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

NCT00209287 | Terminated Phase 4

• 1 other identifier: Mesalazine 2004-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis for Maintenance of Remission

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Observe patients with inactive ulcerative colitis BEHAVIORAL

Observe patients with inactive ulcerative colitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Signed informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Hôpital Saint Antoine, Service d'hépato-Gastroentérologie

Paris, France

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: June 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: September 1, 2007
• Last Updated: April 23, 2012

Record last verified: 2012-04

Locations

FR (1)