Trial record 1 of 23 for:    larazotide acetate
Previous Study | Return to List | Next Study

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Alba Therapeutics
ClinicalTrials.gov Identifier:
NCT01396213
First received: July 14, 2011
Last updated: March 18, 2013
Last verified: June 2012

July 14, 2011
March 18, 2013
October 2011
July 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01396213 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease
A Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Celiac Disease
  • Drug: Larazotide Acetate 0.5 mg
    Larazotide Acetate at 0.5 mg TID
    Other Name: larazotide acetate
  • Drug: Larazotide Acetate 1 mg
    Larazotide Acetate 1 mg TID
    Other Name: larazotide acetate
  • Drug: Larazotide Acetate 2 mg
    Larazotide Acetate 2 mg TID
    Other Name: larazotide acetate
  • Drug: placebo
    Placebo
    Other Name: placebo
  • Experimental: Larazotide Acetate 0.5 mg
    Intervention: Drug: Larazotide Acetate 0.5 mg
  • Experimental: Larazotide Acetate 1 mg
    Intervention: Drug: Larazotide Acetate 1 mg
  • Experimental: Larazotide Acetate 2 mg
    Intervention: Drug: Larazotide Acetate 2 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
320
November 2013
July 2013   (final data collection date for primary outcome measure)

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

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01396213
Clin1001-012
No
Alba Therapeutics
Alba Therapeutics
Teva Pharmaceuticals USA
Study Director: Henrik Rasmussen, MD, PhD Sponsor GmbH
Alba Therapeutics
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP