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Safety and Efficacy of AST-120 in Patients With GERD Who Continue to be Symptomatic on a Standard Dose of PPI

NCT00587275 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2014-06-18

No results posted yet for this study

Summary

The purpose of this project is to test how safe and how well AST-120, an investigational product, works in treating too much acid in the stomach. Patients will be randomly assigned to one of two groups, AST-120 or a placebo for the first four weeks of the study. The patients will be switched to the other group (AST-120 or placebo)for the following four weeks.

Conditions

  • Gastroesophageal Reflux Disease (GERD)

Interventions

DRUG

AST-120

Oral, sachet, 2 grams daily for 4 weeks

DRUG

Celphere CP-305

Oral, sachet, 2 grams daily for 4 weeks

Sponsors & Collaborators

  • Ocera Therapeutics

    lead INDUSTRY

Principal Investigators

  • Ronnie Fass, MD · Southern Arizona VA Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00587275 on ClinicalTrials.gov