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

This study has been completed.
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Alba Therapeutics
ClinicalTrials.gov Identifier:
NCT01396213
First received: July 14, 2011
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Celiac Disease
Drug: Larazotide Acetate 0.5 mg
Drug: Larazotide Acetate 1 mg
Drug: Larazotide Acetate 2 mg
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease

Resource links provided by NLM:


Further study details as provided by Alba Therapeutics:

Primary Outcome Measures:
  • Celiac disease domains of the gastrointestinal symptoms rating scale [ Time Frame: From baseline to end of 12-week DB treatment period ] [ Designated as safety issue: No ]

Enrollment: 342
Study Start Date: October 2011
Study Completion Date: November 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Larazotide Acetate 0.5 mg Drug: Larazotide Acetate 0.5 mg
Larazotide Acetate at 0.5 mg TID
Other Name: larazotide acetate
Experimental: Larazotide Acetate 1 mg Drug: Larazotide Acetate 1 mg
Larazotide Acetate 1 mg TID
Other Name: larazotide acetate
Experimental: Larazotide Acetate 2 mg Drug: Larazotide Acetate 2 mg
Larazotide Acetate 2 mg TID
Other Name: larazotide acetate
Placebo Comparator: Placebo Drug: placebo
Placebo
Other Name: placebo

Detailed Description:

This is a double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of three different doses (0.5, 1 and 2 mg TID) of Larazotide Acetate as an adjunct to gluten-free diet in the treatment of patients with celiac disease (CD). The diagnosis of CD must have been established by jejunal biopsy as well as serology at some point in time prior to entry into the study. Patients must have symptoms despite being on a gluten-free diet as defined by a celiac disease domain of the gastrointestinal symptoms rating scale equal to or more than 2.0.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (select criteria, not all inclusive):

  • biopsy proven and serology-confirmed celiac disease (at any point in time prior to study entry)
  • written informed consent
  • age between 18-75
  • BMI between 18.5-40
  • symptoms despite being on a gluten-free diet (diarrhea, nausea, stomach pain, bloating)
  • must have attempted a gluten-free diet for at least 12 months
  • CeD-GSRS score
  • measurable serology

Exclusion Criteria (select criteria, not all-inclusive):

  • Refractory celiac disease
  • diagnosed with chronic active GI disease, such as irritable bowel syndrome, inflammatory bowel disease etc.
  • severe complications of celiac diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396213

  Show 62 Study Locations
Sponsors and Collaborators
Alba Therapeutics
Teva Pharmaceuticals USA
Investigators
Study Director: Henrik Rasmussen, MD, PhD Sponsor GmbH
  More Information

No publications provided

Responsible Party: Alba Therapeutics
ClinicalTrials.gov Identifier: NCT01396213     History of Changes
Other Study ID Numbers: Clin1001-012
Study First Received: July 14, 2011
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Alba Therapeutics:
celiac disease
gastrointestinal symptoms
gluten-free diet
patients with biopsy-proven celiac disease with symptoms

Additional relevant MeSH terms:
Celiac Disease
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases

ClinicalTrials.gov processed this record on November 19, 2014