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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

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ClinicalTrials.gov Identifier: NCT00209287
Recruitment Status : Terminated (Recruitment problematic)
First Posted : September 21, 2005
Last Update Posted : April 23, 2012
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Behavioral: Observe patients with inactive ulcerative colitis Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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
Study Start Date : June 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Behavioral: Observe patients with inactive ulcerative colitis
    Observe patients with inactive ulcerative colitis


Primary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00209287     History of Changes
Other Study ID Numbers: Mesalazine 2004-01
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: April 23, 2012
Last Verified: April 2012

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

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