Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321412
Status:
COMPLETED
Last Update Posted:
2014-05-30
First Post:
2006-05-01
Brief Title:
Safety and Efficacy of AST-120 in Mild to Moderate Crohns Patients With Fistulas
Sponsor:
Ocera Therapeutics
Organization:
Ocera Therapeutics
Study Overview
Official Title:
A Double-blind Randomized Placebo-controlled Multicenter Study to Assess the Safety and Efficacy of AST-120 in Mild to Moderately Active Crohns Patients With Fistulas
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohns disease who have fistulas The study will test whether or not patients receiving AST-120 experience a greater reduction in number of draining fistulas and improvement of their other Crohns disease symptoms versus patients who receive placebo material that does not contain any active medication
Detailed Description:
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 mouthpreparations Both are tasteless To take the product patients will tear open the sachets drop the contents directly on their tongue and wash it down with 8 ounces of water
Patients will be randomly assigned like the toss of a coin to receive either AST-120 or placebo Patients will have a 5050 chance of receiving placebo Patients who participate in this study will be required to take a single dose of study drug AST-120 or placebo 3 times a day 30 minutes after a meal for 8 weeks and be evaluated at Week 4 and Week 8 This is a blinded treatment which means that neither the patient nor the study doctor will know if the patient has received study drug or placebo
If at the end of the first full course of randomized treatment 8 weeks patients are not showing an improvement in their condition they may have the option to receive the alternate blinded treatment for one treatment course 8 weeks The study doctor will discuss this option with each patient individually During this second course of treatment patients will be evaluated at Week 12 and Week 16 If the patient does not respond to the alternate blinded treatment or their condition worsens after 4 weeks assessed at Week 12 they may be removed from the study at the discretion of the investigator
If patients respond to either the initial treatment or the alternate blinded treatment they will have monthly doctorclinic visits for up to 6 months Week 24 or until their condition worsens or they relapse Patients will not receive any study drug during this follow-up period
Relapse is defined for this study as
an increase by 1 or more in the number of draining fistulas for 2 sequential visits versus the number present at the time of response response is defined as at least a 50 reduction in the number of draining fistulas at either Week 8 or for those patients receiving alternate blinded treatment Week 16
There are a maximum of 8 patient evaluation visits in this study Screen Baseline Week 4 Week 8 Week 12 Week 16 Week 20 and Week 24 Evaluations at most of these visits include a review of concomitant medications medical historyadverse events physical exam fistula exam blood draws for safety labs urine pregnancy tests for females and measurement of body weight Patients will also be asked to keep a daily diary to record frequency of bowel movements general well-being and use of antidiarrheal medication
Treatment failure in this study is defined by one or more of the following occurring prior to Week 8
The need for additional therapies or dose increase for treatment of Crohns disease including an increase of corticosteroid dose to higher than baseline
Clinicalsymptomatic development of an abscess
Clinicalsymptomatic evidence of stricture
The need for surgical intervention for Crohns disease
The patient withdraws from the study
Patients will be discontinued from the study at any time if one or more of the following complications occur
Development of an abscess or symptomatic stricture
The need for surgical intervention for Crohns disease
Occurrence of any other event that in the opinion of the investigator warrants discontinuation of the patient from the study
In addition patients whose CDAI score has risen by or 70 points above baseline or risen above 400 will be discontinued from the study
Administration of any additional therapies or dose increases of concomitant medications including corticosteroids to control Crohns disease to higher than baseline while receiving study drug initial randomized treatment or alternate blinded treatment will require discontinuation of the patient from the study
Discontinued patients will be evaluated in a termination visit to document the lack of treatment efficacy and no further study treatment will be given
Patients will be randomly assigned like the toss of a coin to receive either AST-120 or placebo Patients will have a 5050 chance of receiving placebo Patients who participate in this study will be required to take a single dose of study drug AST-120 or placebo 3 times a day 30 minutes after a meal for 8 weeks and be evaluated at Week 4 and Week 8 This is a blinded treatment which means that neither the patient nor the study doctor will know if the patient has received study drug or placebo
If at the end of the first full course of randomized treatment 8 weeks patients are not showing an improvement in their condition they may have the option to receive the alternate blinded treatment for one treatment course 8 weeks The study doctor will discuss this option with each patient individually During this second course of treatment patients will be evaluated at Week 12 and Week 16 If the patient does not respond to the alternate blinded treatment or their condition worsens after 4 weeks assessed at Week 12 they may be removed from the study at the discretion of the investigator
If patients respond to either the initial treatment or the alternate blinded treatment they will have monthly doctorclinic visits for up to 6 months Week 24 or until their condition worsens or they relapse Patients will not receive any study drug during this follow-up period
Relapse is defined for this study as
an increase by 1 or more in the number of draining fistulas for 2 sequential visits versus the number present at the time of response response is defined as at least a 50 reduction in the number of draining fistulas at either Week 8 or for those patients receiving alternate blinded treatment Week 16
There are a maximum of 8 patient evaluation visits in this study Screen Baseline Week 4 Week 8 Week 12 Week 16 Week 20 and Week 24 Evaluations at most of these visits include a review of concomitant medications medical historyadverse events physical exam fistula exam blood draws for safety labs urine pregnancy tests for females and measurement of body weight Patients will also be asked to keep a daily diary to record frequency of bowel movements general well-being and use of antidiarrheal medication
Treatment failure in this study is defined by one or more of the following occurring prior to Week 8
The need for additional therapies or dose increase for treatment of Crohns disease including an increase of corticosteroid dose to higher than baseline
Clinicalsymptomatic development of an abscess
Clinicalsymptomatic evidence of stricture
The need for surgical intervention for Crohns disease
The patient withdraws from the study
Patients will be discontinued from the study at any time if one or more of the following complications occur
Development of an abscess or symptomatic stricture
The need for surgical intervention for Crohns disease
Occurrence of any other event that in the opinion of the investigator warrants discontinuation of the patient from the study
In addition patients whose CDAI score has risen by or 70 points above baseline or risen above 400 will be discontinued from the study
Administration of any additional therapies or dose increases of concomitant medications including corticosteroids to control Crohns disease to higher than baseline while receiving study drug initial randomized treatment or alternate blinded treatment will require discontinuation of the patient from the study
Discontinued patients will be evaluated in a termination visit to document the lack of treatment efficacy and no further study treatment will be given
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