Back to resultsStudy to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
Primary Purpose
Celiac Disease
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Larazotide
Matching Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Celiac Disease
Eligibility 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Larazotide 0.25 mg
Larazotide 0.50 mg
Placebo
Arm Description
Larazotide 0.25 mg capsules TID
Larazotide 0.50 mg capsules TID
Matching placebo capsules TID
Outcomes
Primary Outcome Measures
Proportion of subjects who are binary responders
Reduction in CeD PRO Abdominal Domain scores
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03569007
Brief Title
Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Trial terminated by Sponsor
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
July 21, 2022 (Actual)
Study Completion Date
July 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
9 Meters Biopharma, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
307 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Larazotide 0.25 mg
Arm Type
Active Comparator
Arm Description
Larazotide 0.25 mg capsules TID
Arm Title
Larazotide 0.50 mg
Arm Type
Active Comparator
Arm Description
Larazotide 0.50 mg capsules TID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo capsules TID
Intervention Type
Drug
Intervention Name(s)
Larazotide
Other Intervention Name(s)
INN-202
Intervention Description
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Other Intervention Name(s)
placebo
Intervention Description
enteric-coated beads in gelatin capsules
Primary Outcome Measure Information:
Title
Proportion of subjects who are binary responders
Description
Reduction in CeD PRO Abdominal Domain scores
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Research Site
City
Saraland
State/Province
Alabama
ZIP/Postal Code
36571
Country
United States
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
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United States
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Research Site
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
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Research Site
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
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Research Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
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Research Site
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
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Research Site
City
Corona
State/Province
California
ZIP/Postal Code
92879
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United States
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Research Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
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United States
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Research Site
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
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United States
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Research Site
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
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United States
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Research Site
City
Northridge
State/Province
California
ZIP/Postal Code
91324
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United States
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Research Site
City
Poway
State/Province
California
ZIP/Postal Code
92064
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United States
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Research Site
City
Rialto
State/Province
California
ZIP/Postal Code
92377
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United States
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Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92013
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United States
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Research Site
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San Diego
State/Province
California
ZIP/Postal Code
92103
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United States
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Research Site
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San Francisco
State/Province
California
ZIP/Postal Code
94102
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United States
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Research Site
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Walnut Creek
State/Province
California
ZIP/Postal Code
94598
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United States
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Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
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United States
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Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
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United States
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Research Site
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Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
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United States
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Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
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United States
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Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
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United States
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Clearwater
State/Province
Florida
ZIP/Postal Code
33756
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United States
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Inverness
State/Province
Florida
ZIP/Postal Code
34452
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United States
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Research Site
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Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
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United States
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Research Site
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Miami
State/Province
Florida
ZIP/Postal Code
33133
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United States
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Research Site
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Orange Park
State/Province
Florida
ZIP/Postal Code
32073
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United States
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Research Site
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Orlando
State/Province
Florida
ZIP/Postal Code
32803
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United States
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Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
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United States
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Port Orange
State/Province
Florida
ZIP/Postal Code
32127
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United States
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Atlanta
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Georgia
ZIP/Postal Code
30328
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United States
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Columbus
State/Province
Georgia
ZIP/Postal Code
31904
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United States
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Macon
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Georgia
ZIP/Postal Code
31201
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United States
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Stockbridge
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Georgia
ZIP/Postal Code
30281
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United States
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Stone Mountain
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Georgia
ZIP/Postal Code
30083
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United States
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Sugar Hill
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Georgia
ZIP/Postal Code
30518
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United States
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Boise
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Idaho
ZIP/Postal Code
83706
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United States
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Idaho Falls
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Idaho
ZIP/Postal Code
83404
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United States
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Arlington Heights
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Illinois
ZIP/Postal Code
60005
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United States
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Fairview Heights
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Illinois
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62208
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United States
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Melrose Park
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Illinois
ZIP/Postal Code
60160
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United States
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Morton
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Illinois
ZIP/Postal Code
61550
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United States
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Clive
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Iowa
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50325
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United States
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Iowa City
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Iowa
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52242
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United States
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West Des Moines
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Iowa
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50266
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United States
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Topeka
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Kansas
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66606
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United States
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Lexington
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Kentucky
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40509
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United States
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Lexington
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Kentucky
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40536
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United States
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Louisville
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Kentucky
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40202
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United States
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Crowley
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Louisiana
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70526
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United States
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Lafayette
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Louisiana
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70503
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United States
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Marrero
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Louisiana
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70072
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United States
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Metairie
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Louisiana
ZIP/Postal Code
70006
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United States
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New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
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United States
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New Orleans
State/Province
Louisiana
ZIP/Postal Code
70125
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United States
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Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
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United States
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City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
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United States
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Research Site
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
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United States
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Research Site
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
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Research Site
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
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Research Site
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02723
Country
United States
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Research Site
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
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Research Site
City
Rochester
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
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Research Site
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
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Research Site
City
Jackson
State/Province
Minnesota
ZIP/Postal Code
39216
Country
United States
Facility Name
Research Site
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55117
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United States
Facility Name
Research Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Research Site
City
Petal
State/Province
Mississippi
ZIP/Postal Code
39465
Country
United States
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Research Site
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Research Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Research Site
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Research Site
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Research Site
City
Ocean Township
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Research Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Research Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Research Site
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
11419
Country
United States
Facility Name
Research Site
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Research Site
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Research Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Research Site
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Research Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
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United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
04323
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United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
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United States
Facility Name
Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Facility Name
Research Site
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
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United States
Facility Name
Research Site
City
Poland
State/Province
Ohio
ZIP/Postal Code
44514
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United States
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Research Site
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
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United States
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Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
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United States
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Research Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
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United States
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Research Site
City
Happy Valley
State/Province
Oregon
ZIP/Postal Code
97086
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United States
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Research Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
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United States
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Research Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
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United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
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United States
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Research Site
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
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United States
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Research Site
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18508
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United States
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Research Site
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
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United States
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Research Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
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United States
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Research Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
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United States
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Research Site
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
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United States
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Research Site
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
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United States
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Research Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
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United States
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Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
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United States
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Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
77024
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United States
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Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
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United States
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Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78726
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United States
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Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
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United States
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Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
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United States
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Research Site
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
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United States
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Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75224
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United States
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Research Site
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
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United States
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Research Site
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
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United States
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Research Site
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Research Site
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77476
Country
United States
Facility Name
Research Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Research Site
City
Victoria
State/Province
Texas
ZIP/Postal Code
77904
Country
United States
Facility Name
Research Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Research Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Research Site
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Research Site
City
Sandy
State/Province
Utah
ZIP/Postal Code
84092
Country
United States
Facility Name
Research Site
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Research Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Research Site
City
Gainesville
State/Province
Virginia
ZIP/Postal Code
20155
Country
United States
Facility Name
Research Site
City
Lansdowne Town Center
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States
Facility Name
Research Site
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Research Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Research Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Research Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Research Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Research Site
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Research Site
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
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