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

September 13, 2005
April 20, 2012
June 2005
December 2006   (final data collection date for primary outcome measure)
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 ]
To demonstrate that the foam enema (mesalazine foam) 1g/100ml mesalazine per day is at least as effective as the reference liquid enema mesalazine 1g/100ml per day, in patients with left-sided active ulcerative colitis treated for 28 days
Complete list of historical versions of study NCT00209287 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Study of Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis
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.

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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Ulcerative Colitis
Behavioral: Observe patients with inactive ulcerative colitis
Observe patients with inactive ulcerative colitis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
September 2007
December 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00209287
Mesalazine 2004-01
No
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP