Study of Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 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
Outcome Measures
Primary Outcome Measures
- Change between rectal biopsies performed at D1 and D28 of proliferative index [Its aim was to study histological modifications after Pentasa was stopped in non-active ulcerative colitis.]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Saint Antoine, Service d'hépato-Gastroentérologie | Paris | France |
Sponsors and Collaborators
- Ferring Pharmaceuticals
Investigators
- Study Director: Clinical Development Support, Ferring Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Mesalazine 2004-01