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

Sponsored by:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00209287

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 IV

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Endoscopy Ulcerative Colitis

Drug Information available for: Mesalamine Proline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Single Group Assignment
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

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 ]

Estimated Enrollment:	20
Study Start Date:	June 2005
Estimated Study Completion Date:	September 2007
Estimated Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Intervention Details:

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, Paris
Hôpital Saint Antoine, Service d'hépato-Gastroentérologie	Recruiting
184 rue Faubourg Saint Antoine, Paris, France, 75012
Contact: Jean-Pierre GENDRE, MD 33149283172 Jean-Pierre.gendre@sat.ap-hop-paris.fr

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Principal Investigator:

Jean-Pierre GENDRE, Professor

Hôpital Saint Antoine, Service d'hépato-Gastroentérologie

More Information

Responsible Party:	Hospital Saint Antoine, Service d'hepato-Gastroenterologie ( Jean-Pierre GENDRE, Professor )
Study ID Numbers:	Mesalazine 2004-01
Study First Received:	September 13, 2005
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00209287
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Ferring Pharmaceuticals:

Ulcerative Colitis for Maintenance of Remission

Study placed in the following topic categories:

Digestive System Diseases
Mesalamine
Gastrointestinal Diseases
Ulcer
Colonic Diseases

Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009