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Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00889473
First Posted: April 29, 2009
Last Update Posted: September 20, 2017
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.
Information provided by (Responsible Party):
Innovate Biopharmaceuticals
April 27, 2009
April 29, 2009
September 20, 2017
April 2009
November 2009   (Final data collection date for primary outcome measure)
Response to gluten [ Time Frame: 6 weeks ]
Same as current
Complete list of historical versions of study NCT00889473 on ClinicalTrials.gov Archive Site
Anti-transglutaminase [ Time Frame: 6 weeks ]
Same as current
Not Provided
Not Provided
 
Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease
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
This study is designed to evaluate the efficacy of a single dose of larazotide acetate in preventing intestinal permeability changes induced by a 6-week gluten challenge in subjects with celiac disease

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.

Interventional
Phase 2
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
Celiac Disease
  • Drug: Larazotide acetate
    gelatin capsule
    Other Names:
    • AT1001
    • INN-202
  • Drug: Placebo
    gelatin capsule
  • Dietary Supplement: Gluten 900 mg
    gelatin capsule
  • Experimental: Larazotide acetate 1 mg
    larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
    Interventions:
    • Drug: Larazotide acetate
    • Dietary Supplement: Gluten 900 mg
  • Placebo Comparator: Placebo
    placebo capsules TID + 900 mg gluten capsules TID for 6 weeks
    Interventions:
    • Drug: Placebo
    • Dietary Supplement: Gluten 900 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
April 2010
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 72 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00889473
CLIN1001-006 Part B
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Innovate Biopharmaceuticals
Innovate Biopharmaceuticals
Not Provided
Study Director: Francisco Leon, MD, PhD Alba Therapeutics Inc
Innovate Biopharmaceuticals
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP