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| Tracking Information | |||||
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| First Received Date ICMJE | November 13, 2003 | ||||
| Last Updated Date | July 17, 2009 | ||||
| Start Date ICMJE | September 2000 | ||||
| Primary Completion Date | September 2003 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
patients who at the end of 6 weeks were classified as a success [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00073021 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis | ||||
| Official Title ICMJE | Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis | ||||
| Brief Summary | This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Ulcerative Colitis | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| 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 | Completed | ||||
| Enrollment ICMJE | 301 | ||||
| Completion Date | September 2003 | ||||
| Primary Completion Date | September 2003 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Patients will be excluded from admission to the study if they have/are:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Puerto Rico | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00073021 | ||||
| Responsible Party | Piotr Krzeski, MD, Procter and Gamble Pharmaceuticals | ||||
| Study ID Numbers ICMJE | 200082 | ||||
| Study Sponsor ICMJE | Procter and Gamble | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Procter and Gamble | ||||
| Verification Date | July 2009 | ||||
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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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