Study of Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treat… (NCT00209287) | Clinical Trial Compass
TerminatedPhase 4
Study of Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis
Stopped: Recruitment problematic
France6 participantsStarted 2005-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change between rectal biopsies performed at D1 and D28 of proliferative index
Timeframe: Its aim was to study histological modifications after Pentasa was stopped in non-active ulcerative colitis.