Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis
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ClinicalTrials.gov Identifier: NCT00583531 |
Recruitment Status :
Terminated
(Lack of enrollment)
First Posted : December 31, 2007
Last Update Posted : June 18, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pouchitis | Drug: AST-120 | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Study of the Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis |
Study Start Date : | March 2007 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |
Arm | Intervention/treatment |
---|---|
Experimental: I
Active treatment with AST-120
|
Drug: AST-120
Oral, 2 grams TID in sachets for 4 weeks |
- Response as defined by a decrease in the Pouchitis Diseases Activity Index (PDAI) score of at least 3 points [ Time Frame: 4 weeks ]
- Safety: Any adverse events (AEs) deemed possibly, probably, or definitely related to treatment with investigational product during 4 weeks of treatment [ Time Frame: 4 weeks ]
- Remission, as defined as a PDAI score of less than 7 points [ Time Frame: 4 weeks ]
- Reduction of PDAI clinical symptom subscore of at least 1 point [ Time Frame: 4 weeks ]
- Reduction of PDAI endoscopic subscore of at least 1 point [ Time Frame: 4 weeks ]
- Reduction of PDAI histology subscore of at least 1 point [ Time Frame: 4 weeks ]
- Need for rescue medication/quantity of antidiarrheal medication used during the last week of the trail compared to usage in the week prior to study entry [ Time Frame: 4 weeks ]
- Quality of Life as measured by the Cleveland Global QoL instrument and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) [ Time Frame: 4 weeks ]
- Significant change in clinical laboratory tests [ Time Frame: 4 weeks ]
- Worsening GI symptoms (diarrhea, abdominal pain, urgency or bleeding) or new GI and extra-GI symptoms (e.g., headache, nausea, vomiting, constipation) [ Time Frame: 4 weeks ]
- Significant change in physical examination, including vital signs (blood pressure, heart rate, respiration rate and temperature) [ Time Frame: 4 weeks ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with active pouchitis (defined as having a PDAI score > 7) after IPAA for UC, despite at least 14 days of antibiotic therapy. Active pouchitis must be confirmed by endoscopy and histology within 4 weeks of study entry
- Able to give informed consent
- Able and willing to comply with all study procedures
Exclusion Criteria:
- Patients previously treated with infliximab or any investigational immunosuppressant/ immunomodulator for pouchitis
- Patients undergoing chemotherapy for the treatment of cancer
- Presence of other inflammatory diseases of the pouch: Crohn's disease, Cuffitis, active specific infection of the pouch: (e.g., CMV, C. difficile)
- History of non-inflammatory disease of the pouch: decreased pouch compliance, irritable pouch syndrome, afferent or efferent limb obstruction, stricture of pouch
- Ileal pouch patients with familial adenomatous polyposis
- History of other diarrheal illnesses: lactose intolerance, celiac disease, small bowel bacterial overgrowth
- Primary Sclerosing Cholangitis with or without liver transplant
- Uncontrolled systemic disease
- Needing oral or topical 5-ASA, cholestyramine, steroids or immunomodulators
- Other major physical or major psychiatric illness within the last 6 months that in the opinion of the investigator would affect the patient's ability to complete the trial
- Women who are pregnant, breast feeding, or planning to become pregnant during the study
- Women of child-bearing potential who are not willing to use barrier or depot contraception methods
- Use of NSAIDs or aspirin (>3 times per week) within the past 3 weeks

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583531
United States, Minnesota | |
Mayo Clinic, Inflammatory Bowel Disease Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Darrell S. Pardi, MD | Mayo Clinic College of Medicine |
Responsible Party: | Ocera Therapeutics |
ClinicalTrials.gov Identifier: | NCT00583531 |
Other Study ID Numbers: |
06-007216 |
First Posted: | December 31, 2007 Key Record Dates |
Last Update Posted: | June 18, 2014 |
Last Verified: | June 2014 |
Antibiotic-refractory Pouchitis Pouchitis Ulcerative Colitis |
Pouchitis Ileitis Enteritis Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Ileal Diseases |