DRUG
larazotide acetate
capsule
Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects
Status
Completed
Phase
Phase 2
Enrollment
80
Locations
9
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Full detailed description
CLIN1001-004 was a randomized, double-blind, placebo controlled, dose-ranging, 7-arm, multicenter study with a gluten challenge. The objects were multiple dose safety and tolerance; efficacy (intestinal permeability \[change in urinary LAMA ratio\] and disease signs and symptoms) following gluten challenge. Following a 21-day screening period, subjects were randomized to one of seven treatments groups: four groups received larazotide acetate (0.25 mg, 1 mg, 4 mg or 8 mg TID) along with an 800 mg gluten challenge, one group received placebo with an 800 mg gluten challenge, a safety control arm received the highest dose of larazotide acetate (8 mg TID) and gluten placebo and the last group received drug placebo and gluten placebo. The gluten challenge was administered as capsules (800 mg TID) with each main meal for a total of 2.4 g daily. Drug or drug placebo was administered TID 15 minutes prior to each main meal. Subjects received their assigned treatments for two weeks (Day 0 through Day 14) and came to clinic for a follow-up visit one week later (Day 21). Subjects remained on their gluten-free diet for the duration of the study.
Interventions
Treatment arms and agents.
DRUG
Placebo
capsule
Timeline
From registration to results.
First posted
Aug 10, 2006
Study start
Sep 13, 2006
Primary completion
Mar 6, 2007
Study completion
Mar 6, 2007
Results posted
Not reported
Registry updated
Sep 12, 2017
Outcomes
What the study measures.
Primary outcomes
To demonstrate the safety and tolerability of multiple, oral doses of larazotide acetate in celiac disease subjects that maintain a gluten-free diet.
Time frame · 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).
Safety endpoints assessed in this study were adverse events, vital signs, hematology, clinical chemistry, urinalysis and ECG
To evaluate the efficacy of multiple dose levels of larazotide acetate in preventing intestinal permeability changes induced by gluten challenge
Time frame · 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.
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
Secondary outcomes
Changes in daily and weekly reported health outcomes
Time frame · Symptom diary - daily; PGWBI - weekly; GSRS - weekly
Health outcomes were assessed using a daily symptom diary; a weekly PGWBI and a weekly GSRS
Changes in urinary LAMA ratios between Day 0 to Day 7
Time frame · See Primary Outcome Measure No. 2
See Primary Outcome Measure No. 2
Changes in urinary lactulose fractional excretion between Day 0 to Day 7 to Day 14
Time frame · See Primary Outcome Measure No. 2
See Primary Outcome Measure No. 2
Changes in urinary mannitol fractional excretion between Day 0 to Day 7 to Day 14
Time frame · See Primary Outcome Measure No. 2
See Primary Outcome Measure No. 2
Change in urinary nitrite / nitrate levels from Day 0 to Day 14
Time frame · Day 0 and Day 14
Nitrite/nitrate levels were assessed for correlation to the measures of intestinal permeability
Change in anti-tTG levels from Screening to Day 21
Time frame · Screening and Day 21
Changes between screening and Day 21 anti-tTG levels were assessed for correlation to the measures of intestinal permeability
Change in cell markers and cytokines from PBMCs
Time frame · Days 0, 7, 14 and 21
Serum cytokine and cell surface marker determinations were assessed for correlation to the measures of intestinal permeability
Changes in zonulin level
Time frame · Days 0, 7, 14 and 21
Serum zonulin levels were assessed for correlation to the measures of intestinal permeability
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Study locations
9 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Research Site
Scottsdale, Arizona, United States
Facility not named
San Diego, California, United States
Research Site
Boston, Massachusetts, United States
Research Site
Rochester, Minnesota, United States
Facility not named
Morristown, New Jersey, United States
Facility not named
Bismarck, North Dakota, United States
Research Site
Philadelphia, Pennsylvania, United States
Facility not named
Pittsburgh, Pennsylvania, United States
Research Site
Richmond, Virginia, United States
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