Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209287
Status:
TERMINATED
Last Update Posted:
2012-04-23
First Post:
2005-09-13
Brief Title:
Study of Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis
Sponsor:
Ferring Pharmaceuticals
Organization:
Ferring Pharmaceuticals
Study Overview
Official Title:
Study of Histological Modifications of Pro-apoptotic Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis Clinical and Endoscopic Remission Taking 5-ASA
Status:
TERMINATED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment problematic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Male or female 18 years of age or older Ulcerative Colitis described according usual criteria diagnosed for at least 1 year Oral maintenance treatment with 5-aminosalicylic acid 5-ASA only for at least 3 months with a dosage of 2 to 3 gday Clinical remission for at least 3 months Mayo Clinic score and endoscopic remission endoscopic score of Mayo Clinic at the inclusion Signed informed consent form
Detailed Description:
Inclusion Criteria
Male or female 18 years of age or older
Ulcerative colitis described according to usual criteria diagnosed for at least 1 year
Oral maintenance treatment with 5-aminosalicylic acid 5-ASA only for at least 3 months with a dosage of 2 to 3 gday
Clinical remission for at least 3 months Mayo Clinic score and endoscopic remission endoscopic score of Mayo Clinic at inclusion
Signed informed consent form
Exclusion Criteria
Patients allergic to aspirin or salicylates derivatives
Patients taking the following treatments during the study will be excluded corticosteroids oral or rectal route use of NSAID or Aspirin any form of sulfasalazine mesalazine or 4-ASA
Patients with known significant hepatic or known function abnormalities andor creatine clearance 80 mlmin
Patients with history or physical examination findings indicative of active alcohol or drug abuse
Women who are pregnant or nursing
Patients with a history of disease including mentalemotional disorder that would interfere with their participation in the study
Patients who participated in another clinical study in the last 3 months
Patients who are unable to comply with the requirements of the protocol
Female of childbearing potential without efficacious contraception
Male or female 18 years of age or older
Ulcerative colitis described according to usual criteria diagnosed for at least 1 year
Oral maintenance treatment with 5-aminosalicylic acid 5-ASA only for at least 3 months with a dosage of 2 to 3 gday
Clinical remission for at least 3 months Mayo Clinic score and endoscopic remission endoscopic score of Mayo Clinic at inclusion
Signed informed consent form
Exclusion Criteria
Patients allergic to aspirin or salicylates derivatives
Patients taking the following treatments during the study will be excluded corticosteroids oral or rectal route use of NSAID or Aspirin any form of sulfasalazine mesalazine or 4-ASA
Patients with known significant hepatic or known function abnormalities andor creatine clearance 80 mlmin
Patients with history or physical examination findings indicative of active alcohol or drug abuse
Women who are pregnant or nursing
Patients with a history of disease including mentalemotional disorder that would interfere with their participation in the study
Patients who participated in another clinical study in the last 3 months
Patients who are unable to comply with the requirements of the protocol
Female of childbearing potential without efficacious contraception
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