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NCT00362856 · ClinicalTrials.gov registry record · Phase 2
Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects
A Phase 2 study, sponsored by 9 Meters Biopharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT00362856: Completed Phase 2 study, sponsored by 9 Meters Biopharma.
NCT00362856 is a Phase 2 study that has completed, run by 9 Meters Biopharma. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00362856, a Phase 2 study, has completed, sponsored by 9 Meters Biopharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
This study was run to determine the safety, tolerance, and efficacy of multiple doses of larazotide acetate in subjects with celiac disease following a gluten challenge.
Primary Outcome
Safety endpoints assessed in this study were adverse events, vital signs, hematology, clinical chemistry, urinalysis and ECG
Interventions
- DRUG Placebo
- DRUG larazotide acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2006-09-13 |
| Est. Completion | 2007-03-06 |
| Phase | Phase 2 |
What the finished NCT00362856 record still lists
NCT00362856 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00362856 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00362856 about?
NCT00362856 is a clinical study titled "Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects". This study was run to determine the safety, tolerance, and efficacy of multiple doses of larazotide acetate in subjects with celiac disease following a gluten challenge.
What is the current status of trial NCT00362856?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2006-09-13. Estimated completion is 2007-03-06.
What interventions are being tested in trial NCT00362856?
The interventions under investigation include: Placebo (DRUG), larazotide acetate (DRUG).
Who is sponsoring clinical trial NCT00362856?
This trial is sponsored by 9 Meters Biopharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00362856's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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