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NCT01625923 · ClinicalTrials.gov registry record · NA
A Pilot Study on the Efficacy and Safety of Olanzapine in Gastroparesis
A NA study, sponsored by University of Michigan.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT01625923 is a NA study that was terminated before completion, run by University of Michigan. The registered enrollment target is 3 participants.
The verdict
NCT01625923, a NA study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
Gastroparesis is a disorder characterized by impaired gastric emptying in the absence of obstruction in the proximal GI tract. It is a common condition affecting up to 5 million persons in the United States alone. Despite this, metoclopramide is currently the only FDA approved medication for the treatment of gastroparesis. However, the evidence supporting metoclopramide in gastroparesis is fairly weak and was recently issued a black box warning because of potential irreversible side effects. There is clearly an urgent need for newer therapeutic options with better efficacy and tolerability. Olanzapine is a second generation anti-psychotic that is currently FDA approved for the treatment of schizophrenia and bipolar disorder. Because of actions at several receptors throughout the body, including dopamine and serotonin receptors, Olanzapine may provide anti-nausea and pro-motility effects in the stomach. Long-term use of olanzapine may also increase plasma levels of ghrelin. Ghrelin is a hormone produced by the gut that stimulates appetite and has also been shown to have beneficial effects on gastroparesis. The investigators hypothesize that olanzapine will be effective and safe in controlling symptoms as well as stimulate appetite and weight gain in gastroparesis. The investigators also hypothesize that olanzapine will stimulate gastric motility. Finally, the investigators hypothesize that olanzapine will modulate the secretion of ghrelin in gastroparesis. This pilot study may provide further information on the efficacy and safety of olanzapine in gastroparesis which could be utilized in a larger randomized, prospective study in the future.
Interventions
- DRUG Olanzapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2013-01 |
| Est. Completion | 2019-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01625923
The ClinicalTrials.gov registry entry for NCT01625923 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Olanzapine is the first listed.
NCT01625923 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01625923 about?
NCT01625923 is a clinical study titled "A Pilot Study on the Efficacy and Safety of Olanzapine in Gastroparesis". Gastroparesis is a disorder characterized by impaired gastric emptying in the absence of obstruction in the proximal GI tract. It is a common condition affecting up to 5 million persons in the United States alone. Despite this, metoclopramide is currently the only FDA approved medication for the tre...
What is the current status of trial NCT01625923?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2013-01. Estimated completion is 2019-06.
What interventions are being tested in trial NCT01625923?
The interventions under investigation include: Olanzapine (DRUG).
Who is sponsoring clinical trial NCT01625923?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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