Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167882
Status:
COMPLETED
Last Update Posted:
2006-09-11
First Post:
2005-09-09
Brief Title:
The Influence of 5-Aminosalicylates on Thiopurine Metabolite Levels
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-08
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 purpose of this study is to determine the influence of different 5-aminosalicylate concentrations on the metabolism of azathioprine or 6-mercaptopurine in patients with inflammatory bowel disease
Detailed Description:
Background
The concomitant use of 5-aminosalicylates 5ASA next to azathioprine AZA or 6-mercaptopurine 6MP in the treatment of inflammatory bowel disease IBD may lead to an increased effectiveness of therapy as higher levels of the active metabolite of AZA6MP 6-thioguaninenucleotides 6TGNs are measured
Objectives
To determine the influence of 5-ASA compounds and its metabolites on the metabolites of AZA6MP 6TGNs 6-methylmercaptopurine 6MMP
Methods
Patients with quiescent disease under AZA6MP therapy are eligible Patients will receive three succeeding regimes 5ASA 2 gram5ASA 4 gram no 5ASA of 4 weeks next to the standard AZA6MP therapy At the start and at the end of every regime 5ASA and its major metabolite N-acetyl-5ASA will be determined in serum next to the measurement of 6TGNs and 6MMP in erythrocytes The safety will monitored by standard laboratory parameters every four weeks
Population
Patients with IBD in remission and unchanged AZA6MP dosages for at least 4 weeks
Medication
5ASA Pentasa granules Ferring will be administered orally in dosages of 2 or 4 grams daily for a period of 4 weeks
Endpoints
The rise or decrease in 6TGNs and 6MMP during the different 5ASA regimes The evaluation of the safety of co-administrating 5ASA next to AZA6MP
Risks
Side effects of 5ASA use are limited and well known Some case reports have described the potential risk of developing a myelodepression when AZA6MP and 5ASA are given together due to the rise in 6TGNs However in daily practice both drugs are administered together frequently The risks of the frequent blood draws are minimal and usually self-limiting haematoma
The concomitant use of 5-aminosalicylates 5ASA next to azathioprine AZA or 6-mercaptopurine 6MP in the treatment of inflammatory bowel disease IBD may lead to an increased effectiveness of therapy as higher levels of the active metabolite of AZA6MP 6-thioguaninenucleotides 6TGNs are measured
Objectives
To determine the influence of 5-ASA compounds and its metabolites on the metabolites of AZA6MP 6TGNs 6-methylmercaptopurine 6MMP
Methods
Patients with quiescent disease under AZA6MP therapy are eligible Patients will receive three succeeding regimes 5ASA 2 gram5ASA 4 gram no 5ASA of 4 weeks next to the standard AZA6MP therapy At the start and at the end of every regime 5ASA and its major metabolite N-acetyl-5ASA will be determined in serum next to the measurement of 6TGNs and 6MMP in erythrocytes The safety will monitored by standard laboratory parameters every four weeks
Population
Patients with IBD in remission and unchanged AZA6MP dosages for at least 4 weeks
Medication
5ASA Pentasa granules Ferring will be administered orally in dosages of 2 or 4 grams daily for a period of 4 weeks
Endpoints
The rise or decrease in 6TGNs and 6MMP during the different 5ASA regimes The evaluation of the safety of co-administrating 5ASA next to AZA6MP
Risks
Side effects of 5ASA use are limited and well known Some case reports have described the potential risk of developing a myelodepression when AZA6MP and 5ASA are given together due to the rise in 6TGNs However in daily practice both drugs are administered together frequently The risks of the frequent blood draws are minimal and usually self-limiting haematoma
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