Safety Study of Larazotide Acetate to Treat Celiac Disease.

Status Completed

Clinical Trial Summary

To demonstrate the safety, pharmacokinetics and efficacy of larazotide acetate in patients with controlled celiac disease on a gluten-free diet following a gluten challenge.

Clinical Trial Description

CLIN1001-002 was a Phase 1b, randomized, double-blind, placebo controlled study to determine the safety, tolerance, pharmacokinetic and pharmacodynamic effects of single doses of larazotide acetate in subjects with celiac disease subjects. Study subjects were randomized (2:1) to receive single oral doses of larazotide acetate 12 mg or matching placebo once daily for 3 days. Subjects received a single-blinded gluten challenge (5 mg amygluten) on Day 2. Intestinal permeability was measured each day following dosing. Intestinal permeability was measured by administration of an oral sucrose, lactulose and mannitol solution followed by a 6-hour urine collection. Serial blood samples were collected for pharmacokinetic determinations at baseline and 2 and 3 hours post dose; for zonulin determinations at baseline (prior to first dose) and 3 hours post dose; and for cytokine determination at baseline and 3 hours post dose (Days 2 and 3 only) and on Day 7. Sucrose, lactulose, mannitol, zonulin and larazotide acetate concentrations were determined by validated analytical methods. ;

Study Design

Related Conditions & MeSH terms

Celiac Disease

Clinical Trial Details

NCT number	NCT00386165
Study type	Interventional
Source	Innovate Biopharmaceuticals
Contact
Status	Completed
Phase	Phase 1
Start date	November 29, 2005
Completion date	January 26, 2006

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04349904` - Near-Focus NBI Classification of Villous Atrophy in Suspected Coeliac Disease: International Development and Validation
Recruiting	`NCT05581628` - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Completed	`NCT04593251` - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis	Phase 1
Completed	`NCT05810441` - Intestinal Transglutaminase Antibodies in Celiac Disease Diagnosis
Recruiting	`NCT05555446` - Bovine Colostrum to Prevent Absorption of Gluten	Early Phase 1
Completed	`NCT02754609` - Hookworm Therapy for Coeliac Disease	Phase 1
Terminated	`NCT01902368` - Celiac Disease Screening	N/A
Completed	`NCT02472704` - Lymphocytic Enteritis and Suspected Coeliac Disease: Gluten vs Placebo	N/A
Completed	`NCT02312349` - Assessment of Gluten-Free Availability in Elaborated Food Stores in Three Neighbourhoods of Buenos Aires City
Recruiting	`NCT01172665` - Celiac Disease Database
Completed	`NCT01100099` - HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease	Phase 2/Phase 3
Completed	`NCT00639444` - Risk of Celiac Disease and Age at Gluten Introduction	N/A
Recruiting	`NCT05425446` - Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients	Phase 1
Enrolling by invitation	`NCT02202681` - Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule	N/A
Completed	`NCT00362856` - Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects	Phase 2
Terminated	`NCT03866538` - Budesonide in Patients With Immune Mediated Enteropathies	Phase 4
Recruiting	`NCT05135923` - Glutenfree, Gut Microbiota and Metabolic Regulation	N/A
Completed	`NCT05052164` - Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women	N/A
Completed	`NCT03775499` - Probiotic BL NCC 2705 and Gluten Sensitivity	N/A
Completed	`NCT03707730` - A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease	Phase 2