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

April 20, 2012 updated by: Ferring Pharmaceuticals

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

6

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Hôpital Saint Antoine, Service d'hépato-Gastroentérologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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-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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Its aim was to study histological modifications after Pentasa was stopped in non-active ulcerative colitis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

April 23, 2012

Last Update Submitted That Met QC Criteria

April 20, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mesalazine 2004-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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