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NCT00976443 · ClinicalTrials.gov registry record · Phase 1
Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00976443: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT00976443 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00976443, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
Obesity is an important public health problem in the United States. The investigators hypothesize that stomach injections of botulinum toxin A (BTA), delivered through an endoscope using endoscopic ultrasound (EUS), may cause delayed gastric emptying, satiation, and reduction in body weight. This protocol is designed to study the effects and safety of gastric BTA injections. Subjects are randomized to receive placebo or one of two different doses of BTA injected into the stomach during one endoscopy, performed via the mouth. Gastric emptying, satiation, symptoms, psychological dimensions of eating behavior, and caloric intake are recorded before and after injections, and subjects are seen in follow-up for 24 weeks.
Interventions
- DRUG BTA
- DRUG Placebo (normal saline)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2009-09 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00976443
The ClinicalTrials.gov registry entry for NCT00976443 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which BTA is the first listed.
NCT00976443 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00976443 about?
NCT00976443 is a clinical study titled "Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects". Obesity is an important public health problem in the United States. The investigators hypothesize that stomach injections of botulinum toxin A (BTA), delivered through an endoscope using endoscopic ultrasound (EUS), may cause delayed gastric emptying, satiation, and reduction in body weight. This pr...
What is the current status of trial NCT00976443?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2009-09. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00976443?
The interventions under investigation include: BTA (DRUG), Placebo (normal saline) (DRUG).
Who is sponsoring clinical trial NCT00976443?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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