Study of Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis

Ulcerative Colitis Clinical Trial

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

Clinical Trial 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 g/day. 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.

Clinical Trial 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 g/day.

• 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 and/or creatine clearance ≤ 80 ml/min.

• 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 mental/emotional 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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

• NCT number: NCT00209287
• Study type: Interventional
• Source: Ferring Pharmaceuticals
• Status: Terminated
• Phase: Phase 4
• Start date: June 2005
• Completion date: September 2007