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Sponsors and Collaborators: |
University of Nebraska Eli Lilly and Company |
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Information provided by: | University of Nebraska |
ClinicalTrials.gov Identifier: | NCT00742157 |
Treatment for 3.5-8 weeks with GH (0.05 mg/kg/day) +GLN+Diet, followed by continued compliance to the individualized oral diet and enteral GLN, will result in reduced volume of TPN infusion/week and/or reduced frequency of TPN infusions/week.
Condition | Intervention | Phase |
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Short Bowel Syndrome |
Drug: Growth Hormone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Evaluation of the Long-Term Efficacy and Safety of a Standardized Regimen of Growth Hormone, Glutamine and a Modified Diet in the Treatment of Patients With Short Bowel Syndrome |
Estimated Enrollment: | 30 |
Study Start Date: | March 2003 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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UNMC Group: No Intervention
Compare the low and high dose effects of Growth Hormone from previously pooled patients (high dose) and UNMC patients (low dose).
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Drug: Growth Hormone
dosage = 0.05mg/kg/day, in diluent for injection, once a day, for 23 - 54 days.
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Ages Eligible for Study: | 19 Years to 78 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198 |
Principal Investigator: | Fedja Rochling, MB ChB | University of Nebraska |
Responsible Party: | University of Nebraska Medical Center ( Fedja Rochling, MB ChB ) |
Study ID Numbers: | 061-03 |
Study First Received: | August 26, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00742157 |
Health Authority: | United States: Food and Drug Administration |
Growth Hormone TPN Total Parenteral Nutrition |
Glutamine Short Bowel Syndrome Increase in absorption of small bowel. |
Digestive System Diseases Postoperative Complications Gastrointestinal Diseases |
Malabsorption Syndromes Short Bowel Syndrome Intestinal Diseases |
Disease Pathologic Processes Syndrome |