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Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

NCT00492960 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2017-09-20

No results posted yet for this study

Summary

This study was conducted to evaluate the efficacy of multiple doses 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 capsules

DRUG

placebo

gelatin capsules

DIETARY_SUPPLEMENT

900 mg gluten

gelatin capsules

Sponsors & Collaborators

  • 9 Meters Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Francisco Leon, MD, Ph.D. · Alba Therapeutics Corp

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
2007-08-31
Primary Completion
2008-10-31
Completion
2009-03-31
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 NCT00492960 on ClinicalTrials.gov