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NCT00386165 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Larazotide Acetate to Treat Celiac Disease.
A Phase 1 study, sponsored by 9 Meters Biopharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT00386165: Completed Phase 1 study, sponsored by 9 Meters Biopharma.
NCT00386165 is a Phase 1 study that has completed, run by 9 Meters Biopharma. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00386165, a Phase 1 study, has completed, sponsored by 9 Meters Biopharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
To demonstrate the safety, pharmacokinetics and efficacy of larazotide acetate in patients with controlled celiac disease on a gluten-free diet following a gluten challenge.
Primary Outcome
Safety assessments included scheduled monitoring of adverse events (AEs), vital sign measurements, 12-lead ECG measurements, physical examinations, and clinical laboratory testing (chemistry, hematology, and urinalysis).
Interventions
- DRUG larazotide acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2005-11-29 |
| Est. Completion | 2006-01-26 |
| Phase | Phase 1 |
What the finished NCT00386165 record still lists
NCT00386165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which larazotide acetate is the first listed.
NCT00386165 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00386165 about?
NCT00386165 is a clinical study titled "Safety Study of Larazotide Acetate to Treat Celiac Disease.". To demonstrate the safety, pharmacokinetics and efficacy of larazotide acetate in patients with controlled celiac disease on a gluten-free diet following a gluten challenge.
What is the current status of trial NCT00386165?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2005-11-29. Estimated completion is 2006-01-26.
What interventions are being tested in trial NCT00386165?
The interventions under investigation include: larazotide acetate (DRUG).
Who is sponsoring clinical trial NCT00386165?
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 NCT00386165's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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