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

• Status: Terminated
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ocera Therapeutics

Criteria

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