Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects

NCT00362856 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-09-12

No results posted yet for this study

Summary

This study was run to determine the safety, tolerance, and efficacy of multiple doses of larazotide acetate in subjects with celiac disease following a gluten challenge.

Conditions

Interventions

DRUG

larazotide acetate

capsule

DRUG

Placebo

capsule

Sponsors & Collaborators

  • 9 Meters Biopharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-09-13
Primary Completion
2007-03-06
Completion
2007-03-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT00362856 on ClinicalTrials.gov