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)
Verified date | June 2014 |
Source | Ocera Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Southern Arizona VA Health Care System and University of Arizona Health Sciences Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Ocera Therapeutics |
United States,
Araki Y, Tsujikawa T, Andoh A, Sasaki M, Fujiyama Y, Bamba T. Therapeutic effects of an oral adsorbent on acute dextran sulphate sodium-induced colitis and its recovery phase in rats, especially effects of elimination of bile acids in gut lumen. Dig Liver Dis. 2000 Nov;32(8):691-8. — View Citation
Fass R, Shapiro M, Dekel R, Sewell J. Systematic review: proton-pump inhibitor failure in gastro-oesophageal reflux disease--where next? Aliment Pharmacol Ther. 2005 Jul 15;22(2):79-94. Review. — View Citation
Fennerty MB. Review article: alternative approaches to the long-term management of GERD. Aliment Pharmacol Ther. 2005 Dec;22 Suppl 3:39-44. Review. — View Citation
Fukuda Y, Takazoe M, Sugita A, et al. The treatment with an oral spherical adsorptive carbon (AST-120) improves anal fistula, PDAI and CDAI scores - A randomized double-blind placebo controlled trial. Abstract #765 presented at Digestive Disease Week meeting, Los Angeles, CA May 24, 2006
Xu XR, Li ZS, Zou DW, Xu GM, Ye P, Sun ZX, Wang Q, Zeng YJ. Role of duodenogastroesophageal reflux in the pathogenesis of esophageal mucosal injury and gastroesophageal reflux symptoms. Can J Gastroenterol. 2006 Feb;20(2):91-4. — View Citation
Yamazaki Z, Fujimori T, Yoshimoto T, et al. Effect of Oral Adsorbent on Animal Models of Hepatic Failure 92(2):331-335, 1980
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in the severity of GERD symptoms in patients receiving AST-120 assessed by comparing the symptom scores on the GSAS. | 8 weeks | No | |
Primary | Safety endpoint is adverse events (AEs)deemed possibly, probably, or definitely related to treatment with investigational product. | 8 weeks | Yes | |
Secondary | Reduction in severity of GERD symptoms in patients receiving AST-120 assessed by patient self assessment using a daily diary. | 8 weeks | No | |
Secondary | Percent days without heartburn. | 8 weeks | No | |
Secondary | Percent daytime period without heartburn. | 8 weeks | No | |
Secondary | Percent change in SF-36 score. | 8 weeks | No | |
Secondary | Esophageal bilirubin levels as measured by Bilitec. | 8 weeks | No | |
Secondary | Amount of rescue medication (Gelusil) taken per day. | 8 weeks | No | |
Secondary | Changes in clinical laboratory tests from baseline. | 8 weeks | Yes | |
Secondary | Prior and concomitant medications. | 8 weeks | Yes | |
Secondary | Physical examination, vital signs (blood pressure, heart rate, respiration rate and temperature). | 8 weeks | Yes | |
Secondary | GI tolerability (diarrhea, constipation, etc). | 8 weeks | Yes |
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