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

This study has been completed.
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Alba Therapeutics
ClinicalTrials.gov Identifier:
NCT01396213
First received: July 14, 2011
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Celiac Disease
Drug: Larazotide Acetate 0.5 mg
Drug: Larazotide Acetate 1 mg
Drug: Larazotide Acetate 2 mg
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease

Resource links provided by NLM:


Further study details as provided by Alba Therapeutics:

Primary Outcome Measures:
  • Celiac disease domains of the gastrointestinal symptoms rating scale [ Time Frame: From baseline to end of 12-week DB treatment period ] [ Designated as safety issue: No ]

Enrollment: 342
Study Start Date: October 2011
Study Completion Date: November 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Larazotide Acetate 0.5 mg Drug: Larazotide Acetate 0.5 mg
Larazotide Acetate at 0.5 mg TID
Other Name: larazotide acetate
Experimental: Larazotide Acetate 1 mg Drug: Larazotide Acetate 1 mg
Larazotide Acetate 1 mg TID
Other Name: larazotide acetate
Experimental: Larazotide Acetate 2 mg Drug: Larazotide Acetate 2 mg
Larazotide Acetate 2 mg TID
Other Name: larazotide acetate
Placebo Comparator: Placebo Drug: placebo
Placebo
Other Name: placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (select criteria, not all inclusive):

  • biopsy proven and serology-confirmed celiac disease (at any point in time prior to study entry)
  • written informed consent
  • age between 18-75
  • BMI between 18.5-40
  • symptoms despite being on a gluten-free diet (diarrhea, nausea, stomach pain, bloating)
  • must have attempted a gluten-free diet for at least 12 months
  • CeD-GSRS score
  • measurable serology

Exclusion Criteria (select criteria, not all-inclusive):

  • Refractory celiac disease
  • diagnosed with chronic active GI disease, such as irritable bowel syndrome, inflammatory bowel disease etc.
  • severe complications of celiac diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396213

  Hide Study Locations
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
St. 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, 10032
New York, New York, United States, 10016
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
Salt Lake City, Utah, United States, 84109
St. George, Utah, United States, 84790
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
Alba Therapeutics
Teva Pharmaceuticals USA
Investigators
Study Director: Henrik Rasmussen, MD, PhD Sponsor GmbH
  More Information

No publications provided

Responsible Party: Alba Therapeutics
ClinicalTrials.gov Identifier: NCT01396213     History of Changes
Other Study ID Numbers: Clin1001-012
Study First Received: July 14, 2011
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Alba Therapeutics:
celiac disease
gastrointestinal symptoms
gluten-free diet
patients with biopsy-proven celiac disease with symptoms

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

ClinicalTrials.gov processed this record on August 25, 2014