- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01396213
A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease
September 15, 2017 updated by: 9 Meters Biopharma, Inc.
A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease
A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of three different doses (0.5, 1 and 2 mg TID) of Larazotide Acetate as an adjunct to gluten-free diet in the treatment of patients with celiac disease (CD).
The diagnosis of CD must have been established by jejunal biopsy as well as serology at some point in time prior to entry into the study.
Patients must have symptoms despite being on a gluten-free diet as defined by a celiac disease domain of the gastrointestinal symptoms rating scale equal to or more than 2.0.
Study Type
Interventional
Enrollment (Actual)
342
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G2X8
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British Columbia
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Abbotsford, British Columbia, Canada, V2T3R7
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Kelowna, British Columbia, Canada, V1Y1Z9
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Vancouver, British Columbia, Canada, V6Z2K5
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Victoria, British Columbia, Canada, V8V3P9
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Ontario
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Hamilton, Ontario, Canada, L854J9
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Alabama
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Birmingham, Alabama, United States, 35209
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Arizona
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Mesa, Arizona, United States, 85206
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Tucson, Arizona, United States, 85704
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California
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Oceanside, California, United States, 92056
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Orange, California, United States, 92868
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San Francisco, California, United States, 94115
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Santa Monica, California, United States, 90404
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Walnut Creek, California, United States, 94598
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Colorado
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Denver, Colorado, United States, 80222
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Florida
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Boynton Beach, Florida, United States, 33426
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Edgewater, Florida, United States, 32132
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Orlando, Florida, United States, 32806
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Summerfield, Florida, United States, 34491
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Georgia
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Marietta, Georgia, United States, 30067
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Illinois
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Chicago, Illinois, United States, 60612
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Rockford, Illinois, United States, 61107
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Iowa
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West Des Moines, Iowa, United States, 50266
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Kansas
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Wichita, Kansas, United States, 67207
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Kentucky
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Lexington, Kentucky, United States, 40536
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Louisville, Kentucky, United States, 40202
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Maryland
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Baltimore, Maryland, United States, 21229
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Hagerstown, Maryland, United States, 21742
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Massachusetts
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Boston, Massachusetts, United States, 02215
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Michigan
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Chesterfield, Michigan, United States, 48047
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Wyoming, Michigan, United States, 49519
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Minnesota
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Duluth, Minnesota, United States, 55805
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Rochester, Minnesota, United States, 55905
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Mississippi
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Jackson, Mississippi, United States, 39202
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Missouri
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Saint Louis, Missouri, United States, 63141
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Montana
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Missoula, Montana, United States, 59808
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Nevada
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Las Vegas, Nevada, United States, 89119
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New Jersey
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Marlton, New Jersey, United States, 08053
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New York
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Lake Success, New York, United States, 11042
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New York, New York, United States, 10016
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New York, New York, United States, 10032
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Rochester, New York, United States, 14618
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North Carolina
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Cary, North Carolina, United States, 27518
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Salisbury, North Carolina, United States, 28144
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Winston-Salem, North Carolina, United States, 27103
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Ohio
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Cleveland, Ohio, United States, 44195
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Mentor, Ohio, United States, 44060
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73160
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Oregon
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Portland, Oregon, United States, 97210
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Pennsylvania
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Bethlehem, Pennsylvania, United States, 18017
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Perkasie, Pennsylvania, United States, 18944
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Philadelphia, Pennsylvania, United States, 19107
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Pittsburgh, Pennsylvania, United States, 15243
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Rhode Island
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Warwick, Rhode Island, United States, 02886
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Tennessee
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Chattanooga, Tennessee, United States, 37421
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Texas
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Dallas, Texas, United States, 75321
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San Antonio, Texas, United States, 78229
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Utah
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Saint George, Utah, United States, 84790
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Salt Lake City, Utah, United States, 84109
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Virginia
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Alexandria, Virginia, United States, 22304
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Charlottesville, Virginia, United States, 22911
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Washington
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Seattle, Washington, United States, 98104
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female adults with biopsy proven and serology-confirmed celiac disease on a gluten-free diet for at least 12 months
- measurable serology at screening
- CeD GSRS score of ≥ 2.0 prior to randomization
- experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nausea, or stomachache)
- willing to maintain current diet gluten-free diet throughout the duration of the study.
