Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
AST-120 in Active Pouchitis
NCT00583076Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2007
- Primary completion
- Mar 2008
- Countries
- 1
- Sponsor
- Ocera Therapeutics
- Drugs
- activated charcoal
- Conditions
- pouchitis
01
Overview
Phase 2, open-label, single-arm trial of activated charcoal in pouchitis, sponsored by Ocera Therapeutics. Primary endpoints: Remission induction as defined by a Pouchitis Disease Activity Index (PDAI) score < 7 at 4 weeks, Maintenance of remission over 12 months at 52 weeks and 1 more. Started Feb 2007; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
AST-120 Arm
All patients receive AST-120 2g sachets three times a day.
03
Who it enrols
Patients with active pouchitis (PDAI > 7) after IPAA for UC, excluding those with Crohn's disease, specific infections, or recent use of antibiotics, probiotics, or other IBD medications.
04
Endpoints
Primary
Remission induction as defined by a Pouchitis Disease Activity Index (PDAI) score < 7
Maintenance of remission over 12 months
Adverse events related to treatment
Secondary
Clinical response defined as a >= 3 point reduction in the 18-point PDAI
Reduction of PDAI clinical symptom score
Reduction of PDAI endoscopic score
Reduction of PDAI histology score
Need for rescue medication or increased antidiarrheal medication
Cleveland Global Quality of Life
Short Inflammatory Bowel Disease Questionnaire
Liver transaminases
Beyond the preview
Go deeper on NCT00583076.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00583076.