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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 9, 2005 | ||||||||
| Last Updated Date | February 12, 2007 | ||||||||
| Start Date ICMJE | January 2002 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Proportion of patients in clinical remission after 6 weeks | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00180050 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Budesonide Treatment for Lymphocytic Colitis | ||||||||
| Official Title ICMJE | Efficacy and Safety of Budesonide for Treatment of Lymphocytic Colitis | ||||||||
| Brief Summary | The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis |
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| Detailed Description | The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis |
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| Study Phase | Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Microscopic Colitis | ||||||||
| Intervention ICMJE | Drug: Budesonide | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 40 | ||||||||
| Completion Date | August 2005 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00180050 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | BLYCK | ||||||||
| Study Sponsor ICMJE | Dresden University of Technology | ||||||||
| Collaborators ICMJE | Dr. Falk Pharma GmbH | ||||||||
| Investigators ICMJE |
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| Information Provided By | Dresden University of Technology | ||||||||
| Verification Date | July 2005 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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