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Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms

NCT03569007 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2022-07-26

No results posted yet for this study

Summary

To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.

Conditions

Interventions

DRUG

Larazotide

Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules

DRUG

Matching Placebo

enteric-coated beads in gelatin capsules

Sponsors & Collaborators

  • 9 Meters Biopharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-29
Primary Completion
2022-07-21
Completion
2022-07-21
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 NCT03569007 on ClinicalTrials.gov