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A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

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. Identifier: NCT01396213
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : September 20, 2017
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Innovate Biopharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Celiac Disease Drug: Larazotide Acetate Drug: placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 342 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double-blind, placebo-controlled
Masking: Double (Participant, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 7, 2011
Actual Primary Completion Date : August 20, 2013
Actual Study Completion Date : August 20, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Experimental: Larazotide Acetate 0.5 mg
larazotide acetate 0.5 mg capsules TID
Drug: Larazotide Acetate
gelatin capsule
Other Names:
  • AT-1001
  • INN-202

Experimental: Larazotide Acetate 1 mg
larazotide acetate 1 mg capsules TID
Drug: Larazotide Acetate
gelatin capsule
Other Names:
  • AT-1001
  • INN-202

Experimental: Larazotide Acetate 2 mg
larazotide acetate 2 mg capsules TID
Drug: Larazotide Acetate
gelatin capsule
Other Names:
  • AT-1001
  • INN-202

Placebo Comparator: Placebo
placebo capsules TID
Drug: placebo
gelatin capsule

Primary Outcome Measures :
  1. 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. ]
    The primary efficacy endpoint was average on-treatment (Baseline to Week 12) score of theCeliac Disease Gastrointestinal Symptom Rating Scale (CeD GSRS).

Secondary Outcome Measures :
  1. Assess the safety and tolerability of larazotide acetate in subjects with active celiac disease [ Time Frame: Up to 12 weeks ]
    Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results, concomitant medication usage and ECG results

  2. Validate a CeD PRO diary instrument in subjects with celiac disease [ Time Frame: The CeD PRO was administered daily throughout the study. ]
    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.

  3. 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. ]
    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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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01396213

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States, 35209
United States, Arizona
Mesa, Arizona, United States, 85206
Tucson, Arizona, United States, 85704
United States, California
Oceanside, California, United States, 92056
Orange, California, United States, 92868
San Francisco, California, United States, 94115
Santa Monica, California, United States, 90404
Walnut Creek, California, United States, 94598
United States, Colorado
Denver, Colorado, United States, 80222
United States, Florida
Boynton Beach, Florida, United States, 33426
Edgewater, Florida, United States, 32132
Orlando, Florida, United States, 32806
Summerfield, Florida, United States, 34491
United States, Georgia
Marietta, Georgia, United States, 30067
United States, Illinois
Chicago, Illinois, United States, 60612
Rockford, Illinois, United States, 61107
United States, Iowa
West Des Moines, Iowa, United States, 50266
United States, Kansas
Wichita, Kansas, United States, 67207
United States, Kentucky
Lexington, Kentucky, United States, 40536
Louisville, Kentucky, United States, 40202
United States, Maryland
Baltimore, Maryland, United States, 21229
Hagerstown, Maryland, United States, 21742
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Michigan
Chesterfield, Michigan, United States, 48047
Wyoming, Michigan, United States, 49519
United States, Minnesota
Duluth, Minnesota, United States, 55805
Rochester, Minnesota, United States, 55905
United States, Mississippi
Jackson, Mississippi, United States, 39202
United States, Missouri
Saint Louis, Missouri, United States, 63141
United States, Montana
Missoula, Montana, United States, 59808
United States, Nevada
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Marlton, New Jersey, United States, 08053
United States, New York
Lake Success, New York, United States, 11042
New York, New York, United States, 10016
New York, New York, United States, 10032
Rochester, New York, United States, 14618
United States, North Carolina
Cary, North Carolina, United States, 27518
Salisbury, North Carolina, United States, 28144
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland, Ohio, United States, 44195
Mentor, Ohio, United States, 44060
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73160
United States, Oregon
Portland, Oregon, United States, 97210
United States, Pennsylvania
Bethlehem, Pennsylvania, United States, 18017
Perkasie, Pennsylvania, United States, 18944
Philadelphia, Pennsylvania, United States, 19107
Pittsburgh, Pennsylvania, United States, 15243
United States, Rhode Island
Warwick, Rhode Island, United States, 02886
United States, Tennessee
Chattanooga, Tennessee, United States, 37421
United States, Texas
Dallas, Texas, United States, 75321
San Antonio, Texas, United States, 78229
United States, Utah
Saint George, Utah, United States, 84790
Salt Lake City, Utah, United States, 84109
United States, Virginia
Alexandria, Virginia, United States, 22304
Charlottesville, Virginia, United States, 22911
United States, Washington
Seattle, Washington, United States, 98104
Canada, Alberta
Edmonton, Alberta, Canada, T6G2X8
Canada, British Columbia
Abbotsford, British Columbia, Canada, V2T3R7
Kelowna, British Columbia, Canada, V1Y1Z9
Vancouver, British Columbia, Canada, V6Z2K5
Victoria, British Columbia, Canada, V8V3P9
Canada, Ontario
Hamilton, Ontario, Canada, L854J9
Sponsors and Collaborators
Innovate Biopharmaceuticals
Teva Pharmaceuticals USA
Study Director: Henrik Rasmussen, MD, PhD Sponsor GmbH

Publications of Results:
Responsible Party: Innovate Biopharmaceuticals Identifier: NCT01396213     History of Changes
Other Study ID Numbers: Clin1001-012
First Posted: July 18, 2011    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Innovate Biopharmaceuticals:
larazotide acetate

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases