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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

Primary Purpose

Ulcerative Colitis

Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Observe patients with inactive ulcerative colitis
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis for Maintenance of Remission

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hôpital Saint Antoine, Service d'hépato-Gastroentérologie

Outcomes

Primary Outcome Measures

Change between rectal biopsies performed at D1 and D28 of proliferative index

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
April 20, 2012
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00209287
Brief Title
Study of Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis
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 Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Why Stopped
Recruitment problematic
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis for Maintenance of Remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Observe patients with inactive ulcerative colitis
Intervention Description
Observe patients with inactive ulcerative colitis
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Saint Antoine, Service d'hépato-Gastroentérologie
City
Paris
Country
France

12. IPD Sharing Statement

Learn more about this trial

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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