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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00209287
• Other study ID #: Mesalazine 2004-01
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: April 20, 2012
• Start date: June 2005
• Est. completion date: September 2007

Study information

• Verified date: April 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Behavioral:
• Observe patients with inactive ulcerative colitis
Observe patients with inactive ulcerative colitis

Locations

Country	Name	City	State
France	Hôpital Saint Antoine, Service d'hépato-Gastroentérologie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change between rectal biopsies performed at D1 and D28 of proliferative index		Its aim was to study histological modifications after Pentasa was stopped in non-active ulcerative colitis.	No