Study of Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis
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|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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|