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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03569007
Recruitment Status : Terminated (Trial terminated by Sponsor)
First Posted : June 26, 2018
Last Update Posted : July 26, 2022
Sponsor:
Information provided by (Responsible Party):
9 Meters Biopharma, Inc.

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

Condition or disease Intervention/treatment Phase
Celiac Disease Drug: Larazotide Drug: Matching Placebo Phase 3

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 307 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of Persistent Symptoms in Patients With Celiac Disease on a GFD
Actual Study Start Date : May 29, 2019
Actual Primary Completion Date : July 21, 2022
Actual Study Completion Date : July 21, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Larazotide 0.25 mg
Larazotide 0.25 mg capsules TID
 Drug: Larazotide
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
Other Name: INN-202
Active Comparator: Larazotide 0.50 mg
Larazotide 0.50 mg capsules TID
 Drug: Larazotide
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
Other Name: INN-202
Placebo Comparator: Placebo
Matching placebo capsules TID
 Drug: Matching Placebo
enteric-coated beads in gelatin capsules
Other Name: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects who are binary responders [ Time Frame: 12 weeks ]
    Reduction in CeD PRO Abdominal Domain scores


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569007


Locations
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Sponsors and Collaborators
9 Meters Biopharma, Inc.
More Information
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Additional Information:

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Responsible Party: 9 Meters Biopharma, Inc.
ClinicalTrials.gov Identifier: NCT03569007    
Other Study ID Numbers: CeD-LA-3001
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: July 26, 2022
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases