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Trial · Interventional

TerminatedPhase 3Registry data

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

NCTNCT03569007 (opens ClinicalTrials.gov in a new tab)Other idCeD-LA-3001
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 3
Enrollment
307 participants (actual)
Sponsor
9 Meters Biopharma, Inc. · Industry
Design
Randomized · Triple masking
Countries
1 country

United States

Start
29 May 2019
Primary completion
21 Jul 2022
Completion
21 Jul 2022
First posted
26 Jun 2018
Last update posted
26 Jul 2022
Conditions
Celiac Disease

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20192020202120222023
  1. Ph 3

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

    NCT03569007

    29 May 2019 to 21 Jul 2022

    Terminated

Registry summary

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

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

Interventions

  • LarazotideDrug
  • Matching PlaceboDrug

Arms3

  • Active comparator

    Larazotide 0.25 mg

    Larazotide 0.25 mg capsules TID

  • Active comparator

    Larazotide 0.50 mg

    Larazotide 0.50 mg capsules TID

  • Placebo comparator

    Placebo

    Matching placebo capsules TID

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Proportion of subjects who are binary responders

    Time frame · 12 weeks

    Registry description

    Reduction in CeD PRO Abdominal Domain scores

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.

A trial that is still running, or that stopped early, may post results later.

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
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male and female adults diagnosed with celiac disease (positive celiac serology plus confirmed biopsy) for at least 6 months * On a gluten-free diet for at least 6 months * Experiencing symptoms (ie, abdominal pain, abdominal cramping, bloating, gas, diarrhea, loose stool, or nausea) * Willing to maintain current gluten-free diet throughout participation in the study Exclusion Criteria: * Refractory celiac disease or severe complications of celiac disease * Chronic active GI disease other than celiac disease

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