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Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Innovate Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00492960
First received: June 25, 2007
Last updated: September 15, 2017
Last verified: September 2017
June 25, 2007
September 15, 2017
August 2007
October 2008   (Final data collection date for primary outcome measure)
Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge. [ Time Frame: Following ingestion of a solution of lactulose and mannitol; lactulose and mannitol excretion was quantified and the LAMA ratio calculated from overnight urine specimens collected on Days 7, 21, 35, 49 and 56. ]
The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten
To evaluate the efficacy of multiple dose levels of AT-1001 in preventing intestinal permeability changes induced by a 6- week gluten challenge.
Complete list of historical versions of study NCT00492960 on ClinicalTrials.gov Archive Site
  • Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals [ Time Frame: Up to 6 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
  • To prospectively validate a composite, weighted index of celiac disease activity [ Time Frame: GSRS was completed weekly throughout the study. ]
    Gastrointestinal symptoms were assessed by the GSRS patient self‐assessment questionnaire
To prospectively validate a composite, weighed index of celiac disease activity
Not Provided
Not Provided
 
Study to Assess the Efficacy of Larazotide Acetate for the Treatment of 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 was conducted to evaluate the efficacy of multiple doses of larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects with celiac disease.
This was 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 remained on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules were 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 Study
Masking: Double (Participant, Investigator)
Masking Description:
Double-blind
Primary Purpose: Treatment
Celiac Disease
  • Drug: larazotide acetate
    gelatin capsules
    Other Names:
    • AT-1001
    • INN-202
  • Drug: placebo
    gelatin capsules
  • Dietary Supplement: 900 mg gluten
    gelatin capsules
  • 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: 900 mg gluten
  • Experimental: Larazotide acetate 4 mg
    larazotide acetate 4 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
    Interventions:
    • Drug: larazotide acetate
    • Dietary Supplement: 900 mg gluten
  • Experimental: Larazotide acetate 8 mg
    larazotide acetate 8 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
    Interventions:
    • Drug: larazotide acetate
    • Dietary Supplement: 900 mg gluten
  • Placebo Comparator: Placebo
    placebo capsules TID + 900 mg gluten capsules TID for 6 weeks
    Interventions:
    • Drug: placebo
    • Dietary Supplement: 900 mg gluten
Kelly CP, Green PH, Murray JA, Dimarino A, Colatrella A, Leffler DA, Alexander T, Arsenescu R, Leon F, Jiang JG, Arterburn LA, Paterson BM, Fedorak RN; Larazotide Acetate Celiac Disease Study Group. Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study. Aliment Pharmacol Ther. 2013 Jan;37(2):252-62. doi: 10.1111/apt.12147. Epub 2012 Nov 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
March 2009
October 2008   (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
 
 
NCT00492960
CLIN1001-006
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, Ph.D. Alba Therapeutics Corp
Innovate Biopharmaceuticals
September 2017

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