Overview

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