This is a registry record, not a result. A trial being listed, recruiting or completed says nothing by itself about whether the compound works or is safe.
| Registry number | NCT01396213 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | 9 Meters Biopharma, Inc. |
| Enrollment | 342 participants |
| Design | Interventional, Randomized, Parallel, Masking: Double |
| Conditions | Celiac Disease |
| Interventions | Larazotide Acetate; placebo |
| Start | Nov 7, 2011 |
| Primary completion | Aug 20, 2013 |
| Study completion | Aug 20, 2013 |
| Results posted | Not yet |
| Registry last updated | Sep 20, 2017 |
| Collaborators | Teva Pharmaceuticals USA |
Compounds on this site that cite this trial
What the registry says the trial is about
A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.
Primary outcomes
These are what the trial was designed to measure first. They are registered in advance, which is what makes a later result checkable.
| Outcome measure | Time frame |
|---|---|
| Assess the efficacy of larazotide acetate versus placebo for the treatment of celiac disease in adults as an adjunct to a gluten-free diet | CeD GSRS was completed weekly Baseline through the end of 12-week double-blind treatment period. |
3 secondary outcomes also registered. See the registry record for the full list.
Source: ClinicalTrials.gov (U.S. National Library of Medicine). Last checked against the registry on Oct 3, 2026. See the trial changes feed for what has changed recently.
