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NCT00492960 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease
A Phase 2 study, sponsored by 9 Meters Biopharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 171
- Enrollment target
NCT00492960: Completed Phase 2 study, sponsored by 9 Meters Biopharma.
NCT00492960 is a Phase 2 study that has completed, run by 9 Meters Biopharma. The registered enrollment target is 171 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00492960, a Phase 2 study, has completed, sponsored by 9 Meters Biopharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 171 participants
- Enrollment target
Study Summary
This study was conducted to evaluate the efficacy of multiple doses of larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects with celiac disease.
Primary Outcome
The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten
Interventions
- DRUG placebo
- DRUG larazotide acetate
- DIETARY_SUPPLEMENT 900 mg gluten
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
What the finished NCT00492960 record still lists
NCT00492960 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% higher).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00492960 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00492960 about?
NCT00492960 is a clinical study titled "Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease". This study was conducted to evaluate the efficacy of multiple doses of larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects with celiac disease.
What is the current status of trial NCT00492960?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 171 participants. The study started on 2007-08. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00492960?
The interventions under investigation include: placebo (DRUG), larazotide acetate (DRUG), 900 mg gluten (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00492960?
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 NCT00492960's enrollment target sits among peer trials
171 398th of 2000 higher than 1,602 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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