Gastroesophageal Reflux Disease (GERD) Clinical Trial
Official title:
A Double-Blind, Randomized, Placebo-Controlled Crossover Study to Assess the Efficacy of AST-120 in Patients With Gastroesophageal Reflux Disease (GERD) Who Continue to be Symptomatic on a Standard Dose of Proton Pump Inhibitor (PPI)
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.
This is a double-blind, randomized, placebo-controlled, crossover trial where 20 patients
with confirmed persistent GERD symptoms (at least twice weekly) after a standard course of
PPI, with abnormal bile reflux levels but normal esophageal acid exposure are randomized to
initially receive either AST-120 or placebo for a period of 4 weeks after a two week
screening period. After a washout period of one week, patients will cross over to the
opposite blinded treatment.
The experimental drug AST-120 is composed of black, odorless spherical carbon particles in
2g sachets (aluminum foil pouches). The placebo consists of microcrystalline cellulose
spheres, Celphere CP-305, stained to match the appearance of AST-120, in 2g sachets
(aluminum foil pouches). Both AST-120 and placebo are oral (taken by mouth) preparations.
Both are tasteless. Take the product, patients will tear open the sachet, drop the contents
directly on their tongue and wash it down with 8 ounces of water.
Patients will continue to receive the previously prescribed PPI throughout the duration of
the trial. In addition, patients will be allowed up to 6 Gelusil tablets daily as a "rescue
medication".
Patients will be expected to participate in approximately 5 in-clinic visits. During these
visits, patients will undergo a number of tests including: comprehensive physical,
hematology panel, a urine pregnancy test for pre-menopausal females, completion of the
Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) and Short-Form-36
(SF-36)Quality of Life Form and an upper endoscopy will be performed to determine the extent
of esophageal inflammation.
Patients will be allowed to continue on their previously prescribed PPI with no changes and
may take up to 6 Gelusil tablets per day. The following therapies must be discontinued and
should not be taken during the trial: H2receptor antagonists, NSAIDs, Baclofen and Antacids
(OTC or prescription).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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