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NCT01380366 · ClinicalTrials.gov registry record · Phase 4
rHGH and Intestinal Permeability in Intestinal Failure
A Phase 4 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT01380366: Completed Phase 4 study, sponsored by Northwestern University.
NCT01380366 is a Phase 4 study that has completed, run by Northwestern University. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01380366, a Phase 4 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
Patients who are being asked to participate in this study have a short small bowel and will be prescribed to take the medication: Zorbtive® ("Zorbtive/Somatropin/(rHGH)"). Zorbtive® is an FDA approved recombinant human growth hormone (rHGH). The investigators want to see if taking this medication improves small bowel function by helping it to take in food, nutrients, vitamins and minerals. The investigators also believe that if the small bowel is absorbing food and nutrients better, liver function will improve as well. Therefore, liver function will also be monitored during the course of the study by performing blood tests.
Primary Outcome
Permeability changes will be identified in short bowel syndrome patients by evaluating concentration of lactulose, mannitol and sucralose from Visit 1 to Visit 2. A decrease in concentration of sucralose in urine indicates Zorbtive potentially enhancing intestinal barrier function.
Interventions
- OTHER Fasting
- DRUG Somatropin
- PROCEDURE Seven Day Food Diary
- PROCEDURE Blood Tests (standard of care)
- OTHER Sugar Permeability Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2006-10 |
| Est. Completion | 2015-02 |
| Phase | Phase 4 |
What the finished NCT01380366 record still lists
NCT01380366 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 5 interventions - of which Fasting is the first listed.
NCT01380366 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01380366 about?
NCT01380366 is a clinical study titled "rHGH and Intestinal Permeability in Intestinal Failure". Patients who are being asked to participate in this study have a short small bowel and will be prescribed to take the medication: Zorbtive® ("Zorbtive/Somatropin/(rHGH)"). Zorbtive® is an FDA approved recombinant human growth hormone (rHGH). The investigators want to see if taking this medication im...
What is the current status of trial NCT01380366?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2006-10. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01380366?
The interventions under investigation include: Fasting (OTHER), Somatropin (DRUG), Seven Day Food Diary (PROCEDURE), Blood Tests (standard of care) (PROCEDURE), Sugar Permeability Test (OTHER).
Who is sponsoring clinical trial NCT01380366?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01380366's enrollment target sits among peer trials
15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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