Safety and Efficacy of AST-120 in Patients With GERD Who Continue to be Symptomatic on a Standard Dose of PPI
|Gastroesophageal Reflux Disease (GERD)||Drug: AST-120 Drug: Celphere CP-305||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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)|
- Reduction in the severity of GERD symptoms in patients receiving AST-120 assessed by comparing the symptom scores on the GSAS. [ Time Frame: 8 weeks ]
- Safety endpoint is adverse events (AEs)deemed possibly, probably, or definitely related to treatment with investigational product. [ Time Frame: 8 weeks ]
- Reduction in severity of GERD symptoms in patients receiving AST-120 assessed by patient self assessment using a daily diary. [ Time Frame: 8 weeks ]
- Percent days without heartburn. [ Time Frame: 8 weeks ]
- Percent daytime period without heartburn. [ Time Frame: 8 weeks ]
- Percent change in SF-36 score. [ Time Frame: 8 weeks ]
- Esophageal bilirubin levels as measured by Bilitec. [ Time Frame: 8 weeks ]
- Amount of rescue medication (Gelusil) taken per day. [ Time Frame: 8 weeks ]
- Changes in clinical laboratory tests from baseline. [ Time Frame: 8 weeks ]
- Prior and concomitant medications. [ Time Frame: 8 weeks ]
- Physical examination, vital signs (blood pressure, heart rate, respiration rate and temperature). [ Time Frame: 8 weeks ]
- GI tolerability (diarrhea, constipation, etc). [ Time Frame: 8 weeks ]
|Study Start Date:||October 2007|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
AST-120, 2 gram sachets
Oral, sachet, 2 grams daily for 4 weeks
Placebo Comparator: 2
Celphere CP-305, stained to match appearance of AST-120 in 2g sachets.
Drug: Celphere CP-305
Oral, sachet, 2 grams daily for 4 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587275
|United States, Arizona|
|Southern Arizona VA Health Care System and University of Arizona Health Sciences Center|
|Tucson, Arizona, United States, 85723|
|Principal Investigator:||Ronnie Fass, MD||Southern Arizona VA Health Care System|