Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms

What Was Tested

The trial (phase 3) is built around Larazotide for celiac disease and gluten sensitivity.

It had three arms (groups): one (active comparator), one (active comparator) and Placebo (placebo comparator).

Matching placebo capsules TID.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 307 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Male and female adults diagnosed with celiac disease (positive celiac serology plus confirmed biopsy) for at least 6 months. On a gluten-free diet for at least 6 months. Experiencing symptoms (ie, abdominal pain, abdominal cramping, bloating, gas, diarrhea, loose stool, or nausea). Willing to maintain current gluten-free diet throughout participation in the study.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: refractory celiac disease or severe complications of celiac disease; chronic active gi disease other than celiac disease.

How the Study Was Run

Design: randomized, parallel-group and triple-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.

Neither the celiac disease and gluten sensitivity participants nor the staff measuring them knew who was on Larazotide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2019-05-29 with completion listed for 2022-07-21.

It ran at 160 sites in United States (160).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Proportion of subjects who are binary responders (time frame: 12 weeks).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Larazotide in 307 people with celiac disease and gluten sensitivity.

It ended early (terminated); 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.