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Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

NCT00889473 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2017-09-20

No results posted yet for this study

Summary

This study is designed to evaluate the efficacy of a single dose of larazotide acetate in preventing intestinal permeability changes induced by a 6-week gluten challenge in subjects with celiac disease

Conditions

Interventions

DRUG

Larazotide acetate

gelatin capsule

DRUG

Placebo

gelatin capsule

DIETARY_SUPPLEMENT

Gluten 900 mg

gelatin capsule

Sponsors & Collaborators

  • 9 Meters Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Francisco Leon, MD, PhD · Alba Therapeutics Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-11-30
Completion
2010-04-30
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00889473 on ClinicalTrials.gov