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

  • STATUS
    Recruiting
  • End date
    Dec 5, 2021
  • participants needed
    630
  • sponsor
    9 Meters Biopharma, Inc.
Updated on 29 November 2020
Investigator
Anh Thu Nguyen
Primary Contact
Research Site (4.0 mi away) Contact
+189 other location
bloating
diarrhea
abdominal pain
gluten
larazotide
serologic test

Summary

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

Description

This is a phase 3, randomized, double-blind, placebo-controlled, multicenter, outpatient study to evaluate the efficacy and safety of larazotide acetate for the relief of persistent symptoms in adult patients with celiac disease on a gluten free diet.

Details
Treatment Matching Placebo, Larazotide
Clinical Study IdentifierNCT03569007
Sponsor9 Meters Biopharma, Inc.
Last Modified on29 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Celiac Disease?
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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Step 2 Get screened

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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