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

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ClinicalTrials.gov Identifier: NCT00492960
Recruitment Status : Completed
First Posted : June 27, 2007
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
9 Meters Biopharma, Inc.

Tracking Information
First Submitted Date  ICMJE June 25, 2007
First Posted Date  ICMJE June 27, 2007
Last Update Posted Date September 20, 2017
Actual Study Start Date  ICMJE August 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2007)
To evaluate the efficacy of multiple dose levels of AT-1001 in preventing intestinal permeability changes induced by a 6- week gluten challenge.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2007)
To prospectively validate a composite, weighed index of celiac disease activity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Celiac Disease
Intervention  ICMJE
  • Drug: larazotide acetate
    gelatin capsules
    Other Names:
    • AT-1001
    • INN-202
  • Drug: placebo
    gelatin capsules
  • Dietary Supplement: 900 mg gluten
    gelatin capsules
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2017)
171
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2007)
2007
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 72 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00492960
Other Study ID Numbers  ICMJE CLIN1001-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party 9 Meters Biopharma, Inc.
Study Sponsor  ICMJE 9 Meters Biopharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Francisco Leon, MD, Ph.D. Alba Therapeutics Corp
PRS Account 9 Meters Biopharma, Inc.
Verification Date September 2017

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