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Trial · Interventional

CompletedPhase 2Registry data

A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

NCTNCT01396213 (opens ClinicalTrials.gov in a new tab)Other idClin1001-012
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States, Canada

Start
7 Nov 2011
Primary completion
20 Aug 2013
Completion
20 Aug 2013
First posted
18 Jul 2011 (estimated)
Last update posted
20 Sept 2017
Conditions
Celiac Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2011201220132014
  1. Ph 2

    A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

    NCT01396213

    7 Nov 2011 to 20 Aug 2013

Registry summary

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

A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.

Interventions

  • Larazotide AcetateDrug
  • placeboDrug

Arms4

  • Experimental

    Larazotide Acetate 0.5 mg

    larazotide acetate 0.5 mg capsules TID

  • Experimental

    Larazotide Acetate 1 mg

    larazotide acetate 1 mg capsules TID

  • Experimental

    Larazotide Acetate 2 mg

    larazotide acetate 2 mg capsules TID

  • Placebo comparator

    Placebo

    placebo capsules TID

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Assess the efficacy of larazotide acetate versus placebo for the treatment of celiac disease in adults as an adjunct to a gluten-free diet

    Time frame · CeD GSRS was completed weekly Baseline through the end of 12-week double-blind treatment period.

    Registry description

    The primary efficacy endpoint was average on-treatment (Baseline to Week 12) score of theCeliac Disease Gastrointestinal Symptom Rating Scale (CeD GSRS).

Secondary outcomes(3)

  1. Assess the safety and tolerability of larazotide acetate in subjects with active celiac disease

    Time frame · Up to 12 weeks

    Registry description

    Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results, concomitant medication usage and ECG results

  2. Validate a CeD PRO diary instrument in subjects with celiac disease

    Time frame · The CeD PRO was administered daily throughout the study.

    Registry description

    The CeD PRO is a 12-item questionnaire that was developed to assess symptom severity in clinical trials in subjects with celiac disease. Items in the questionnaire were formulated based on one-on-one interviews with subjects with celiac disease and thus reflect the symptoms that subjects consider part of their celiac disease experience. Subjects rated their symptom severity on an 11-point (0-10) scale. Symptoms included abdominal cramping, abdominal pain, bloating, constipation, diarrhea, gas, loose stools, nausea, vomiting, headache, and tiredness. The questionnaire was designed as a self-administered daily diary, to be completed at the same time each day, and required \< 10 minutes to complete.

  3. Compare various efficacy endpoints during 12 weeks of double-blind treatment

    Time frame · GSRS - weekly; BSFS - daily; CGA - screening, baseline, Week 12 and follow-up visits; CeD-QoL and SF12v2 - start of placebo run-in, Week 12 and follow-up visits; CD and CFDCQ - follow-up visit.

    Registry description

    Additional efficacy assessments comprised a variety of known scales used for evaluating subjects with celiac disease, including the Gastrointestinal Symptoms Rating Scale (GSRS), Bristol Stool Form Scale (BSFS), Short Form 12 health survey Version 2 (SF12v2), Celiac Disease Quality of Life (CeD-QoL) scale, and the Clinical Global Assessment (CGA). A Gluten-Free Diet Compliance Questionnaire (GFDCQ) and Celiac Dietary Adherence Test (CDAT) were also included to assess compliance with the gluten-free diet.

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 · 2015

9 results

Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial.

Leffler et al. 2015Gastroenterologycited by 178

PMID 25683116PMC4446229DOI 10.1053/j.gastro.2015.02.008PUB-25683116

Rights unknown9 results
Source linkSee results (9)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male and female adults with biopsy proven and serology-confirmed celiac disease on a gluten-free diet for at least 12 months * measurable serology at screening * CeD GSRS score of ≥ 2.0 prior to randomization * experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nausea, or stomachache) * willing to maintain current diet gluten-free diet throughout the duration of the study. Exclusion Criteria: * refractory celiac disease or severe complications of celiac disease (eg, EATL, ulcerative jejunitis, perforation, etc.) * chronic active GI disease other than celiac disease * diabetes (Type 1 or 2) or other autoimmune disease that might interfere with the conduct of the study * hemoglobin value \< 8.5 g/dL

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