Study of Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis
|ClinicalTrials.gov Identifier: NCT00209287|
Recruitment Status : Terminated (Recruitment problematic)
First Posted : September 21, 2005
Last Update Posted : April 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Behavioral: Observe patients with inactive ulcerative colitis||Phase 4|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||September 2007|
Behavioral: Observe patients with inactive ulcerative colitis
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209287
|Hôpital Saint Antoine, Service d'hépato-Gastroentérologie|
|Study Director:||Clinical Development Support||Ferring Pharmaceuticals|