Clinical trial NCT03569007: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Celiac Disease
Lead sponsor: 9 Meters Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-26
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of subjects who are binary responders
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saraland
country: United States
facility: Research Site
state: Alabama
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
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state: Arizona
city: North Little Rock
country: United States
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state: Arkansas
city: Bellflower
country: United States
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state: California
city: Beverly Hills
country: United States
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state: California
city: Canoga Park
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state: California
city: Corona
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city: Garden Grove
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city: Lancaster
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state: California
city: Los Gatos
country: United States
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city: Northridge
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state: California
city: Poway
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city: Rialto
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state: California
city: San Diego
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city: San Diego
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city: San Francisco
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city: Walnut Creek
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city: Bristol
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city: Stamford
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city: Stockbridge
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city: Idaho Falls
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city: Arlington Heights
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city: Fairview Heights
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city: Melrose Park
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city: Morton
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city: Clive
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city: Iowa City
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city: West Des Moines
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city: Topeka
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city: Lexington
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city: Lexington
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city: Columbia
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city: Fall River
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city: Rochester
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city: Rochester
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city: Jefferson City
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city: Saint Louis
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city: Omaha
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city: Omaha
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city: Las Vegas
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city: Las Vegas
country: United States
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city: Las Vegas
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state: Nevada
city: Las Vegas
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city: Reno
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state: Nevada
city: Portsmouth
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state: New Hampshire
city: Freehold
country: United States
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state: New Jersey
city: Ocean Township
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city: Albuquerque
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city: Great Neck
country: United States
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state: New York
city: Mineola
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city: New Windsor
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city: New York
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city: Charlotte
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city: Columbus
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city: Poland
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city: Oklahoma City
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city: Philadelphia
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city: Sioux Falls
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city: Chattanooga
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city: Nashville
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city: Austin
country: United States
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city: Austin
country: United States
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state: Texas
city: Austin
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city: Austin
country: United States
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city: Austin
country: United States
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city: Cypress
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country: United States
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country: United States
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city: Harlingen
country: United States
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city: Houston
country: United States
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state: Texas
city: Houston
country: United States
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city: Houston
country: United States
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city: McAllen
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Sugar Land
country: United States
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city: Sugar Land
country: United States
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state: Texas
city: Victoria
country: United States
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state: Texas
city: Ogden
country: United States
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state: Utah
city: Ogden
country: United States
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state: Utah
city: Saint George
country: United States
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state: Utah
city: Salt Lake City
country: United States
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state: Utah
city: Sandy
country: United States
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city: Chesapeake
country: United States
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state: Virginia
city: Fairfax
country: United States
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state: Virginia
city: Gainesville
country: United States
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state: Virginia
city: Lansdowne Town Center
country: United States
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state: Virginia
city: Lynchburg
country: United States
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state: Virginia
city: Norfolk
country: United States
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state: Virginia
city: Bellevue
country: United States
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state: Washington
city: Bellevue
country: United States
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state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
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state: Washington
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Vancouver
country: United States
facility: Research Site
state: Washington
city: Wauwatosa
country: United States
facility: Research Site
state: Wisconsin
Study officials:
References: