and maintain remission in subjects with steroid-dependent Crohns disease
COMPARISON Three different doses of azathioprine will be compared in this study 05 25 and 35mgkgday Subjects will take the study medication for 9 months
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 |
|---|---|---|---|
| Grant 2555 | None | None | None |