Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287170
Status:
COMPLETED
Last Update Posted:
2008-07-08
First Post:
2006-02-02
Brief Title:
Efficacy Study of Targeted Local Delivery of Drugs to Treat Crohns Disease
Sponsor:
Teva GTC
Organization:
Teva GTC
Study Overview
Official Title:
Pilot Open-Label Randomized Parallel Group Study to Evaluate Clinical and Immunological EfficacySafety of Locally Delivered 6-MP or Calcitriol vs Purinethol in Non-Steroid Dependent Patients With Active CD
Status:
COMPLETED
Status Verified Date:
2008-07
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:
The study is being undertaken to evaluate whether delayed-release medications designed to begin to open in the lower intestinal tract the main site of Crohns Disease are more effective than standard systemically delivered drugs to promote remission or response in CD patients It is hypothesized that the delayed-release medications will go right to the injured tissue and heal the disease more quickly
The delayed-release test drugs are 6-mercaptopurine at a dose of 40 mg daily or calcitriol at a dose of 5 mcg three times a week versus Purinethol 6-MP at a dose of 1-2 mgkg body weight daily Calcitriol is a synthetically manufactured replica of a natural substance in the body that is derived from Vitamin D There is much medical evidence that shows that lack of Vitamin D can be a possible risk factor in developing autoimmune disorders including Crohns Disease Moreover calcitriol has been shown in animal models to improve the symptoms of Crohns Disease
The delayed-release test drugs are 6-mercaptopurine at a dose of 40 mg daily or calcitriol at a dose of 5 mcg three times a week versus Purinethol 6-MP at a dose of 1-2 mgkg body weight daily Calcitriol is a synthetically manufactured replica of a natural substance in the body that is derived from Vitamin D There is much medical evidence that shows that lack of Vitamin D can be a possible risk factor in developing autoimmune disorders including Crohns Disease Moreover calcitriol has been shown in animal models to improve the symptoms of Crohns Disease
Detailed Description:
This pilot clinical study is designed to evaluate the efficacy and safety of oral administration of novel delayed-release test formulations for targeted delivery to the ileum in Crohns Disease patients The local delivery drugs delayed-release formulations of 6-mercaptopurine or calcitriol will be compared to standard Purinethol treatment after 12 weeks of treatment to evaluate
1 local intestinal mucosal inflammation and damage as shown by markers of biopsy tissue CDEIS and pathologist review of biopsies
2 Clinical symptoms of active Crohns Disease CDAI scores- remission 150 response- a drop of 100 points from baseline IBDQ scores- 180 indicative of remission and
3Systemic improvement as shown by blood immunological and inflammatory markers CRP and ESR
It is hypothesized that since CD is a localized autoimmune inflammation of the intestinal mucosa a far more effective and potentially safer treatment would be targeted local delivery of effective drugs directly to the disease site The drug would be concentrated in the specific area of disease while unwanted systemic side effects would be minimized The drugs selected for evaluation are 6-MP a mainstay of CD treatment for over 30 years and calcitriol a synthetically manufactured Vitamin D derivative which is being evaluated in many studies for its impressive immunomodulatory effects in cancer MS and other autoimmune disorders
1 local intestinal mucosal inflammation and damage as shown by markers of biopsy tissue CDEIS and pathologist review of biopsies
2 Clinical symptoms of active Crohns Disease CDAI scores- remission 150 response- a drop of 100 points from baseline IBDQ scores- 180 indicative of remission and
3Systemic improvement as shown by blood immunological and inflammatory markers CRP and ESR
It is hypothesized that since CD is a localized autoimmune inflammation of the intestinal mucosa a far more effective and potentially safer treatment would be targeted local delivery of effective drugs directly to the disease site The drug would be concentrated in the specific area of disease while unwanted systemic side effects would be minimized The drugs selected for evaluation are 6-MP a mainstay of CD treatment for over 30 years and calcitriol a synthetically manufactured Vitamin D derivative which is being evaluated in many studies for its impressive immunomodulatory effects in cancer MS and other autoimmune disorders
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