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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT01396213

Public ClinicalTrials.gov record NCT01396213. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 8:27 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01396213
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
9 Meters Biopharma, Inc.
Industry
Enrollment
342 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 7, 2011 (Actual)
Primary completion
Aug 20, 2013 (Actual)
Completion
Aug 20, 2013 (Actual)
Last update posted
Sep 20, 2017

2011 – 2013

United States locations

U.S. sites
56
U.S. states
31
U.S. cities
55
Facility City State ZIP Site status
Not listed Birmingham Alabama 35209 —
Not listed Mesa Arizona 85206 —
Not listed Tucson Arizona 85704 —
Not listed Oceanside California 92056 —
Not listed Orange California 92868 —
Not listed San Francisco California 94115 —
Not listed Santa Monica California 90404 —
Not listed Walnut Creek California 94598 —
Not listed Denver Colorado 80222 —
Not listed Boynton Beach Florida 33426 —
Not listed Edgewater Florida 32132 —
Not listed Orlando Florida 32806 —
Not listed Summerfield Florida 34491 —
Not listed Marietta Georgia 30067 —
Not listed Chicago Illinois 60612 —
Not listed Rockford Illinois 61107 —
Not listed West Des Moines Iowa 50266 —
Not listed Wichita Kansas 67207 —
Not listed Lexington Kentucky 40536 —
Not listed Louisville Kentucky 40202 —
Not listed Baltimore Maryland 21229 —
Not listed Hagerstown Maryland 21742 —
Not listed Boston Massachusetts 02215 —
Not listed Chesterfield Michigan 48047 —
Not listed Wyoming Michigan 49519 —
Not listed Duluth Minnesota 55805 —
Not listed Rochester Minnesota 55905 —
Not listed Jackson Mississippi 39202 —
Not listed St Louis Missouri 63141 —
Not listed Missoula Montana 59808 —
Not listed Las Vegas Nevada 89119 —
Not listed Marlton New Jersey 08053 —
Not listed Lake Success New York 11042 —
Not listed New York New York 10016 —
Not listed New York New York 10032 —
Not listed Rochester New York 14618 —
Not listed Cary North Carolina 27518 —
Not listed Salisbury North Carolina 28144 —
Not listed Winston-Salem North Carolina 27103 —
Not listed Cleveland Ohio 44195 —
Not listed Mentor Ohio 44060 —
Not listed Oklahoma City Oklahoma 73160 —
Not listed Portland Oregon 97210 —
Not listed Bethlehem Pennsylvania 18017 —
Not listed Perkasie Pennsylvania 18944 —
Not listed Philadelphia Pennsylvania 19107 —
Not listed Pittsburgh Pennsylvania 15243 —
Not listed Warwick Rhode Island 02886 —
Not listed Chattanooga Tennessee 37421 —
Not listed Dallas Texas 75321 —
Not listed San Antonio Texas 78229 —
Not listed Salt Lake City Utah 84109 —
Not listed St. George Utah 84790 —
Not listed Alexandria Virginia 22304 —
Not listed Charlottesville Virginia 22911 —
Not listed Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01396213, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 20, 2017 · Synced Oct 19, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01396213 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →