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

This study has been terminated.
(Recruitment problematic)
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00209287
First received: September 13, 2005
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
 Behavioral: Observe patients with inactive ulcerative colitis
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Change between rectal biopsies performed at D1 and D28 of proliferative index [ Time Frame: Its aim was to study histological modifications after Pentasa was stopped in non-active ulcerative colitis. ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: June 2005
Study Completion Date: September 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Observe patients with inactive ulcerative colitis
    Observe patients with inactive ulcerative colitis
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209287

Locations
France
Hôpital Saint Antoine, Service d'hépato-Gastroentérologie
Paris, France
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00209287     History of Changes
Other Study ID Numbers: Mesalazine 2004-01
Study First Received: September 13, 2005
Last Updated: April 20, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Ferring Pharmaceuticals:
Ulcerative Colitis for Maintenance of Remission

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013