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

Celiac Disease Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396213
• Other study ID #: Clin1001-012
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2011
• Last updated: September 15, 2017
• Start date: November 7, 2011
• Est. completion date: August 20, 2013

Study information

• Verified date: September 2017
• Source: Innovate Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: August 20, 2013
• Est. primary completion date: August 20, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Drug:
• Larazotide Acetate
gelatin capsule
• placebo
gelatin capsule

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Innovate Biopharmaceuticals	Teva Pharmaceuticals USA

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Leffler DA, Kelly CP, Green PH, Fedorak RN, DiMarino A, Perrow W, Rasmussen H, Wang C, Bercik P, Bachir NM, Murray JA. Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial. Gastroenterology — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the efficacy of larazotide acetate versus placebo for the treatment of celiac disease in adults as an adjunct to a gluten-free diet	The primary efficacy endpoint was average on-treatment (Baseline to Week 12) score of theCeliac Disease Gastrointestinal Symptom Rating Scale (CeD GSRS).	CeD GSRS was completed weekly Baseline through the end of 12-week double-blind treatment period.
Secondary	Assess the safety and tolerability of larazotide acetate in subjects with active celiac disease	Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results, concomitant medication usage and ECG results	Up to 12 weeks
Secondary	Validate a CeD PRO diary instrument in subjects with celiac disease	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.	The CeD PRO was administered daily throughout the study.
Secondary	Compare various efficacy endpoints during 12 weeks of double-blind treatment	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.	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.