Skip to content

Trial · Interventional

CompletedPhase 2Registry data

Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

NCTNCT00889473 (opens ClinicalTrials.gov in a new tab)Other idCLIN1001-006 Part B
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
42 participants (actual)
Sponsor
9 Meters Biopharma, Inc. · Industry
Design
Randomized · Double masking
Countries
2 countries

United States, Canada

Start
Apr 2009
Primary completion
Nov 2009
Completion
Apr 2010
First posted
29 Apr 2009 (estimated)
Last update posted
20 Sept 2017
Conditions
Celiac Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011
  1. Ph 2

    Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

    NCT00889473

    Apr 2009 to Apr 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Larazotide acetateDrug
  • PlaceboDrug
  • Gluten 900 mgDietary supplement

Arms2

  • Experimental

    Larazotide acetate 1 mg

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

  • Placebo comparator

    Placebo

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Response to gluten

    Time frame · 6 weeks

Secondary outcomes(1)

  1. Anti-transglutaminase

    Time frame · 6 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 72 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.