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

 -  Body weight 40 to 136 kg (88 to 300 lbs)

 -  Recent history of GERD related symptoms (at least twice weekly) confirmed during
 screening.

 -  Recent history of 8 week PPI treatment without significant improvement

 -  Abnormal bilirubin level as assessed by Bilitec

 -  Normal esophageal pH value (pH<4.0 for <4.2% of the time calculated over a 24 hour
 period)

 -  Platelet count (thrombocytes) >100,000/µL

 -  Normal Hgb and Hct levels

 -  Able and willing to comply with all protocol procedures for the planned duration of
 the study

 -  Able and willing to understand, sign and date an informed consent document, and
 authorize access to protected health information.

 -  Females must be postmenopausal, surgically incapable of bearing children, or
 practicing a reliable method of birth control (hormonal contraceptives, intrauterine
 devices, spermicide and barrier). Partner/spouse sterility may also qualify at the
 Investigator's discretion. Females of child-bearing potential must have a negative
 urine pregnancy test at baseline.

 Exclusion Criteria:

 -  Concurrent GI or other pathology which could interfere with the course of the study
 (e.g., erosive esophagitis, malabsorption, cirrhosis, ascites, bleeding ulcer,
 diabetes, scleroderma, non-GI myopathy or neuropathy etc.) Note: patients with
 Barrett's esophagus (short segment defined as < 3 cm) can be included.

 -  Patients with cancer or undergoing chemotherapy for the treatment of cancer

 -  Patients with a history of upper GI surgery

 -  Patients with GERD complications such as stricture of the esophagus

 -  Contraindication to continued PPI treatment

 -  Patients requiring the concomitant use of NSAIDs for the duration of the study

 -  Uncontrolled systemic disease

 -  Diagnosis of a psychiatric disorder within the past 2 years and not on a stable dose
 of medications for at least 6 months

 -  Other major physical or psychiatric illness in previous 6 months as determined by the
 treating physician

 -  Known hypersensitivity or contraindication to any component of the test product (study
 drug) or diagnostics used

 -  Participation in another study within eight (8) weeks prior to randomization

 -  Unable to attend all visits required by the protocol

 -  Pregnant, breast feeding, or planning to become pregnant during the study