Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

What Was Tested

The trial (phase 2) is built around 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 dietary supplement and drug.

More on the Plan

Subjects remained on their gluten-free diet throughout the duration of the trial.

Study drug or drug placebo capsules were administered TID 15 minutes before each meal.

Gluten or gluten placebo capsules will be taken TID with each meal.

Who Took Part

Enrollment: 171 actual participants took part.

It was open to people of any sex aged from 18 years up to 72 years.

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

Examples of who could join: Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months. Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU. BMI between 18.5 and 38, inclusive.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: has chronic active gi disease other than celiac disease; has diabetes (type 1 or type 2); unable to abstain from alcohol consumption or nsaid use for 48 hours prior to each intestinal permeability collection throughout the study.

How the Study Was Run

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

The celiac disease and gluten sensitivity participants were allocated by chance, so the Larazotide group and the comparison group should start out alike.

Groups ran in parallel: each of the celiac disease and gluten sensitivity participants stayed in one arm throughout.

As a double-blind Larazotide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2007-08 with completion listed for 2008-10.

It ran at 23 sites in United States (17) and Canada (6).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example To prospectively validate a composite, weighted index of celiac disease activity.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Larazotide in 171 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.