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Trial · Interventional

CompletedPhase 2Registry data

Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects

NCTNCT00362856 (opens ClinicalTrials.gov in a new tab)Other idCLIN1001-004
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
80 participants (actual)
Sponsor
9 Meters Biopharma, Inc. · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
13 Sept 2006
Primary completion
6 Mar 2007
Completion
6 Mar 2007
First posted
10 Aug 2006 (estimated)
Last update posted
12 Sept 2017
Conditions
Celiac Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008
  1. Ph 2

    Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects

    NCT00362856

    13 Sept 2006 to 6 Mar 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • larazotide acetateDrug
  • PlaceboDrug

Arms7

  • Placebo comparator

    Placebo + Gluten

    placebo TID + gluten 800 mg TID administered orally in capsules

  • Placebo comparator

    Placebo + Gluten placebo

    placebo TID + gluten placebo TID administered orally in capsules

  • Other

    Larazotide acetate 8 mg + Gluten placebo

    Safety Control Arm. Larazotide acetate 8 mg TID + gluten placebo TID administered orally in capsules

  • Active comparator

    Larazotide acetate 0.25 mg + Gluten

    Larazotide acetate 0.25 mg TID + gluten 800 mg TID administered orally in capsules

  • Active comparator

    Larazotide acetate 1 mg + Gluten

    Larazotide acetate 1 mg TID + gluten 800 mg TID administered orally in capsules

  • Active comparator

    Larazotide acetate 4 mg + Gluten

    Larazotide acetate 4 mg TID + gluten 800 mg TID administered orally in capsules

  • Active comparator

    Larazotide acetate 8 mg + Gluten

    Larazotide acetate 8 mg TID + gluten 800 mg TID administered orally in capsules

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. 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).

    Registry description

    Safety endpoints assessed in this study were adverse events, vital signs, hematology, clinical chemistry, urinalysis and ECG

  2. 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.

    Registry description

    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(8)

  1. Changes in daily and weekly reported health outcomes

    Time frame · Symptom diary - daily; PGWBI - weekly; GSRS - weekly

    Registry description

    Health outcomes were assessed using a daily symptom diary; a weekly PGWBI and a weekly GSRS

  2. Changes in urinary LAMA ratios between Day 0 to Day 7

    Time frame · See Primary Outcome Measure No. 2

    Registry description

    See Primary Outcome Measure No. 2

  3. Changes in urinary lactulose fractional excretion between Day 0 to Day 7 to Day 14

    Time frame · See Primary Outcome Measure No. 2

    Registry description

    See Primary Outcome Measure No. 2

  4. Changes in urinary mannitol fractional excretion between Day 0 to Day 7 to Day 14

    Time frame · See Primary Outcome Measure No. 2

    Registry description

    See Primary Outcome Measure No. 2

  5. Change in urinary nitrite / nitrate levels from Day 0 to Day 14

    Time frame · Day 0 and Day 14

    Registry description

    Nitrite/nitrate levels were assessed for correlation to the measures of intestinal permeability

  6. Change in anti-tTG levels from Screening to Day 21

    Time frame · Screening and Day 21

    Registry description

    Changes between screening and Day 21 anti-tTG levels were assessed for correlation to the measures of intestinal permeability

  7. Change in cell markers and cytokines from PBMCs

    Time frame · Days 0, 7, 14 and 21

    Registry description

    Serum cytokine and cell surface marker determinations were assessed for correlation to the measures of intestinal permeability

  8. Changes in zonulin level

    Time frame · Days 0, 7, 14 and 21

    Registry description

    Serum zonulin levels were assessed for correlation to the measures of intestinal permeability

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2012

5 results

A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge.

Leffler et al. 2012The American journal of gastroenterologycited by 138

PMID 22825365PMC3463856DOI 10.1038/ajg.2012.211PUB-22825365

Free to read · publisher termsCC BY-NC-ND5 results
Read at sourceSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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