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Trial · Interventional

CompletedPhase 2Registry data

Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

NCTNCT00492960 (opens ClinicalTrials.gov in a new tab)Other idCLIN1001-006
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States, Canada

Start
Aug 2007
Primary completion
Oct 2008
Completion
Mar 2009
First posted
27 Jun 2007 (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
2007200820092010
  1. Ph 2

    Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

    NCT00492960

    Aug 2007 to Mar 2009

Registry summary

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

This study was conducted to evaluate the efficacy of multiple doses of larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects with celiac disease.

Interventions

  • larazotide acetateDrug
  • placeboDrug
  • 900 mg glutenDietary supplement

Arms4

  • Experimental

    Larazotide acetate 1 mg

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

  • Experimental

    Larazotide acetate 4 mg

    larazotide acetate 4 mg capsules TID + 900 mg gluten capsules TID for 6 weeks

  • Experimental

    Larazotide acetate 8 mg

    larazotide acetate 8 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. Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.

    Time frame · Following ingestion of a solution of lactulose and mannitol; lactulose and mannitol excretion was quantified and the LAMA ratio calculated from overnight urine specimens collected on Days 7, 21, 35, 49 and 56.

    Registry description

    The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten

Secondary outcomes(2)

  1. Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals

    Time frame · Up to 6 weeks

    Registry description

    Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results, concomitant medication usage and ECG results

  2. To prospectively validate a composite, weighted index of celiac disease activity

    Time frame · GSRS was completed weekly throughout the study.

    Registry description

    Gastrointestinal symptoms were assessed by the GSRS patient self-assessment questionnaire

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2013

6 results

Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study.

Kelly et al. 2013Alimentary pharmacology & therapeuticscited by 147

PMID 23163616DOI 10.1111/apt.12147PUB-23163616

Full text at the publisher6 results
Publisher pageSee results (6)

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

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