Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease
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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. |
| ClinicalTrials.gov Identifier: NCT00889473 |
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Recruitment Status :
Completed
First Posted : April 29, 2009
Last Update Posted : September 20, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Celiac Disease | Drug: Larazotide acetate Drug: Placebo Dietary Supplement: Gluten 900 mg | Phase 2 |
This study is an extension of Study CLIN1001-006 (NCT 00492960). This is a Phase IIb, randomized, double-blind, placebo-controlled, dose ranging, multicenter study to determine the safety, tolerance, and efficacy of larazotide acetate in subjects with celiac disease during a gluten challenge. Subjects will remain on their gluten-free diet throughout the duration of the trial.
Study drug or drug placebo capsules will be administered TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with each meal.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 42 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | randomized, double-blind, placebo-controlled, dose ranging, multicenter |
| Masking: | Double (Participant, Investigator) |
| Masking Description: | double-blind |
| Primary Purpose: | Treatment |
| Official Title: | A Phase IIb, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of Larazotide Acetate (AT-1001) in Celiac Disease Subjects During a Gluten Challenge |
| Actual Study Start Date : | April 2009 |
| Actual Primary Completion Date : | November 2009 |
| Actual Study Completion Date : | April 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Larazotide acetate 1 mg
larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
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Drug: Larazotide acetate
gelatin capsule
Other Names:
Dietary Supplement: Gluten 900 mg gelatin capsule |
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Placebo Comparator: Placebo
placebo capsules TID + 900 mg gluten capsules TID for 6 weeks
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Drug: Placebo
gelatin capsule Dietary Supplement: Gluten 900 mg gelatin capsule |
- Response to gluten [ Time Frame: 6 weeks ]
- Anti-transglutaminase [ Time Frame: 6 weeks ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 72 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months
- Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU.
- BMI between 18.5 and 38, inclusive.
Exclusion Criteria
- Has chronic active GI disease other than celiac disease
- Has diabetes (Type 1 or Type 2).
- Unable to abstain from alcohol consumption or NSAID use for 48 hours prior to each intestinal permeability collection throughout the study.
- Has hemoglobin value below 8.5 g/dL
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 ClinicalTrials.gov identifier (NCT number): NCT00889473
| United States, California | |
| Study Site | |
| Orange, California, United States | |
| United States, Kansas | |
| Study Site | |
| Topeka, Kansas, United States | |
| United States, Kentucky | |
| Study Site | |
| Lexington, Kentucky, United States | |
| United States, Maryland | |
| Study Site | |
| Hagerstown, Maryland, United States | |
| Study Site | |
| Silver Spring, Maryland, United States | |
| United States, Michigan | |
| Study Site | |
| Chesterfield, Michigan, United States | |
| Study Site | |
| Troy, Michigan, United States | |
| United States, Minnesota | |
| Study Site | |
| Rochester, Minnesota, United States | |
| United States, New York | |
| Study Site | |
| New York, New York, United States | |
| United States, Oklahoma | |
| Study Site | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| Study Site | |
| Paoli, Pennsylvania, United States | |
| Study Site | |
| Philadelphia, Pennsylvania, United States | |
| Study Site | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Tennessee | |
| Study Site | |
| Franklin, Tennessee, United States | |
| Canada, Alberta | |
| Study Site | |
| Edmonton, Alberta, Canada | |
| Study Director: | Francisco Leon, MD, PhD | Alba Therapeutics Inc |
| Responsible Party: | Innovate Biopharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00889473 History of Changes |
| Other Study ID Numbers: |
CLIN1001-006 Part B |
| First Posted: | April 29, 2009 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:
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larazotide acetate gluten |
Additional relevant MeSH terms:
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Celiac Disease Malabsorption Syndromes Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases |