MedDataX Logo

Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

NCT ID: NCT00889473

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is an extension of Study CLIN1001-006 (NCT 00492960). This is a Phase IIb, randomized, double-blind, placebo-controlled, dose ranging, multicenter study to determine the safety, tolerance, and efficacy of larazotide acetate in subjects with celiac disease during a gluten challenge. Subjects will remain on their gluten-free diet throughout the duration of the trial.

Study drug or drug placebo capsules will be administered TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with each meal.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Celiac Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, double-blind, placebo-controlled, dose ranging, multicenter
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
double-blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Larazotide acetate 1 mg

larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks

Group Type EXPERIMENTAL

Larazotide acetate

Intervention Type DRUG

gelatin capsule

Gluten 900 mg

Intervention Type DIETARY_SUPPLEMENT

gelatin capsule

Placebo

placebo capsules TID + 900 mg gluten capsules TID for 6 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

gelatin capsule

Gluten 900 mg

Intervention Type DIETARY_SUPPLEMENT

gelatin capsule

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Larazotide acetate

gelatin capsule

Intervention Type DRUG

Placebo

gelatin capsule

Intervention Type DRUG

Gluten 900 mg

gelatin capsule

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AT1001 INN-202

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months
* Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU.
* BMI between 18.5 and 38, inclusive.

Exclusion Criteria

* Has chronic active GI disease other than celiac disease
* Has diabetes (Type 1 or Type 2).
* Unable to abstain from alcohol consumption or NSAID use for 48 hours prior to each intestinal permeability collection throughout the study.
* Has hemoglobin value below 8.5 g/dL
Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

9 Meters Biopharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Francisco Leon, MD, PhD

Role: STUDY_DIRECTOR

Alba Therapeutics Inc

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Study Site

Orange, California, United States

Site Status

Study Site

Topeka, Kansas, United States

Site Status

Study Site

Lexington, Kentucky, United States

Site Status

Study Site

Hagerstown, Maryland, United States

Site Status

Study Site

Silver Spring, Maryland, United States

Site Status

Study Site

Chesterfield, Michigan, United States

Site Status

Study Site

Troy, Michigan, United States

Site Status

Study Site

Rochester, Minnesota, United States

Site Status

Study Site

New York, New York, United States

Site Status

Study Site

Oklahoma City, Oklahoma, United States

Site Status

Study Site

Paoli, Pennsylvania, United States

Site Status

Study Site

Philadelphia, Pennsylvania, United States

Site Status

Study Site

Pittsburgh, Pennsylvania, United States

Site Status

Study Site

Franklin, Tennessee, United States

Site Status

Study Site

Edmonton, Alberta, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLIN1001-006 Part B

Identifier Type: -

Identifier Source: org_study_id