A Phase 3 interventional study of Budesonide in Microscopic Colitis, sponsored by Technische Universität Dresden. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-03-30.
Sponsored by Technische Universität Dresden · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis
The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis
23 studies on the registry are indexed under Colitis, Microscopic; 6 are open to participants now.
This study's planned enrollment of 40 is below the median of 47 across 14 interventional studies indexed under Colitis, Microscopic.
Browse Colitis, Microscopic studies →Technische Universität Dresden is the lead sponsor of 247 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Proportion of patients in clinical remission after 6 weeks
safety
quality of life
histological improvement
The record gives a start of Jan 2002, a primary completion of Aug 2006 and a completion of Aug 2007. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Budesonide
Technische Universität Dresden →