Clinical trial NCT00209287: Study of Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis for Maintenance of Remission
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change between rectal biopsies performed at D1 and D28 of proliferative index
timeFrame: Its aim was to study histological modifications after Pentasa was stopped in non-active ulcerative colitis.
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint Antoine, Service d'hépato-Gastroentérologie
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: