Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects
A Phase 2a, 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 Gluten Challenge.
1 other identifier
interventional
80
1 country
9
Brief Summary
This study was run to determine the safety, tolerance, and efficacy of multiple doses of larazotide acetate in subjects with celiac disease following a gluten challenge.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2006
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2006
CompletedFirst Posted
Study publicly available on registry
August 10, 2006
CompletedStudy Start
First participant enrolled
September 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2007
CompletedSeptember 12, 2017
September 1, 2017
6 months
August 8, 2006
September 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To demonstrate the safety and tolerability of multiple, oral doses of larazotide acetate in celiac disease subjects that maintain a gluten-free diet.
Safety endpoints assessed in this study were adverse events, vital signs, hematology, clinical chemistry, urinalysis and ECG
Safety measurements were performed at Screening and at Day 0, 7, 14, and 21 ('End of Study'). Any change from baseline value was calculated at each subsequent visit until "End of Study" (Day 21).
To evaluate the efficacy of multiple dose levels of larazotide acetate in preventing intestinal permeability changes induced by gluten challenge
The primary efficacy outcome was the Day 0-to-Day 14 change in urinary LAMA ratio ( a measure of intestinal permeability) as a response to gluten
On Days 0, 6, 13, and 20 subjects drank a solution of lactulose and mannitol. Subject's urine was collected during the day on Day 0 and overnight prior to subsequent visits and analyzed for LAMA recoveries via standardized methodologies.
Secondary Outcomes (8)
Changes in daily and weekly reported health outcomes
Symptom diary - daily; PGWBI - weekly; GSRS - weekly
Changes in urinary LAMA ratios between Day 0 to Day 7
See Primary Outcome Measure No. 2
Changes in urinary lactulose fractional excretion between Day 0 to Day 7 to Day 14
See Primary Outcome Measure No. 2
Changes in urinary mannitol fractional excretion between Day 0 to Day 7 to Day 14
See Primary Outcome Measure No. 2
Change in urinary nitrite / nitrate levels from Day 0 to Day 14
Day 0 and Day 14
- +3 more secondary outcomes
Study Arms (7)
Placebo + Gluten
PLACEBO COMPARATORplacebo TID + gluten 800 mg TID administered orally in capsules
Placebo + Gluten placebo
PLACEBO COMPARATORplacebo TID + gluten placebo TID administered orally in capsules
Larazotide acetate 8 mg + Gluten placebo
OTHERSafety Control Arm. Larazotide acetate 8 mg TID + gluten placebo TID administered orally in capsules
Larazotide acetate 0.25 mg + Gluten
ACTIVE COMPARATORLarazotide acetate 0.25 mg TID + gluten 800 mg TID administered orally in capsules
Larazotide acetate 1 mg + Gluten
ACTIVE COMPARATORLarazotide acetate 1 mg TID + gluten 800 mg TID administered orally in capsules
Larazotide acetate 4 mg + Gluten
ACTIVE COMPARATORLarazotide acetate 4 mg TID + gluten 800 mg TID administered orally in capsules
Larazotide acetate 8 mg + Gluten
ACTIVE COMPARATORLarazotide acetate 8 mg TID + gluten 800 mg TID administered orally in capsules
Interventions
capsule
Eligibility Criteria
You may qualify if:
- Must have been diagnosed with celiac disease by biopsy for ≥ 6 months.
- Have a Anti-Tissue Transglutaminase (tTG) ≤ 10 EU as measured by serology.
- Must be on a gluten-free diet for at least the past 6 months.
You may not qualify if:
- Have any chronic active GI disease other than celiac disease (e.g., IBS, Crohn's, Colitis).
- Have diabetes (Type 1 or Type 2).
- Chronically consumes non-steroidal anti-inflammatory agents ("NSAIDs") or takes proton-pump inhibitors.
- Consuming oral corticosteroids or immune suppressants.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Research Site
Scottsdale, Arizona, 85259, United States
Unknown Facility
San Diego, California, 92123, United States
Research Site
Boston, Massachusetts, 02215, United States
Research Site
Rochester, Minnesota, 55905, United States
Unknown Facility
Morristown, New Jersey, 07960, United States
Unknown Facility
Bismarck, North Dakota, 58501, United States
Research Site
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15241, United States
Research Site
Richmond, Virginia, 23298, United States
Related Publications (1)
Leffler DA, Kelly CP, Abdallah HZ, Colatrella AM, Harris LA, Leon F, Arterburn LA, Paterson BM, Lan ZH, Murray JA. A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge. Am J Gastroenterol. 2012 Oct;107(10):1554-62. doi: 10.1038/ajg.2012.211. Epub 2012 Jul 24.
PMID: 22825365RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2006
First Posted
August 10, 2006
Study Start
September 13, 2006
Primary Completion
March 6, 2007
Study Completion
March 6, 2007
Last Updated
September 12, 2017
Record last verified: 2017-09