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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Single Group Assignment

Study Primary Completion Date: August 2007

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.

Intervention(s) in this Clinical Trial

• Behavioral: Observe patients with inactive ulcerative colitis
  • Observe patients with inactive ulcerative colitis

Primary Measures

• Change between rectal biopsies performed at D1 and D28 of proliferative index
  • Time Frame: Its aim was to study histological modifications after Pentasa was stopped in non-active ulcerative colitis.
    Safety Issue?: No

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-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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Ferring Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Jean-Pierre GENDRE, Professor Principal Investigator Hôpital Saint Antoine, Service d'hépato-Gastroentérologie  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00209287

Study ID Number: Mesalazine 2004-01

ClinicalTrials.gov Identifier: NCT00209287

Health Authority: France: Afssaps - French Health Products Safety Agency