Exclusion Criteria:
- refractory celiac disease or severe complications of celiac disease (eg, EATL, ulcerative jejunitis, perforation, etc.)
- chronic active GI disease other than celiac disease
- diabetes (Type 1 or 2) or other autoimmune disease that might interfere with the conduct of the study
- hemoglobin value < 8.5 g/dL
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Larazotide Acetate 0.5 mg
larazotide acetate 0.5 mg capsules TID
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gelatin capsule
Other Names:
|
Experimental: Larazotide Acetate 1 mg
larazotide acetate 1 mg capsules TID
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gelatin capsule
Other Names:
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Experimental: Larazotide Acetate 2 mg
larazotide acetate 2 mg capsules TID
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gelatin capsule
Other Names:
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Placebo Comparator: Placebo
placebo capsules TID
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gelatin capsule
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the efficacy of larazotide acetate versus placebo for the treatment of celiac disease in adults as an adjunct to a gluten-free diet
Time Frame: CeD GSRS was completed weekly Baseline through the end of 12-week double-blind treatment period.
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The primary efficacy endpoint was average on-treatment (Baseline to Week 12) score of theCeliac Disease Gastrointestinal Symptom Rating Scale (CeD GSRS).
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CeD GSRS was completed weekly Baseline through the end of 12-week double-blind treatment period.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the safety and tolerability of larazotide acetate in subjects with active celiac disease
Time Frame: Up to 12 weeks
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Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results, concomitant medication usage and ECG results
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Up to 12 weeks
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Validate a CeD PRO diary instrument in subjects with celiac disease
Time Frame: The CeD PRO was administered daily throughout the study.
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The CeD PRO is a 12-item questionnaire that was developed to assess symptom severity in clinical trials in subjects with celiac disease.
Items in the questionnaire were formulated based on one-on-one interviews with subjects with celiac disease and thus reflect the symptoms that subjects consider part of their celiac disease experience.
Subjects rated their symptom severity on an 11-point (0-10) scale.
Symptoms included abdominal cramping, abdominal pain, bloating, constipation, diarrhea, gas, loose stools, nausea, vomiting, headache, and tiredness.
The questionnaire was designed as a self-administered daily diary, to be completed at the same time each day, and required < 10 minutes to complete.
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The CeD PRO was administered daily throughout the study.
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Compare various efficacy endpoints during 12 weeks of double-blind treatment
Time Frame: GSRS - weekly; BSFS - daily; CGA - screening, baseline, Week 12 and follow-up visits; CeD-QoL and SF12v2 - start of placebo run-in, Week 12 and follow-up visits; CD and CFDCQ - follow-up visit.
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Additional efficacy assessments comprised a variety of known scales used for evaluating subjects with celiac disease, including the Gastrointestinal Symptoms Rating Scale (GSRS), Bristol Stool Form Scale (BSFS), Short Form 12 health survey Version 2 (SF12v2), Celiac Disease Quality of Life (CeD-QoL) scale, and the Clinical Global Assessment (CGA).
A Gluten-Free Diet Compliance Questionnaire (GFDCQ) and Celiac Dietary Adherence Test (CDAT) were also included to assess compliance with the gluten-free diet.
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GSRS - weekly; BSFS - daily; CGA - screening, baseline, Week 12 and follow-up visits; CeD-QoL and SF12v2 - start of placebo run-in, Week 12 and follow-up visits; CD and CFDCQ - follow-up visit.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Henrik Rasmussen, MD, PhD, Sponsor GmbH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 7, 2011
Primary Completion (Actual)
August 20, 2013
Study Completion (Actual)
August 20, 2013
Study Registration Dates
First Submitted
July 14, 2011
First Submitted That Met QC Criteria
July 15, 2011
First Posted (Estimate)
July 18, 2011
Study Record Updates
Last Update Posted (Actual)
September 20, 2017
Last Update Submitted That Met QC Criteria
September 15, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Clin1001-012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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