Ignite Creation Date:
2024-05-05 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 9:40 AM
Study NCT ID:
NCT00587275
Status:
TERMINATED
Last Update Posted:
2014-06-18
First Post:
2007-12-21
Brief Title:
Safety and Efficacy of AST-120 in Patients With GERD Who Continue to be Symptomatic on a Standard Dose of PPI
Sponsor:
Ocera Therapeutics
Organization:
Ocera Therapeutics
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated for lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 placebofor the following four weeks
Detailed Description:
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-36Quality 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
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-36Quality 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None