Study of Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis
NCT ID: NCT00209287
Last Updated: 2012-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE4
6 participants
INTERVENTIONAL
2005-06-30
2007-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA
NCT05992142
A Single-Center Observational Study on the Impact of Symptom Assessment Timing on the Short-Term Efficacy of 5-ASA Therapy in Patients With Initial-Onset or Relapsed Mild-to-Moderate Active Ulcerative Colitis
NCT06998693
Observational Study in the Management of Ulcerative Colitis With Oral 5-ASA
NCT01654783
Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis
NCT05213234
Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis
NCT01941589
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Observe patients with inactive ulcerative colitis
Observe patients with inactive ulcerative colitis
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ferring Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Saint Antoine, Service d'hépato-Gastroentérologie
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Mesalazine 2004-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.