Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects

What Was Tested

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

It had seven arms (groups): Placebo + Gluten (placebo comparator), Placebo + Gluten placebo (placebo comparator), one (other), one (active comparator) and one (active comparator).

Placebo TID + gluten placebo TID administered orally in capsules.

The registry classes the interventions as drug.

More on the Plan

Drug or drug placebo was administered TID 15 minutes prior to each main meal.

Subjects received their assigned treatments for two weeks (Day 0 through Day 14) and came to clinic for a follow-up visit one week later (Day 21).

Subjects remained on their gluten-free diet for the duration of the study.

Who Took Part

80 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Must have been diagnosed with celiac disease by biopsy for ≥ 6 months. Have a Anti-Tissue Transglutaminase (tTG) ≤ 10 EU as measured by serology. Must be on a gluten-free diet for at least the past 6 months.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: have any chronic active gi disease other than celiac disease (e.g., ibs, crohn's, colitis); have diabetes (type 1 or type 2); chronically consumes non-steroidal anti-inflammatory agents ("nsaids") or takes proton-pump inhibitors.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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 2006-09-13 with completion listed for 2007-03-06.

It ran at 9 sites in United States (9).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 8 secondary outcomes, for example Changes in daily and weekly reported health outcomes, Changes in urinary LAMA ratios between Day 0 to Day 7, Changes in urinary lactulose fractional excretion between Day 0 to Day 7 to Day 14, Changes in urinary mannitol fractional excretion between Day 0 to Day 7 to Day 14, Change in urinary nitrite / nitrate levels from Day 0 to Day 14 and Change in anti-tTG levels from Screening to Day 21.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Larazotide in 80 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.