NCT01396213

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

A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: 9 Meters Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.

Detailed description

This is a double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of three different doses (0.5, 1 and 2 mg TID) of Larazotide Acetate as an adjunct to gluten-free diet in the treatment of patients with celiac disease (CD). 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.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DRUG	Larazotide Acetate	gelatin capsule
DRUG	placebo	gelatin capsule

Timeline

• Start date: 2011-11-07
• Primary completion: 2013-08-20
• Completion: 2013-08-20
• First posted: 2011-07-18
• Last updated: 2017-09-20

Locations

62 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study