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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03569007
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	9 Meters Biopharma, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Celiac Disease
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

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

Interventions

Drug: - Larazotide

Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules

Drug: - Matching Placebo

enteric-coated beads in gelatin capsules

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Saraland, Alabama

Status

Withdrawn

Address

Research Site

Saraland, Alabama, 36571

Site Contact

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