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| Tracking Information | |||||||||
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| First Received Date ICMJE | March 14, 2001 | ||||||||
| Last Updated Date | January 20, 2009 | ||||||||
| Start Date ICMJE | April 1999 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00013312 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effects of Acute SCI on Colonic Motility & Tone | ||||||||
| Official Title ICMJE | Effects of Acute SCI on Colonic Motility & Tone | ||||||||
| Brief Summary | This study will compare individuals with acute SCI to control patients in order to: 1. Determine if there are changes in colonic tone and sensation after SCI by comparing the fasting responses to the postprandial responses; 2. Determine if there are changes in colonic phasic motility after SCI by comparing the fasting responses to the postprandial responses; 3. Determine if colonic motor and sensory function after SCI change over time by repeating these studies six month later in SCI and control patients. |
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| Detailed Description | |||||||||
| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Diagnostic, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Spinal Cord Injury | ||||||||
| Intervention ICMJE | Procedure: Determine colonic tone | ||||||||
| 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 | Completed | ||||||||
| Enrollment ICMJE | 12 | ||||||||
| Completion Date | March 2001 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Acute SCI with impaired colonic tone |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00013312 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | B1862R | ||||||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||||||
| Verification Date | January 2001 | ||||||||
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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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