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

  • STATUS
    Recruiting
  • days left to enroll
    70
  • participants needed
    630
  • sponsor
    9 Meters Biopharma, Inc.
Updated on 1 September 2021
Investigator
Anh Thu Nguyen
Primary Contact
Research Site (10.0 mi away) Contact
+217 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
Condition Celiac Disease, celiac, celiac sprue
Treatment Matching Placebo, Larazotide
Clinical Study IdentifierNCT03569007
Sponsor9 Meters Biopharma, Inc.
Last Modified on1 September 2021

Eligibility

Yes No Not Sure

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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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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