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Safety Study of Larazotide Acetate to Treat Celiac Disease.

NCT00386165 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-09-11

No results posted yet for this study

Summary

To demonstrate the safety, pharmacokinetics and efficacy of larazotide acetate in patients with controlled celiac disease on a gluten-free diet following a gluten challenge.

Conditions

Interventions

DRUG

larazotide acetate

larazotide acetate 4 mg capsules

Sponsors & Collaborators

  • 9 Meters Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Blake Paterson, MD · Alba Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-11-29
Primary Completion
2006-01-26
Completion
2006-01-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00386165 on ClinicalTrials.gov