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

Stopped early · Phase 2

Conditions studied: Gastroesophageal Reflux Disease (GERD)

In brief

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.

Key facts

Study ID

NCT00587275

Run by

Ocera Therapeutics

People needed

4

Starts

2007-10-01

Expected to finish

2008-06-01

Last updated by the study team

2014-06-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Southern Arizona VA Health Care System and University of Arizona Health Sciences Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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