A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

What Was Tested

In this phase 2 trial, researchers set out to test Larazotide for celiac disease and gluten sensitivity.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The diagnosis of CD must have been established by jejunal biopsy as well as serology at some point in time prior to entry into the study.

Patients must have symptoms despite being on a gluten-free diet as defined by a celiac disease domain of the gastrointestinal symptoms rating scale equal to or more than 2.0.

Who Took Part

The registry lists 342 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male and female adults with biopsy proven and serology-confirmed celiac disease on a gluten-free diet for at least 12 months. Measurable serology at screening. CeD GSRS score of ≥ 2.0 prior to randomization. Experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nausea, or stomachache). Willing to maintain current diet gluten-free diet throughout the duration of the study.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: refractory celiac disease or severe complications of celiac disease (eg, eatl, ulcerative jejunitis, perforation, etc.); chronic active gi disease other than celiac disease; diabetes (type 1 or 2) or other autoimmune disease that might interfere with the conduct of the study.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Larazotide and who got the comparison, which limits bias.

The Larazotide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the celiac disease and gluten sensitivity participants and researchers unaware of who received Larazotide.

Those kept unaware of assignments: participant and investigator.

It started in 2011-11-07 with completion listed for 2013-08-20.

It ran at 62 sites in United States (56) and Canada (6).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Assess the safety and tolerability of larazotide acetate in subjects with active celiac disease and Validate a CeD PRO diary instrument in subjects with celiac disease.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Larazotide in 342 people with celiac disease and gluten sensitivity.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Larazotide compound page, Celiac disease and gluten sensitivity research.