Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis - Full Text View

Sponsored by:	Ocera Therapeutics
Information provided by:	Ocera Therapeutics
ClinicalTrials.gov Identifier:	NCT00583531

Sponsored by:

Ocera Therapeutics

Information provided by:

Ocera Therapeutics

ClinicalTrials.gov Identifier:

NCT00583531

Purpose

This is an open-label pilot study in which all patients will receive AST-120 for 4 weeks. Patients will discontinue antibiotics at study entry. They may continue other previously prescribed treatments (e.g., probiotics and/or nutritional agents) at the discretion of the study doctor. The purpose of the study is to assess whether the investigational medication AST-120 will be a safe and effective treatment for the symptoms of pouchitis, a chronic inflammatory condition, in patients whose symptoms have not responded well to antibiotics. An initial group of 10 patients will be enrolled. If there are no serious side effects associated with the study drug and at least 3 of the 10 patients respond, a second group of 10 patients may be enrolled. Patients will have clinic visits at the start of the study and at week 4. Patients will be checked by phone on a weekly basis for symptom response, compliance and development of side effects. Endoscopies will be performed at the start of the study and at week 4 or early termination.

Condition	Intervention	Phase
Pouchitis	Drug: AST-120	Phase II

MedlinePlus related topics: Antibiotics Nausea and Vomiting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study of the Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis

Further study details as provided by Ocera Therapeutics:

Primary Outcome Measures:

Response as defined by a decrease in the Pouchitis Diseases Activity Index (PDAI) score of at least 3 points [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Remission, as defined as a PDAI score of less than 7 points [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Reduction of PDAI clinical symptom subscore of at least 1 point [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Reduction of PDAI endoscopic subscore of at least 1 point [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Reduction of PDAI histology subscore of at least 1 point [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Quality of Life as measured by the Cleveland Global QoL instrument and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Significant change in clinical laboratory tests [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Significant change in physical examination, including vital signs (blood pressure, heart rate, respiration rate and temperature) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	March 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Active treatment with AST-120	Drug: AST-120 Oral, 2 grams TID in sachets for 4 weeks

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Responsible Party:	Mayo Clinic ( Darrell Pardi, MD )
Study ID Numbers:	06-007216
Study First Received:	December 20, 2007
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00583531
Health Authority:	United States: Food and Drug Administration

United States, Minnesota
Mayo Clinic, Inflammatory Bowel Disease Clinic
Rochester, Minnesota, United States, 55905