Status:
TERMINATED
Study of Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 a...
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-aminosal...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00209287
Start Date
June 1 2005
End Date
September 1 2007
Last Update
April 23 2012
Active Locations (1)
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1
Hôpital Saint Antoine, Service d'hépato-Gastroentérologie
Paris, France