Study of Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis

Ferring

Status and phase

Terminated

Phase 4

Conditions

Ulcerative Colitis

Treatments

Behavioral: Observe patients with inactive ulcerative colitis

Study type

Interventional

Funder types

Industry

Identifiers

NCT00209287

Mesalazine 2004-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.