Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

What Was Tested

This registered phase 2 trial tested Larazotide for celiac disease and gluten sensitivity.

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

The registry classes the interventions as dietary supplement and drug.

More on the Plan

This study is an extension of Study CLIN1001-006 (NCT 00492960).

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

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

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

Who Took Part

The registry lists 42 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

The set-up was 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.

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

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 2009-04 with completion listed for 2009-11.

It ran at 15 sites in United States (14) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Response to gluten (time frame: 6 weeks).

It also tracked 1 secondary outcome, for example Anti-transglutaminase.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Larazotide in 42 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.